Law Articles

by Jessica Sage 
AUL Staff Counsel
 

Brenda Vise, a 38-year old pharmaceutical representative, died on September 12, 2001.  Holly Patterson, an 18-year old student, died on September 17, 2003.  Chanelle Bryant, 22-years old, died on January 14, 2004.  Vivian Tran, also 22 years old, died on December 29, 2003.  Orianne Shevin, a 34-year old attorney and mother of two, died on June 14, 2005.

What do these women have in common?  They all took RU-486, the so-called “abortion pill,” and died—most from a C. Sordelli infection and one from a ruptured ectopic pregnancy.  RU-486—a drug that its proponents claim is a “safe” and “easy” method of abortion—has killed at least 29 women worldwide including at least 8 American women.

This month marks the 21st anniversary of French approval of the controversial abortion drug.  Initially, the U.S. Food and Drug Administration (FDA) considered RU-486 dangerous and banned the importation of the drug.  However, later in 1993, following the wishes of then-President Bill Clinton, the FDA lifted the import ban and the Department of Health and Human Services (HHS) brokered a deal for the drug manufacturer, Roussel-Uclaf, to gratuitously donate the rights to distribute RU-486 in the U.S. to the Population Council, an organization whose mission is to research, develop and introduce birth control methods (including abortion) to control populations—“especially [for] disadvantage populations.”

Since the Population Council is a research and policy organization, not a drug company, it founded Danco Laboratories for the sole purpose of marketing and distributing RU-486 in the U.S.  Unable to find a U.S. company willing to manufacture the drug, Danco Laboratories turned to China—a nation known for coerced abortions—and a manufacturer formerly cited by the FDA for tainted drugs.

In September 2000—during the final days of the Clinton Administration—the FDA approved RU-486, or Mifeprex (generic name: mifepristone), under its accelerated approval regulations designed to expedite drug approvals for HIV patients.  Suddenly, the FDA deemed that the benefits of RU-486 outweighed the risks and required that it receive expedited approval.  In other words, the FDA succumbed to intense political pressure from the Population Council and abortion advocates to approve the drug.

On its website and in its literature, Danco Laboratories advertises RU-486 as a “safe” and “easy” abortion option.  However, the U.S. trials and subsequent market use are to the contrary.  It is neither safe nor easy. 

A RU-486 or chemical abortion is, in reality, a long, messy, and dangerous process.  RU-486 is a synthetic steroid that requires two drugs and three doctor visits to abort an unborn child at 7 weeks of gestation or less.  During the first visit, the woman takes three pills (Mifeprex) to chemically destroy the unborn child’s environment, deprive him/her of nourishment and subsequently starve the child to death.  During the second visit, if the woman is still pregnant she is given a prostaglandin (misoprostol), which causes cramping to expel the child in something similar to a very heavy and painful (and, at times, deadly) menstruation cycle.  The third office visit (14 days later) confirms the woman is well and the abortion complete.  If the RU-486 abortion is unsuccessful, the women must consider the possibility of birth defects and typically then undergoes a surgical abortion.

The Population Council—with vested interest in the success of RU-486—conducted and reported on the results of the U.S. clinical trials.  Despite the highly-controlled trials conducted from September 1994 to September 1995, the results reported in the New England Journal of Medicine remained alarming.  They revealed how RU-486 creates significant risks of life-threatening complications for the healthiest of women.

The study cited excessive bleeding as the most serious risk.  Excessive bleeding left 4 women needing blood transfusions, 25 women requiring hospitalization (including emergency-room visits), 56 women with “surgical interventions,” and 22 women needing intravenous fluids.  To the logical observer, these “adverse events” would equate to “medical emergencies,” but the Population Council dismissed these life-threatening complications as normal and expected with a chemical abortion.

The studies also indicated that women suffered from abdominal pain, nausea, vomiting and diarrhea.  Abdominal pain, referred to as “cramps,” was so significant that 68% of women received at least one pain medication and 29% received opiates.  One woman was hospitalized for the intense pain and actually needed two “surgical interventions.”

Further, the study results also confirmed that a chemical abortion “procedure” must begin within 49 days of conception, otherwise the baby’s size and development are too advanced and complications are admittedly too severe and dangerous.

Inexplicably, the report paid little attention to the other adverse events women reported including headache (32%); dizziness (12%); back pain (9%); fatigue (9%); fever (4%); vaginitis (4%); viral infections (4%); rigors (3%); dyspepsia (3% ); and asthenia, leg pain, anxiety, insomnia, anemia, syncope, leukorrhea, and sinusitis (2% each).  And if that is not enough, endometritis occurred in 19 women.  These are not just percentages and not simply insignificant statistics, but real women experiencing real complications (some requiring timely life-saving measures) after taking RU-486.

The Population Council acknowledged that the study showed that RU-486 had a low success rate and attempted to rationalize the discrepancy as merely “a lack of experience with [chemical] abortion in the United States as well as the design of [the] study.”  If this is true, then how much lower would the success rate and higher the complication rate be once approved by the FDA and introduced to the uncontrolled and unmonitored marketplace?  Unfortunately, U.S. women are finding out first-hand.

Since its September 2000 FDA approval, RU-486 has caused at least 8 deaths, 9 life-threatening incidents, 116 blood transfusions, and 232 hospitalizations for more than 1,100 women in the U.S. who experienced significant medical complications.  These numbers are only the incidents reported to and by the FDA and are likely an inadequate reflection of actual incidences.

The futile efforts by the FDA to make an unsafe drug acceptably safe by detailing certain limitations on who can prescribe the drug and the protocols to be followed are obviously insufficient.  On November 15, 2004, the FDA issued “important new safety changes” to the labeling of RU-486.  The FDA and drug manufacturer Danco Laboratories had received reports of serious bacterial infection, bleeding, ruptured ectopic pregnancies, and death.  The FDA’s response:  Change the black box labeling and nothing more.  The new label warns health care professionals and consumers about the “risk of serious bacterial infection, bleeding, sepsis, and death,” but does nothing to protect women from these risks actually occurring.

If past care is indicative of future care by abortion providers, none of these warnings will protect women.  Planned Parenthood and other abortion providers have notoriously failed to adhere to the labeling instructions or given appropriate medical attention to women who notify them of these dangerous complications after taking RU-486.  Since its approval, RU-486’s promoters have ignored the minimal FDA guidelines by recommending lower dosages, suggesting clinics drop follow-on visits to allow patients to self administer at home, promoting vaginal versus oral administration, and extending the usage deadline past the seven weeks prescribed by the FDA—all harming women who are entrusting their lives to these “reproductive care” providers. 

States can and must act to regulate and – in the case of minors – limit the use of RU-486.  Current FDA guidelines do nothing to restrict minors from obtaining RU-486 or restrict physicians from implementing the drug in “off-label” uses.  It does require the drug to be provided by or under the supervision of a physician who meets certain qualifications—but most abortion providers meet these requirements and have clearly shown their willingness to prescribe RU-486 in “off-label” and life-threatening ways.

In 2004, the Ohio General Assembly enacted a law requiring abortion providers to comply with the FDA-approval letter and the uses, dosages, and administration protocols contained in the drug label.  In July 2009 —after five years of legal battles with Planned Parenthood—the Ohio Supreme Court answered that the plain language of the law mandates that abortion providers follow the instructions contained in the medication guide and drug labeling when administering or prescribing RU-486.  Subsequently, the Sixth Circuit removed an injunction against the law’s enforcement and remanded the case to the district court.  In light of the dangers associated with RU-486 and its American track record, it is astounding that Planned Parenthood would even argue that it need not follow the approved and “safe” method of administrating RU-486.

States can and should further protect women from RU-486 by imposing administrative regulations on its administration by requiring that abortion providers follow the FDA-approved drug labeling.  Second, to prevent “satellite” prescriptions, states could consider physician-only limits on RU-486 explicitly requiring physicians to be physically present at the abortion facility when they prescribe and administer the drug and clearly prohibiting the delegation of actual administration duties to nurses, physician assistants, or others.  It would also be prudent to require the facilities to be able to provide or be proximate to emergency care and to mandate ultrasounds before prescribing RU-486 to accurately determine the gestational age of the unborn child and to rule out ectopic pregnancy.

Another necessary consideration is for states to review existing—and enact, if nonexistent—parental involvement laws requiring abortion providers to involve parents when a minor girl seeks a RU-486 or other chemical abortion.

Despite the real and evidenced dangers of RU-486, the FDA, the drug manufacturer, and prescribing abortion providers continue to believe the “adverse effects” are not statistically significant.  They continue to profess its safety and ease as more and more women are sacrificed at the altar of “reproductive choice.”  At what point will the harm to women be significant enough for the FDA to pull this deadly drug from the market?  The answer is unclear.  In the meantime, it is imperative to regulate and, when appropriate, restrict the use of RU-486 to protect women and to limit the “collateral damage” abortion advocates are clearly willing to accept.

This article was published with permission from Culture of Life Foundation. To view the original publication, see their website.

By Mailee R. Smith
Staff Counsel
 

This year marks the tenth “anniversary” of the Food and Drug Administration’s (FDA) approval of the “emergency contraceptive,” Plan B.  A decade later, Plan B is not only just as unsafe, but now the drug manufacturer is targeting our children.

The FDA first caved to abortion advocates’ demands in 1999 when it approved the prescription status of Plan B.  While touted as a drug to prevent pregnancy, the drug manufacturer does not hide the fact that it will prevent the implantation of an embryo.

But as we have come to expect, the availability of Plan B through prescription was not enough for abortion advocates.  So in 2001, a group of organizations petitioned the FDA to make Plan B available over the counter.  A lawsuit was also initiated in a federal court in New York.  While at first the FDA denied the request, it caved once again in 2006 when it approved over-the-counter sales of Plan B to women 18 years of age and over.

Not surprisingly, this was not enough for abortion advocates, either.  They complained that the health of minors was at stake because minors did not get unfettered access to Plan B.  Of course, men who impregnate minors can buy Plan B and give it to minors, but this is largely ignored by the abortion advocates.  Maybe because they are too busy trying to hide the abortions of minors whose adult perpetrators were not “smart enough” to buy Plan B in time.

So abortion advocates reframed their lawsuit in New York, suing the government because Plan B is not available to children under 18 years of age.  On March 23, 2009, a federal district court in New York ruled that Plan B must be made available to 17-year-old minors and directed the FDA to reconsider its policies regarding minors’ access.  The Obama administration did not appeal and the FDA intends to comply with the ruling.

In June of this year, the FDA approved the first generic version of Plan B.  After all, isn’t it the goal of abortion advocates—ahem, like Justice Ginsberg—to make sure poor women and women in minorities don’t reproduce? 

In July, the FDA followed up by approving “Plan B One-Step.”  While Plan B in its original form required the ingestion of two pills, Plan B One-Step merely requires the ingestion of one pill.  In other words, the FDA has approved a pill that is even stronger than original Plan B—which is also available to anyone 17 years of age and over.

And the question still remains: If Plan B is stronger than regular birth control, and regular birth control is too strong to allow women (let alone minors) access without prescription… just why is it safe to allow unregulated access to Plan B?

The answer: It’s not.

Not only are the higher amounts of hormones found in Plan B (as compared to regular birth control) unsafe for over-the-counter status, but over-the-counter access has made Plan B available to a broader range of women than it was even tested upon.  The maker of Plan B has not researched what happens when adolescents take Plan B.  In addition, the maximum safe dose for levornorgestrel, the active ingredient in Plan B, and the effects of overdose have not been determined by scientific study on any age group.  And without physician oversight, women with health conditions that are at risk for serious complications following use of Plan B will have no guidance in taking the drug.  They won’t even know they shouldn’t use it.

Moreover, Plan B is used to exploit women.  A study done in Thailand, where emergency contraception has been available without prescription for almost 20 years, had the following comments: “Although many feminists believe that the morning-after pill gives them more control over their own bodies, it would seem, judging from the few studies conducted so far, that it is actually being used by men to exploit women.”  Indeed, studies revealed that men were the most frequent buyers.  Many women did not even know what they were taking; they were simply told by their partners that the pill was a health supplement.  In addition, easy access to an easily-administered drug encourages the continued exploitation of women by sexual predators.

Further, broad availability of Plan B has not reduced the number of abortions, but has led to higher rates of sexually transmitted diseases.  For example, once emergency contraception became available without prescription in the United Kingdom, use among teenage girls doubled from 1 in 12 to 1 in 5.  In fact, one study reported that 4 out of 12 women were influenced to have unprotected sex because of the easy access to emergency contraception.  In those areas with easy access to emergency contraception, the number of sexually transmitted diseases has skyrocketed.

It’s too bad that the drug manufacturer and abortion advocates didn’t spend the last 10 years investigating the safety concerns of Plan B. 

But their efforts did make one thing clear:  Their alleged concern for women and minors is mere rhetoric.  It’s really about the money.

This article was published with permission from Culture of Life Foundation. To view the original publication, see their website.

By Kellie M. Fiedorek
2009 Legal Extern
 

The President of the United States is in a unique position to profoundly influence the nation’s debates over key social and political issues for decades after he leaves office.  He can do this because he maintains the authority to appoint judges to the nation’s federal courts including the U.S. Supreme Court. 

Although these nominees – including those for federal district courts and for highly-influential federal circuit courts — must be approved by the Senate, the President bears the responsibility to nominate men and women he believes are qualified for these important positions. More often than not, he also seeks to nominate individuals that share his political and social views as well as his judicial philosophy.

The decisions of these judges impact not only the parties involved in a particular case, but also the entire judicial system and even society at large.  At the appellate level, judges’ decisions become the precedent in the particular circuit where they are decided and provide persuasive authority for other federal and state courts.  Moreover, in the Supreme Court, the Justices’ decisions set an enduring precedent – one that is not often subsequently reversed or even revisited.

The President, therefore, possesses the distinctive power to impact various legal, political, and policy debates and determinations through his judicial appointments.  Because federal judges are tenured for life, the President can leave a lasting impact on the United States and its laws long after his presidency has ended.  Consequently, it is critical to be informed about the President’s motivation and ideology and understand the types of individuals he will likely appoint and the impact they will have. 

At this critical juncture in our nation’s history, it is particularly important that Americans are prepared to articulately discuss and courageously challenge any appointee whose record reveals a failure to uphold the deepest values on which this nation was established—the equal right to life, liberty, and the pursuit of happiness of all human beings.

Several current Justices on the U.S. Supreme Court are past or nearing retirement age, and quite possibly have been waiting for a Democrat President so they can “safely” announce their retirements.  Additionally, Justice Ruth Bader Ginsburg is currently being treated for pancreatic cancer.  Thus, it is extremely likely that there will be a vacancy on the Supreme Court in the near future and that President Obama could even appoint at least one Justice as early as this summer.  

Looking at President Obama’s public statements and record thus far, it is evident that he will most likely appoint activist Justices who interpret the Constitution broadly and read their own views into the law rather than simply applying the law.  This could include reading the spirit and intent of the Freedom of Choice Act – radical federal legislation that seeks to impose unregulated, unrestricted, and taxpayer-funded abortion-on-demand on the nation and to overturn more than 500 protective state and federal laws related to abortion – into the Constitution (which, as drafted, is silent on abortion).

During his campaign, President Obama stated that he finds himself compelled “to side with Justice Breyer’s view of the Constitution –that it is not a static but rather a living document, and must be read in the context of an ever-changing world.”   A Justice’s view on how to interpret the Constitution is paramount.  The differing treatment of partial-birth abortion bans by the Rehnquist and Roberts courts, for example, reveals the importance of the Justices’ interpretative approach to the Constitution.   A Court controlled by Justices who embrace the idea of a “living Constitution” frequently find constitutional barriers to the political outcomes they dislike, while they ignore the constitutional texts that conflict with the government actions of which they approve.  While perhaps not always free from error, those Justices who embrace the textualist approach at least demonstrate a greater willingness to return difficult questions that the Constitution does not specifically address to the democratic process.

It is widely expected that President Obama will appoint U.S. Supreme Court Justices who support unfettered abortion rights and who would interpret that “right” in an increasingly unrestrained and radical manner.  During his campaign, President Obama publicly stated that he would appoint candidates in the mold of Justices Ruth Bader Ginsburg, Stephen Breyer, and David Souter, three of the Court’s most avid pro-abortion Justices who, for example, voted to strike down the federal ban on partial-birth abortion.  

Additionally, Americans should not limit their caution and attentiveness to President Obama’s potential Supreme Court nominees, but should also remain alert regarding who he nominates to the federal district and circuit courts.  Activist judges in these positions, who value their own interpretations of the law over justice and human dignity, remain equally as dangerous as those Justices appointed to the U.S. Supreme Court because decisions in the lower federal courts can have more significant and lasting impacts.  Cases appealed to the federal circuit courts seldom reach the U.S. Supreme Court, so these lower courts frequently have the final word on crucial issues.

Currently, there are 15 vacancies in the federal circuit courts — 12 geographically-based federal courts of appeal.  Their decisions cover, among other matters, abortion, civil rights, searches and seizures, age and gender discrimination, gay rights, review of federal regulations and terrorism, religious liberty, capital punishment, and corporate wrongdoing.  Many Americans are rightly concerned about the types of nominees President Obama will appoint to these courts, especially in light of the radically pro-abortion candidates he has already nominated to important positions in his Administration.

Further, President Obama has recently made several controversial nominations to three federal circuit courts.  These nominations reveal not only a shift in the federal judiciary toward Democrat control, but also a radical disregard for the principles on which this country was founded. 
   
On March 17, Obama nominated Judge David Hamilton, a federal district court judge in Indiana with an extensive pro-abortion and anti-religious freedom record, to the 7th Circuit  Hamilton – President Obama’s first judicial nominee — is the former Vice President for Litigation and a board member of the Indiana branch of the American Civil Liberties Union (ACLU) and a former fundraiser for the Association for Community Organizations for Reform Now (ACORN).  Hamilton was first appointed to the federal bench by President Bill Clinton in 1994, even though the American Bar Association (ABA) had given him a “not qualified” rating.

As a federal judge, Hamilton issued multiple rulings over seven years to prevent Indiana’s informed consent law—a law that fully complied with the U.S. Supreme Court’s requirements for such laws (as set out in the 1992 Planned Parenthood v. Casey decision)—from going into effect.  The 7th Circuit—the same court to which President Obama has nominated Hamilton—later reversed his decision, stating “[n]o court anywhere in the country (other than one district judge in Indiana [i.e., Hamilton]) has held any similar law invalid in the years since Casey.”   Hamilton ruled in another decision that the Indiana House violated the Constitution by opening its session with prayers mainly representing the Christian tradition.  He stated in his decision that “they should refrain from using Christ’s name or title,” and held that sectarian prayer at the opening of the legislatives session should be banned.

Earlier this month, President Obama nominated Judge Gerard Lynch to the 2nd Circuit and Judge Andre Davis to the 4th Circuit.  Judge Lynch was a former cooperating attorney for the ACLU and Judge Davis has a reputation for handing down rulings favoring criminal defendants.  Additionally, in two cases where African-American restaurant patrons claimed they were subjected to hostile treatment, Davis instituted a framework for evaluating such claims.  While this framework was subsequently adopted by several other federal district courts, the 4th Circuit declined to do so.  Davis’ presence on the 4th Circuit could strongly influence that court on civil rights issues, in addition to bringing a more activist approach to interpreting the law.

Clearly, Americans have reason to be concerned about President Obama’s early judicial nominations as they appear to indicate that he will appoint judicial activists with radical views on critical issues such as abortion, religious freedom, and civil rights for all Americans.

Without question, the judicial appointment process must focus on the candidate’s ability and qualifications, as well as his or her willingness to adhere to the proper role of a judge, namely, to interpret the law and properly apply it.  The only litmus test the President should be applying is that judicial nominees have significant experience in the federal judiciary and recognize the extent of their authority.  This would include an acknowledgment that the judiciary is not a means to affect policy, reconstruct laws, or express political viewpoints.  As Americans, we should insist that the President hold each potential judicial candidate to this standard so that, when the President’s time in office concludes, the lasting effects of his presidency benefit the entire country.  

This article originally appeared on the Culture of Life website. To view the article as originally published, see Culture of Life.

By Jessica Sage
AUL Staff Counsel
 

When President Obama approved federal funding for embryonic stem cell research he stated, “It is about ensuring that scientific data is never distorted or concealed to serve a political agenda — and that we make scientific decisions based on facts, not ideology.”  If this is true:  When scientific decisions involve public policy, where are the ideological and moral debates supposed to take place?  Perhaps the federal district court in NY, where one judge’s ideology and political agenda ignored scientific facts and trumped all policy considerations by directing the elimination of age restrictions on the over-the-counter (OTC) use of Plan B “emergency contraception” and by requiring no physician or parental involvement for minors.

Two weeks ago, in Tummino v. Torti, No. 05-CV-366 (E.D.NY. Mar. 23, 2009), the judge ordered the federal Food and Drug Administration (FDA) to reconsider its denial of a citizen petition to approve Plan B for OTC status without age restrictions and further declared that “no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription.”  He further directed compliance of this OTC availability to 17 year olds within 30 days.

Case Background & History

 

The FDA approved prescription-only use of Plan B in the U.S. in 1999 and currently it is the only so-called “emergency contraceptive” drug sold in the U.S.  In 2001, the FDA received a citizen petition from the Center for Reproductive Rights (CRR), representing numerous family planning and health organizations.  CRR is an organization that advances reproductive freedom as a fundamental right and hopes to see all governments legally obligated to protect, respect, and fulfill this “right” through – among other measures – mandated access and funding of contraception.  Their request:  To switch Plan B from prescription to OTC without age restrictions. 

The FDA has approved no other hormonal contraceptive to be used without a prescription and physician’s oversight.  CRR’s clear political and ideological agenda advocated for broader distribution and unrestricted access to “emergency contraceptives” for women and young girls of all ages regardless of the evident safety and policy concerns over Plan B.

The FDA deferred its response to the citizen petition because the supporting information was insufficient to make the OTC switch for all ages.  The FDA awaited the drug sponsor, Barr Pharmaceuticals (Barr), to conduct the necessary pediatric studies.  But rather then conduct the studies, Barr simply amended its application to seek OTC approval for women 17 years and older.

In the meantime, CRR and fellow family planning advocates filed this lawsuit against the FDA.  Later, the FDA denied CRR’s petition (in June 2006) for its insufficiency of data.  However, by August 2006, the FDA approved Barr’s OTC application for women 18 years of age and older.   The then- acting FDA Commissioner documented that its approval for 18 versus 17 year olds was based on the states’ ability to enforce the age restriction and the lack of evidence that 17 year olds can self-medicate safely.

In Tummino v. Torti, the federal district court judge disagreed with the FDA’s age restriction and ordered the FDA to make Plan B OTC accessible to 17 year olds within 30 days and to reconsider approving it for women of all ages.

Issues and Concerns Raised by District Court’s Decision

 

The district court’s decision ignored or failed to adequately address a number of significant concerns:

There is No Meaningful Distinction between Prescription and OTC Plan B

 

In his opinion, the judge failed to address the legality and concern of the FDA approving prescription and OTC Plan B without distinction in the drug or the labeling—an unprecedented FDA approval of dual marketing for which the FDA sought public comment.

In their public comment to the FDA, Concerned Women of America (CWA), the Family Research Council (FRC), the Christian Medical and Dental Associations (CMDA), and the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) argued that dual marketing causes confusion between the drug products, that the FDA lacked authority and infrastructure to enforce an age restriction distinction between prescription and OTC, and that it remains unproven that Plan B can be used safely without physician involvement.

Historically, the FDA interprets applicable regulations to require a “meaningful difference” between a drug that is prescription and one available OTC.   Five parameters are considered to deem a difference meaningful—the product’s active ingredient, indication, strength, route of administration, or dosage form.  A subpopulation, related to age, has never been found to be a parameter permitting a dual drug status.

The judge failed to acknowledge any difference, meaningful or otherwise, between the prescription and OTC Plan B drugs.  In addition, he required no difference in the labeling to distinguish between a prescribed Plan B and one purchased OTC.

FDA Lacks Enforcement Mechanism for Age Restrictions

 

The judge failed to address the FDA’s inability to enforce an age restriction on OTC access of Plan B.  The FDA has no statutory authority, much less the economic or personnel resources, to enforce the court-dictated OTC Plan B sales—leaving the enforcement activities to the states, local governments, or pharmacies.  Neither the FDA, nor the judge, gave any instructions to these third parties, leaving enforcement unchecked and inconsistent throughout the U.S.

Further evidence, revealed during the public comments on the dual status of prescription and OTC Plan B, demonstrated that efforts to restrict consumer access to certain nonprescription drugs proved to be ineffective.  For example, using their controlled substances laws in an attempt to prevent abuse of certain medications, some states have restricted access to cold medicines with codeine and required them to be behind the counter (BTC) with a pharmacist.  But many states found the restrictions did not achieve their intended purpose and roughly half of the states abandoned the restricted access by changing the drug status to prescription-only.

Plan B is Not Safe for Self-Administration Particularly by 12-16 year olds

 

The judge ordered the FDA to reconsider its decision requiring a prescription for Plan B for women under 17 despite the noted lack of evidence that it can be safely self-administrated by this vulnerable age group.

By regulation, the FDA deems a drug suitable for OTC use: (1) when it is found to be safe and effective for self-administration; and (2) when the labeling provides clear directions for safe use and warnings of misuse, side effects and adverse reactions.  When a drug is intended for pediatric use, regulation necessitates that the FDA receive adequate data to assess the safety and effectiveness, and to support dosing in pediatric subpopulations.

Given that all other hormone-based contraceptives require prescriptions and physician oversight for women of all ages, the FDA proceeded with warranted caution in initially approving Plan B for age-restricted OTC access. According to its letter denying the CRR’s 2001 petition, the FDA noted these unanswered questions:

• Could consumers of all ages – particularly sexually active girls under 18 – use Plan B within the proper time intervals without the assistance of a health care practitioner?
• Would consumers who are already pregnant use Plan B?
• Would consumers of all ages know what to do if they had an adverse reaction or developed unexpected vaginal bleeding prior to or after using Plan B?
• What changes in sexual contraceptive behaviors result from Plan B use?
• What are the rates of unintended pregnancies and STDs associated with Plan B use?
• Are there any safety or efficacy concerns associated with repeated use of Plan B?

The FDA concluded that there was insufficient evidence that 17 year olds could safely use Plan B OTC.  More specifically, the Plan B OTC Label Comprehension Study revealed significant discrepancies in young users’ ability to self-medicate.  An alarming 33 percent of participating women understood that Plan B could be used as a regular contraceptive.  In the case of unexplained vaginal bleeding, 25 percent of women did not understand that Plan B should not be used while 19 percent of women did not understand that they should seek medical care if severe abdominal pain developed.  The FDA further concluded it was inappropriate to use data from women 17 years of age and older to extrapolate the probable use behaviors of younger girls.

The district court disregarded these safety concerns and controversial societal perspectives of Plan B.  It did not rely on science, but rather it relied on certain ideological opinions in the record—believing access to Plan B was more important than ensuring its safe use. 

 

Plan B’s Unproven Safety Record

 

The district court dismissed the risks involved in taking Plan B, particularly when administered without physician counseling and oversight.  There are significant health risks inherent in the use of Plan B including serious drug interactions, increases in known risks such as ectopic pregnancy, and unknown consequences from patient’s non-compliance with drug instructions and warnings.

First, Plan B can interact with other drugs and may lead to serious and dangerous drug interactions.  Drugs which may interact negatively with Plan B include drugs used in therapies to treat HIV-1, tuberculosis, and mild to moderate depression—diseases that affect more than 20 million people nationwide.

Second, no distinction has been made between the risks for other hormonal oral contraceptives and Plan B.  According to label warnings, progestin-only oral contraceptives are associated with ectopic pregnancies, delayed follicular atresia, irregular genital bleeding, and cancer of the breasts and reproductive organs. 

Other oral contraceptives with the same active ingredient—but a lower dosage—warn not to use the drug with known or suspected pregnancy, known or suspected breast cancer, or undiagnosed vaginal bleeding.  It is recommended that patients be counseled and examined by a physician before using oral contraception.

Third, AAPLOG has expressed great concern over the increased risk of ectopic pregnancy associated with of the use of Plan B and other “emergency contraceptives.”  In 2003, the United Kingdom’s (UK) Department of Health alerted British doctors to possible risk of ectopic pregnancy associated with “emergency contraceptive” use.  Evidence had revealed a 6% rate of ectopic pregnancy (or 12 in 201 cases) when “emergency contraceptives” failed — three times the expected rate of ectopic pregnancy.  Notably, no one has presented evidence to alleviate AAPLOG’s concern.

Further, the Plan B OTC Label Comprehension Study revealed that approximately 20 percent of women—in a clinical study, not actual use—did not understand they should seek medical attention if severe abdominal pain develops after using Plan B, a symptom of possible ectopic pregnancy.  The lack of physician involvement elevates the risk of women misdiagnosing the signs of an ectopic pregnancy, which without early detection can result in significant harm and possibly death for a woman taking Plan B.

Fourth, there has been little discussion of patient compliance or lack thereof.  The potential for repeated and frequent use of Plan B creates unknown risks.  The FDA does not have data on the likely abuse of Plan B as a form of regular contraception.  The Plan B labeling does not provide information as to how often or how long to wait before repeating use of the recommended dosage.

There is no evidence to suggest OTC Plan B encourages consultation with a physician or results in a woman seeking the use of regular contraception—in fact, the evidence strongly suggests otherwise.  These realities combined with the inherent health risks of taking Plan B leaves women’s health unnecessarily compromised.

Plan B Has Been Shown to Increase Rates of Sexually Transmitted Disease

 

The district court did not address the increased rates of sexually transmitted diseases (STDs) among women who use “emergency contraceptive” including Plan B.  Rather, it simply referenced one doctor’s opinion that frequency of STDS remained consistent across studies and ages – inexplicably ignoring the fact that the rates were consistently higher with “emergency contraceptives” use. 

CWA has received numerous comments from physicians articulating the dangers of this OTC policy for Plan B.  Their experience reveals that when women are able to receive contraception without seeing a healthcare professional, they are typically ignorant of STDS and the long-term risks and complications associated with and will remain ignorant of this important information.

Studies in the UK and elsewhere strongly indicate an increase in STDs among “emergency contraceptives” users.  In 2000, the UK made a highly-controversial decision to make ”emergency contraceptives” available directly from pharmacies to women over the age of 16.  Five years after initiating this “experiment,” one report detailed a 76 percent increase in chlamydia, a 55 percent increase in gonorrhea, a 54 percent increase in syphilis, and a 20 percent increase in genital warts.  For all of these infections, the highest rates and the fastest increases were found among women ages 16-24.”[1]

In Scotland between 1998 and 2004, rates of chlamydia rose by 106 percent.  Scottish executive figures reveal almost half of all chlamydia cases diagnosed in 2002 were in people under 25 years of age and that there had been a 66 percent increase in cases involving those under 16.

A Swedish study published in 2002 reported that “[STDs] were on the rise among adolescents who had OTC access to [”emergency contraceptives”] and other forms of contraception.”[2]  More specifically, genital chlamydial infections increased from 14,000 cases in 1994 to 22,263 cases in 2001, with the most drastic increase among teenagers.[3]

AAPLOG notes the most common reason young women visit a physician is to obtain contraception and that it is in a physician-patient environment where these women can receive proper counseling, early detection of STDs, and make their best decisions regarding family planning.  In addition, the American Academy of Pediatrics’ (AAP) recommends that teens receiving “emergency contraceptives” by a telephone consult should follow-up with an appointment to determine if a pregnancy exists and to be screened for STDs.

These striking increases in STD rates among OTC “emergency contraceptive” users should negate any attempts to make Plan B available OTC to young American women and should instead mandate physician involvement through prescription-only access.

 

Plan B Has Not Been Shown to Reduce Unwanted Pregnancy and Subsequent Abortions

 

The district court failed to acknowledge that overwhelming evidence has demonstrated that OTC access to “emergency contraceptives” has failed to reduce rates of unwanted pregnancy and abortion.  Instead, the district court clearly shared CRR’s “fear” that a delay in access—by physician prescription or point-of-sale restrictions—to Plan B would render the drug ineffective and increase the chance of unwanted pregnancy.  Yet, studies clearly show that Plan B does not produce “as advertised” results even when provided to woman in advance.

American research conducted in 2005 (and reported in the Journal of the American Medical Association) failed to support the contention that OTC marketing of Plan B would decrease the number of unintended pregnancies.  Specifically, a study of 2,117 young women ages 15-24 showed that providing OTC access to EC did not result in any decrease in the pregnancy rate.[4]

On her webpage for Reproductive and Developmental Sciences, Professor Anna Glasier, concedes, “[my] research has led to the conclusion that the widespread use of [“emergency contraceptives”] will not reduce unintended pregnancy rates.”  She further says the “obsession with [“emergency contraceptives”] as a public health measure to reduce abortion rates” is a distraction from other measures.  Her conclusions are supported by the demonstrable rise in UK abortion rates despite the increased availability and use of “emergency contraceptives.”

In the UK, “emergency contraceptive” use has increased from one percent in 1984 to twelve percent in 2002.  Yet, abortion rates rose from 11 percent in 1984 to 17.8 percent in 2004.

Additionally, Anna Glasier details similar observations in Sweden—increased use of ”emergency contraceptives” does not decrease rate of abortions –  and notes that ten studies in numerous countries—which provided women a supply of “emergency contraceptives” in advance—resulted in an increased use of the drugs by two- to three- fold but had no measurable effect on pregnancy or abortion rates.

More alarmingly, these increases are observable within the teenage population.  A 2005 article in the UK Observer noted that, since the introduction of non-prescription “emergency contraceptives” (in 2000), local authorities had noted an increase in the already high rates of teenage pregnancies.

Related Concerns over Risky Sexual Behavior

 

The district court minimized any concern that OTC access to “emergency contraceptives” may lead to increased risky sexual behavior, reasoning that “[w]hile it may have been rational for the FDA to consider adolescent cognitive development in its evaluation of Plan B as an OTC drug…the FDA’s focus on these behavioral concerns [i.e. increases in promiscuous and unsafe sexual behavior] stemmed from political pressure rather than permissible health and safety concerns.”    Political pressure—in the court’s opinion—was the only reason the Center for Drug Evaluation and Research (CDER) concluded, as a scientific matter, that Plan B was not safe for OTC use by those under 17.

In the FDA’s letter denying CRR’s 2001 petition, the FDA recognized that teenagers’ sexual behavior is different from that of older women, specifically referencing the CDER studies and findings:

Young adolescence is characterized by more impulsive behavior that is less controlled by balancing risks and benefits. These characteristics may impact decision-making regarding birth control. Risks from inappropriate use of Plan B include: failure to understand that the product is for non-routine use, and routine use would result in a higher than appropriate dose of systemically-absorbed hormone product with possible serious side-effects; failure to understand that Plan B is not a substitute for other forms of birth control that offer protection against sexually transmitted diseases including HIV; and failure to understand the required dosing regimen for Plan B.

Disregarding these important findings as well as increases rates of STDs, unwanted pregnancies, and abortions among “emergency contraceptive” users, the judge inexplicably opined that the FDA inadequately defended the limitations it had placed on Plan B access.

Potential Exposure to Sexual Exploitation and Abuse

 

In light of the district court’s ruling, will men be increasingly able to exploit minor girls—or even women in general—when Plan B is made accessible to them?  Yet another concern not addressed by the district court is the access men have to Plan B as an OTC drug.  A very plausible outcome of OTC access to Plan B is an increased use of “emergency contraceptives” by sexual perpetrators to hide their crimes and facilitate the sexual abuse of young girls.

Many have expressed concern over older friends, boyfriends, relatives or others coercing young woman into taking ”emergency contraceptives” or giving it to them under false pretenses (i.e. slipping it unknowingly into a drink or misrepresenting it as a multivitamin).  These concerns may seem far-fetched, but evidence from places like India suggests that making Plan B available OTC would serve to further predatory interests of sexual offenders.

FDA Should Factor Public Policy Goals into Its Decisions

The district court failed to acknowledge that the FDA can and does consider public policy and public morality in its decision-making process.  The FDA’s jurisdiction over the “safety and efficacy” of drugs provides it with legal authority to consider morality, misuse, age-appropriate sexual behavior, and related social issues in its approval process.  It is particularly appropriate when considering the risk/benefit analysis or the safety/efficacy profile of a drug such as Plan B.  

Courts typically give deference to the experience and expertise of the FDA.  When approaching an approval decision, the FDA necessarily takes into account evidence that the targeted patient population is likely to use the drug in a way that reduces its safety, impacts the patient’s health negatively, or increases the risk portion of the risk/benefit analysis. 

In this particular case, the FDA expressed science-backed policy and moral considerations throughout the Plan B OTC approval process, but the district court made an unprecedented decision to overrule the FDA’s discretion and insert his and CRR’s ideology.

Potential Impact of the Decision

 

One district court judge in NY orders the FDA to make Plan B available OTC to 17 year olds and to reconsider making Plan B available OTC to women of all ages.  The impact of this decision could be extensive and damaging.

First, it puts women’s health at risk.  The FDA may “over comply” with the court’s ruling.  It may actually grant the wishes of CRR and family planning advocates to make Plan B accessible OTC for women—and subsequently men—of all ages. 

Second, the ruling sets a precedent for other hormone-based birth control pills to be available OTC since the active ingredient in Plan B is the same as other progesterone-only pills—only at a higher dosage.  It also acts as a solicitation for anyone to file a citizen petition for an OTC switch of other prescription-only contraceptives.

Third, this successful lawsuit likely opens the FDA’s drug approval process to a vast number of future challenges.  The court recognized that any district court may hear a FDA challenge by nearly any interested party.  This case sets a very low threshold for standing and practically renders the FDA drug approval process vulnerable to anyone who may disagree with its policy and risk/benefit analysis. 

Possible State Legislative Responses

 

If the FDA approves Plan B for all ages, what can states do to limit its harmful effects?  State lawmakers may consider creating a behind-the-counter (BTC) system for Plan B.  A BTC system would: (1) ensure women receive pharmacist counseling before purchase; (2) permit only the ultimate Plan B user to purchase it—effectually prohibiting men from directly purchasing the drug; (3) allow for restrictions on the number of times Plan B may be purchased within a certain period of time; and (4) prohibit purchase by sex offenders.

Conclusion

 

Plan B is not good for women’s health and should require a prescription with physician counseling, particularly when it involves young women.  The resonating question:  How can you isolate public policy decisions involving science from the public debate of what is right for America and her young women?  Unfortunately, President Obama’s segregation of science from ideology and morality is unrealistic when it involves issues of public policy.  Rather, it is a question of whose ideology and morality will guide our scientific discovery and application.  In this particular case, CRR selected a venue with a district court judge who obviously shared its ideology—one that increases the market share for contraception and abortions, epitomizes the right to sex without consequence, and unnecessarily increases the risk to women’s health.

[1] Geraldine Bedell, Waking up to the Morning After Pill, The Observer, May 15, 2005, available at http://observer.guardian.co.uk/magazine/story/0,11913,1482669,00.html (last visited April 7, 2009).

[2] January W. Payne, Is Plan B Unsafe?  Current Research Does Not Support Fears of Day-After Pill Dangers, Washington Post, September 6, 2005, at HE01.

[3] K. Edgardh, Adolescent Sexual Health in Sweden, Sexually Transmitted Infections, 2002, 78: 352-356.

[4] See Raine, TR, et al, Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs, JAMA 2005, 293:54-62, at www.jama.com.27 (last visited April 7, 2009).

By Denise M. Burke
AUL Vice President of Legal Affairs
 

*This is an updated version of a previously posted article.

Over the past six months, abortion advocates and their allies have begun insisting in the media and in communications with supporters that the “Freedom of Choice Act” (FOCA), while “important,” is not an immediate priority and that concerned Americans have overreacted to a piece of legislation that has not even been introduced in the current Congress.  And despite having control of Congress and the Executive Branch, some have even appeared to confess they do not have the support needed for passage.

What are the reasons for this sudden and very public change of tune?  Why—when they have President Obama’s promise to finally enact FOCA, 20 years after it was first proposed—do they appear to be quickly conceding defeat?

This apparent back-pedaling on a long-established priority is a testament to the ferocious opposition engendered by this radical federal power-grab masquerading as common legislation.  However, as history repeatedly shows, abortion advocates’ apparent concessions should be viewed with a great deal of skepticism.  Now more than ever we need to beware of “FOCA-by-Stealth”: attempts by the Administration, Congress, and abortion advocates to enact FOCA piecemeal while purposefully attempting to deflect—or at least neutralize—public opposition to their far-reaching abortion-on-demand agenda.

The Administration and abortion advocates have stolen a page from the successful pro-life playbook of incremental strategy.  However, instead of targeted laws designed to fence in the abortion license and to protect women from the negative impact of abortion, they are using a variety of executive, budgetary, and legislative means to realize their “full vision of reproductive freedom” —code words for unrestricted, unregulated, unapologetic, and taxpayer-funded abortion-on-demand.

Recognizing an Ally, Abortion Advocates Waste No Time Making Demands

In December 2008 (just one month after the election), a coalition of pro-abortion groups—including Planned Parenthood, NARAL Pro-Choice America, and the American Civil Liberties Union (ACLU)—gave an expansive set of “marching orders” to the Obama Administration.  In a 55-page memorandum subsequently posted on the Obama Transition Team’s website, the coalition urged the incoming Administration to, among other things:

• Rescind the Mexico City Policy first implemented by President Ronald Reagan in 1984 to prohibit federal taxpayer funding of programs and organizations that promote or perform abortions overseas.
• Restore federal taxpayer funding for the United Nations Population Fund (UNFPA), which actively promotes abortion worldwide and is arguably complicit in the continued enforcement of restrictive population control programs and forced abortions.
• Remove U.S. Food and Drug Administration (FDA) restrictions on minors’ access to over-the-counter “emergency contraceptives” (also known as Plan B).  Then-existing FDA protocols required girls under 18 years of age to have a valid prescription for this potentially-dangerous drug.
• Reverse the December 2008 decision by the Department of Health and Human Services (HHS) requiring recipients of certain federal funding certify compliance with existing federal laws protecting healthcare professionals who are morally opposed to promoting or providing abortions or contraceptives.
• Appoint federal judges—including US Supreme Court justices—who support abortion rights and would interpret that “right” in an increasingly expansive and radical manner.
• Increase Title X family planning funding, which provides funding to Planned Parenthood, from $300 million in fiscal year 2009 to at least $700 million in 2010.
• Repeal the Hyde Amendment, which limits federal taxpayer funding for abortions for Medicaid-eligible women.
• Provide federal taxpayer funding of abortions for federal employees and their dependents, members of the Armed Forces and their dependents, residents of the District of Columbia, Peace Corps volunteers, Native American women, and women in federal prisons.
• Increase federal funding of international family planning programs from $461 million in fiscal year 2009 to $1 billion for 2010.

Finally and predictably, the document also specifically called on President Obama to take the lead in calling for Congress to pass the “Freedom of Choice Act” and—as he has already promised—sign it into law once it arrives at his desk.
Each of the demands listed above—and others contained in this controversial and extensive wish list—embody the spirit of FOCA and represent incremental but critical steps toward implementing its radical agenda.  Sadly, the Obama Administration and its allies in Congress have acted quickly to meet and even exceed the demands of abortion activists.  In just its first six months, the new Administration has met many of these demands and already earnestly begun action on the remainder.

How Is FOCA’s Expansive and Radical Agenda Being Implemented?

Despite the increasing backlash against both FOCA and the Administration’s apparent desire to centralize power and authority in the federal government at the expense of the States and the people, abortion advocates within and outside the Administration have not been dissuaded from their goal of unfettered, federal government-controlled, and taxpayer-funded abortion-on-demand.  Instead, they are clearly determined to pursue what they believe is the path of least resistance: FOCA-by-Stealth.

Rather than a direct and possibly losing battle and debate over FOCA as a whole, they are resorting to a strategy of incremental and relentless implementation of the principles, spirit, and intent of FOCA.  In pursuit of this strategy, they are already using a variety of tools including Executive Orders; Executive Branch appointments; federal budget appropriations; federal legislation; action on long-standing budgetary riders; efforts to overhaul the nation’s healthcare system; and even potential Senate ratification of international conventions to advance and fund a radical pro-abortion agenda.

Executive Orders

American Presidents have issued Executive Orders since 1789; most of these orders have set the policies of executive departments or otherwise directed the activities of Executive Branch officials.  Because they are an efficient and effective means for the Administration to unilaterally further its policy goals, Executive Orders have often been controversial.  Only days into his term, President Obama made use of an Executive Order to further FOCA-by-Stealth.

On January 23, 2009—just three days after his inauguration—President Obama signed an Executive Order to repeal the Mexico City Policy prohibiting U.S. taxpayer funding of international family planning programs that promote and perform abortions overseas.  Among the groups denied funding under this former policy was the International Planned Parenthood Federation (IPPF), the parent organization of the Planned Parenthood Federation of America (more commonly known as “Planned Parenthood”).

In a statement released the next day, President Obama blithely ignored the mounting evidence of abortion’s negative impact on women and the fact that this funding is often used by groups such as IPPF to force abortion on unwilling nations and cultures.  Instead, he couched his action in terms of its potential economic impact and his desire to end the “culture war” over abortion, stating:

It is right for us to rescind this policy and restore critical efforts to protect and empower women and promote global economic development.  For too long, international family planning assistance has been used as a political wedge issue, the subject of a back and forth debate that has served only to divide us.  I have no desire to continue this stale and fruitless debate.

This statement is eerily reminiscent of then-Presidential candidate Obama’s speech to the Planned Parenthood Action Fund in July 2007, when he told cheering abortion supporters he remains “absolutely convinced that culture wars are so nineties,” and it is “time to turn the page” since he and other abortion supporters are “tired about arguing about the same ole’ stuff.”

Not coincidentally, in this same speech he also promised “[o]n this fundamental issue [abortion], I will not yield,” and the “first thing” he would do as President was “sign the ‘Freedom of Choice Act’.”

Presidents also often use Executive Orders to appoint or create various groups to advise them on certain policy decisions.  In this vein, on March 11, 2009, President Obama established a new “White House Council on Women and Girls” to “provide a coordinated federal response to the challenges confronted by women and girls and to ensure that all Cabinet and Cabinet-level agencies consider how their policies and programs impact women and families.”  Among its priorities is to “improve women’s health care.”  Given that the Council’s Executive Director is Tina Tchen, former vice-president of the pro-abortion National Organization for Women (NOW), it is safe to assume that the Council’s vision of women’s healthcare will undoubtedly include unfettered access to abortion-on-demand.

Executive Appointments

The President has the responsibility to make a wide range of executive appointments, including Cabinet members, ambassadors, and other Executive Branch officials.  These individuals are charged with implementing the President’s policies on a variety of topics, including abortion and important civil rights such as healthcare freedom of conscience.

Among the appointed positions with a direct impact on abortion-related policies are the Secretary of U.S. Department of Health and Human Services (HHS), the Commissioner of the federal Food and Drug Administration (FDA), and the U.S. Surgeon General. 
On March 1, 2009, President Obama nominated pro-abortion Kansas Governor Kathleen Sebilius to serve as Secretary of HHS.  Confirmed on April 28, 2009, she is now in a position to profoundly influence American healthcare—including federal and state policies regarding abortion, healthcare rights of conscience, bioethics and biotechnologies, and end-of-life issues.
As HHS Secretary, Sebelius will make important policy determinations including:

• Whether to rescind, modify, or retain HHS rules requiring recipients of HHS funding to certify their compliance with existing federal laws protecting healthcare freedom of conscience.  In March 2009, HHS announced its intent to rescind these protective rules and requested public comment on the rules and their implications.
• Whether to rescind approval for or, at a minimum, review the safety and efficacy of RU-486 (“the abortion pill”), which has killed at least 7 women in the U.S. since it was approved by the FDA in September 2000.
• Whether to actively promote further federal funding of abortion-on-demand and contraceptives (including Plan B) as a component of “healthcare reform.”

Sadly, Secretary Sebelius’s extensive public record demonstrates she is an ardent supporter of abortion-on-demand and gives strong indications that she will continue to implement and follow strongly pro-abortion policies during her tenure as HHS Secretary.
In the 1980s and 1990s then-State Representative Sebelius voted to weaken or eliminate even such modest abortion-related measures as parental notification, reflection periods, and informed consent— under U.S. Supreme Court jurisprudence, these are all constitutional measures.
However, her record as Governor of Kansas was—in substantial part—even more extreme in its support for abortion.  She routinely opposed or vetoed abortion-accountability bills, including medically-supported clinic regulation legislation which she vetoed in both 2003 and 2005.  The need for this critical legislation was predicated, in large part, on evidence of shocking conditions in Kansas abortion clinics.  For example, two inspections of the same Topeka abortion clinic discovered fetal remains stored in the same refrigerator as food; a dead rodent in the clinic hallway; overflowing, uncovered disposal bins containing medical waste; unlabeled, pre-drawn syringes with controlled substances in an unlocked refrigerator; improperly labeled and expired medicines; a carpeted floor in a surgical procedure room; and visible dirt and general disarray throughout the clinic. Dr. Krishna Rajanna, who operated the unsafe and unsanitary clinic, also consistently violated practice guidelines for conscious sedation.
In 2008, she vetoed a measure that would have strengthened the state’s existing parental notification law by 1) requiring any adult accompanying a minor show identification, declare in writing his/her relationship to the minor, and identify the putative father of the unborn child; 2) requiring the minor to show some form of photo identification proving identity and place of residence; and 3) if the minor chooses to seek a judicial waiver of the law’s requirements, prohibiting any employee of an abortion provider or clinic from assisting her with the requisite court filings and proceedings.
More shocking is her continuing and unyielding support for late-term abortions, including post-viability abortions.  Between 2006 and 2009, she vetoed measures:

• Requiring explicit and medically-supported reasons for late-term abortions;
• Requiring abortion providers to report the diagnosis or the nature of the condition which necessitated a post-viability abortion;
• Permitting injunctive relief for either a completed or about-to-be-performed illegal late-term abortion; and
• Adding certain prosecutors (in addition to the Attorney General) to investigate and pursue violations of existing restrictions on late-term abortions.

As Governor of Kansas, Secretary Sebelius  also appointed radical abortion supporters to important state positions.  For example, she appointed a former abortion clinic “escort” John Carmichael to the state Human Rights Commission;  however, his name was quietly withdrawn ten months later in May 2008.
She further appointed political supporter and abortionist Howard Ellis to serve on the Kansas State Board of Healing Arts after he surrendered his medical license in Missouri rather than face disciplinary charges.  Ellis resigned under pressure, and two months later he was charged by the Board with attempting to persuade a physician to falsify records.
Unfortunately, Secretary Sebelius is not the only abortion-supporter that President Obama has appointed to an important healthcare policy position within his Administration.
On March 14, 2009, President Obama nominated former New York City health commissioner, Dr. Margaret Hamburg, to head the federal Food and Drug Administration (FDA).  The FDA is “responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”  It “is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
In direct contradiction of these mandates, one of Dr. Hamburg’s first decisions as FDA Commissioner was to forego an appeal of an adverse decision in Tummino v. Torti, a case in which a federal judge ruled that the FDA must make Plan B (or so-called “emergency contraception”) available over-the-counter to girls under the age of 18, despite a utter lack of evidence showing that the drug is safe for use by minors.
Moreover, in the current Administration, even the Secretary of State is expected to use her office to promote abortion-on-demand.  In the face of increasing threats to U.S. security, Secretary of State Hillary Clinton has inexplicably promised that promoting “reproductive rights” (i.e., abortion-on-demand) will be at the top of the Administration’s international agenda.  On March 30, 2009, Secretary Clinton received Planned Parenthood’s Margaret Sanger Award, named for the organization’s founder, an avowed proponent of race-based eugenics.  In her acceptance speech, Secretary Clinton stated, “reproductive rights . . . will be a key to the foreign policy of the United States” during the Obama Administration and that she was proud President Obama had already repealed the Mexico City Policy.  She also opined that Planned Parenthood is “one of the great exports that America has” and she looks forward to partnering with Planned Parenthood in effectuating President Obama’s foreign policy.
Under President Obama and Secretary Clinton, prominent abortion advocates have been appointed to critical State Department positions. For example, on March 6, 2009, President Obama and Secretary Clinton announced that Melanie Verveer would act as “Ambassador at large for global women’s issues.”  Verveer is the co-founder of Vital Voices, a pro-abortion international women’s organization. 
Further, Harold Koh, the President’s Legal Advisor to the State Department, has long advocated the ratification of the U.N. Convention on the Elimination of Discrimination against Women (CEDAW), an international convention that has been used to force unwilling nations – principally in the developing world – to sanction or embrace abortion-on-demand or face international sanctions or other negative consequences.  Notably, Koh, a former Dean of Yale Law School, is also considered by many as a possible future U.S. Supreme Court nominee.
Department of Justice Appointments

The U.S. Department of Justice (DOJ) is charged with enforcing federal law and ensuring the fair and impartial administration of justice for all Americans.  To effectuate these important tasks, the President appoints the U.S. Attorney General and other senior officials at DOJ, including the Solicitor General and the head of the DOJ’s Office of Legal Counsel.

Importantly, the Solicitor General conducts all litigation on behalf of the United States before the U.S. Supreme Court (USSC) and supervises other federal appellate court litigation directly implicating the interests of the Administration and the American people.  In doing so, the Solicitor General routinely files briefs and presents oral argument in important cases before the USSC, including those involving the constitutionality of abortion-related restrictions and regulations.  Thus, the Solicitor General is in a unique position to support or oppose such restrictions and regulations and to influence the way the USSC views such laws.

Prior to his inauguration, on January 5, 2009, then-President-elect Obama nominated Elena Kagan, then-Dean of Harvard Law School, to serve as Solicitor General.  She was confirmed by the Senate on March 19, 2009.  Ironically, Solicitor General Kagan, by her own admission, has very little litigation experience, but she is a strong abortion rights advocate who, for example, supports the use of taxpayer funding to pay for abortions.

Later, on March 11, 2009, President Obama nominated David Ogden as Deputy Attorney General, essentially Solicitor General’s Kagan’s second-in-command.  Notably, in 1992, Ogden filed an amicus brief on behalf of the American Psychological Association in the landmark abortion case Planned Parenthood v. Casey which was dismissive of abortion’s damaging effects on the psychiatric health of women.

However, President Obama’s selection to head the Office of Legal Counsel (OLC) is even more troubling.  According to DOJ’s website, the OLC:

[P]rovides authoritative legal advice to the President and all the Executive Branch agencies.  The Office drafts legal opinions of the Attorney General and also provides its own written opinions and oral advice in response to requests from the Counsel to the President, the various agencies of the Executive Branch, and offices within the Department . . . The Office also is responsible for providing legal advice to the Executive Branch on all constitutional questions and reviewing pending legislation for constitutionality.

Given their sweeping and critical responsibilities, the head and staff of OLC are supposed to be apolitical and academically disciplined.

 

President Obama has nominated Dawn Johnsen, a professor of constitutional law from the Maurer School of Law at Indiana University, to serve as the head of OLC.  Prior to her academic career, Johnsen served as a staff counsel fellow with the American Civil Liberties Union (ACLU) and then for five years with the National Abortion Rights Action League (NARAL).
In 1989, as the legal director of NARAL, Johnsen filed an amicus brief in the USSC case, Webster v. Reproductive Health Services, a constitutional challenge to a Missouri law that restricted the use of state taxpayer funds and other state resources for abortions.

In her brief, Johnsen argued that any restrictions making abortion less accessible are tantamount to “involuntary servitude” because they require “a woman to provide continuous physical service to the fetus in order to further the state’s asserted interest [in the life of the unborn.]”  She continued that, in effect, a woman “is constantly aware for nine months that her body is not her own: the state has conscripted her body for its own ends.”  Such “forced pregnancy,” she contended, reduces women to “fetal containers” and violates the Thirteenth Amendment prohibiting slavery.  Fortunately, the USSC gave no credence to these radical and ridiculous arguments.

In 2005, then-Senator Hillary Clinton (D-NY), an avowed abortion supporter, gave a speech calling for policy changes so abortion “[did] not ever have to be exercised or only in very rare circumstances.”  In response, Johnsen alleged that Senator Clinton had taken a “step in the wrong direction” by arguing for such policies.  Instead, Johnsen believes “[p]rogressives must not portray all abortions as tragedies.”

Further, despite USSC decisions upholding the constitutionality of informed consent laws with 24-hour reflection periods, parental involvement laws, and bans on partial-birth abortion, Johnsen opposes them and continues to argue they are not constitutionally permissible.  For example, in a 2006 op-ed opposing Justice Samuel Alito’s confirmation, she argued that opposition to all restrictions on abortion—not just acceptance of Roe v. Wade—should be a litmus test for judicial nominees.  To Johnson, “[t]he notion of legal restrictions as some kind of reasonable ‘compromise’—perhaps to help make abortion ‘safe, legal, and rare’… proves nonsensical.”

Critically, Solicitor General Kagan and Johnsen – if ultimately confirmed by the Senate – will be in positions to argue against the constitutionality of laws regulating or restricting abortion—including those laws the USSC has previously determined to be constitutional and which are supported by a majority of Americans—and to negatively influence the actions and positions of the White House and other Executive Branch departments.

Judicial Appointments

The President has a unique opportunity to influence a variety of legal and policy debates and decisions through his judicial appointments.  He appoints all federal district court and appellate judges, including USSC justices.  By virtue of the lifetime tenure of federal judges, the President can exert this influence long after he leaves office.

For this reason and others, a candidate’s judicial philosophy is typically of significant interest during a Presidential campaign.  During his campaign, President Obama publicly stated he would appoint USSC justices in the mold of Justices Ruth Bader Ginsburg and David Souter, two of the Court’s most ardent abortion rights supporters who, for example, voted to strike down the federal ban on partial-birth abortion.  President Obama further opined he finds himself compelled “to side with Justice Breyer’s view of the Constitution—that it is not a static but rather a living document, and must be read in the context of an ever-changing world.”

True to his expressed intent to appoint pro-abortion judges who will interpret the American Constitution in light of ever-evolving circumstances and principles rather than the original intent of the Framers, President Obama used his first judicial appointment to select a radically pro-abortion judge for the U.S. Court of Appeals for the 7th Circuit.  On March 17, 2009, the President nominated David Hamilton, a federal district court judge from Indiana, as well as a former Vice President for Litigation and board member of the Indiana branch of the ACLU and a former fundraiser for Association for Community Organizations for Reform Now (ACORN).  Hamilton was first appointed to the federal bench by President Bill Clinton in 1994 even though the American Bar Association (ABA) had given him a “not qualified” rating.

As a federal judge, Hamilton issued multiple rulings over seven years preventing Indiana’s informed consent law—a law that fully complied with the USSC’s requirements for such laws (as set out in the 1992 Planned Parenthood v. Casey decision)—from going into effect.  The Seventh Circuit—the same court to which he is nominated—later reversed him, stating “[n]o court anywhere in the country (other than one district judge in Indiana [i.e., Hamilton]) has held any similar law invalid in the years since Casey.”

In response to Hamilton’s nomination, the New York Times opined that Hamilton’s nomination was meant to send a signal as to the types of judges President Obama would appoint.  Thus, it is clear President Obama will appoint hard-core abortion proponents—judges who will read the spirit and intent of FOCA into the U.S. Constitution and invalidate medically-supported and common-sense regulations or restrictions on the abortion license—to the federal bench and to the US Supreme Court.

President Obama’s first nomination to the Supreme Court validates this fear.  Judge Sonia Sotomayor’s record on abortion strongly suggests that she will be even more extreme on the issue than Justice David Souter, who she has been nominated to replace.  For example, while Judge Sotomayor was on the board of the Puerto Rican Legal Defense and Education Fund (PRLDEF), it filed amicus briefs with the Supreme Court

• That, in essence, called upon the Supreme Court to read the “Freedom of Choice Act” (FOCA) into the Constitution, protecting abortion as a fundamental right and applying the most stringent level of judicial review – known as “strict scrutiny” — to strike down common-sense abortion regulations and restrictions supported by the vast majority of Americans such as informed consent, parental involvement, and bans on partial-birth abortions.
• That urged the Supreme Court to strike down a Missouri law requiring viability testing before certain abortions — calling such testing “useless and expensive.”
• That declared that it “oppose[d] any efforts to . . . in any way restrict the rights recognized in Roe v. Wade;” compared abortion to the specifically-enumerated, First Amendment right to free speech, and argued that any “burden” on the right to abortion was unconstitutional.
• That characterized informed consent requirements as “intrusive,” “distorted,” and “designed to frighten women from obtaining abortions.”
• That argued that all “medically necessary” abortions (essentially, code words for abortion-on-demand) must be publicly funded and that failure to do so was “discriminat[ory]” and a violation of constitutional equal protection guarantees.

President Obama has also appointed advisors who can be expected to ensure radical choices for the judiciary.  For example, on March 12, 2009,  President Obama nominated Ronald Weich as Assistant Attorney General for the Office of Legislative Affairs.  This position is responsible for advising the President on the selection and successful nomination of federal judges.  During the Bush Administration, testifying before Congress about the “Unborn Victims of Violence Act,” which passed Congress with large bipartisan majorities, Weich said that the Act was “just one more step in the anti-abortion movement’s methodical strategy to humanize fetuses, marginalize women, demonize abortion providers, and make the image of abortion less palatable to the American people.”
Federal Spending and Other Budgetary Measures

A deep economic recession, burgeoning federal deficits, and budget cutbacks in critical areas such as national defense are not dissuading abortion advocates from demanding increased taxpayer funding for their radical abortion-on-demand agenda.  Unfortunately, Congress and the Administration are more than happy to comply.

On March 11, 2009, President Obama signed the fiscal 2009 Omnibus spending measure.  This $410 billion measure needed to keep the federal government functioning through September 2009 also included significant distributions of U.S. taxpayer dollars to international family planning programs—programs that often promote abortion and sterilization as effective and acceptable means of family planning.
First, the measure allocated $50 million to the United Nations Population Fund (UNFPA) for its work in more than 150 countries around the world.  The UNFPA’s stated mission is to promote the right of every woman, man, and child to enjoy a life of health and equal opportunity.  UNFPA claims to support countries in “using population data for policies and programs to reduce poverty and to ensure that every pregnancy is wanted, every birth is safe, every young person is free of HIV/AIDS, and every girl and woman is treated with dignity and respect.”  However, UNFPA is on record arguing that abortion is an appropriate solution to child poverty and has also been complicit in brutal population control programs in China, North Korea, and elsewhere that include forced abortions, forced sterilizations, and other human rights abuses.
Further, the spending measure provided $545 million for a variety of bilateral and multilateral family planning and “reproductive health” [i.e., abortion-promoting] programs worldwide.  This allocation is $82 million over 2008 funding levels and a 66 percent increase over the budget request made by the outgoing Bush Administration.

Not surprisingly, officials from the United Nations and other international family planning groups welcomed the new Administration’s support.  For example, Tod Preston, Vice President for U.S. Government Affairs at Population Action International, an American-based group supporting population control efforts, enthused that the new Administration’s actions “represent[ed] the last vestiges of a failed effort by the previous administration to decimate U.S. family planning and reproductive health programs.”

During the Congressional debate over this measure, the Senate rejected (by a vote of 38 to 55) Senator Roger Wicker’s (R-MS) attempt to protect US taxpayers from funding coercive abortions through UNFPA.  The Wicker Amendment would have restored the Kemp-Kasten Amendment, which has been in place since 1985 and which denies federal funding to organizations or programs the President determines support or participate in a program of coercive abortion or involuntary sterilization.

Action on Budgetary Riders

The repeal of established provisions and policies prohibiting or limiting federal funding of abortion is a top priority of pro-abortion groups like Planned Parenthood.  Often called “pro-life riders,” abortion advocates want Congress to eliminate these provisions and policies and quickly authorize the use of taxpayer dollars to pay for abortion-on-demand.

Appropriations provisions or riders prohibiting or limiting the use of taxpayer funding for abortion and contraception are already under attack and many remain vulnerable.  Importantly, these riders are not permanent law and must be regularly renewed by Congress to remain in effect.

Congress has already rendered the Kemp-Kasten Amendment, prohibiting U.S. taxpayer funding of programs that include coercive abortions, impotent (by the passage of the fiscal 2009 Omnibus spending measure).  Later, in June 2009, Congress began debating the Obama Administration’s proposal to use taxpayer funding to pay for abortions in the District of Columbia, invalidating the long-standing Dornan Amendment that prohibit such practices.  Clearly, negative action on additional riders like the Hyde Amendment, the Hyde-Weldon Amendment, and others is not far behind.

The Hyde Amendment, first enacted in 1976, prohibits Medicaid and any other federal program from funding abortions except in cases of rape or incest, or to save the mother’s life.  Meanwhile, the Hyde-Weldon Amendment, first enacted in 2004, protects the freedom of conscience of healthcare providers by prohibiting programs that receive federal funds from discriminating against healthcare providers who refuse to provide, pay for, provide coverage for, or refer for abortions.  Notably, both of these important riders have survived multiple court challenges and been deemed constitutional.  However, pro-abortion groups are actively lobbying for their repeal and, unfortunately, Congress and the White House are likely to comply.

Federal Legislation

Members of the 111th Congress have already introduced at least 14 measures relating to abortion and family planning services.  Nine of these measures are demonstrably pro-life, while five would provide expanded funding for “comprehensive family planning services” (including abortion) and are likely to result in an increased taxpayer-provided income stream for groups like Planned Parenthood.

Interestingly, the White House, Congressional leaders, and the media are expressing the most positive interest and attention to measures that would increase taxpayer funding of groups like Planned Parenthood.  The most notable of these measures is the “Prevention First Act” (S. 22 and H.R. 463) sponsored by Senate Majority Harry Reid and nearly 150 other members of Congress and championed by Planned Parenthood.  The “Prevention First Act” has several key components:

• Making Title X of the “Health and Human Services Act” a permanent program and providing it with at least $700 million in taxpayer funding each year.  Since its inception in 1970, Title X has been a major funding source for Planned Parenthood.  However, like many pro-life appropriations riders, Title X is not currently a permanent program and must be reauthorized every year.  Under the “Prevention First Act,” Planned Parenthood stands to more than double the taxpayer funding it currently receives under Title X.
• Mandating health insurance plans covering prescription drugs also cover contraceptives.  There are no exemptions for religious employers or others with conscientious objections to contraception.
• Creating an educational program to promote “emergency contraception.”  Notably, Planned Parenthood and its affiliates are major distributors of “emergency contraception,” often selling it at a significant mark-up.
• Removing federal funding from hospitals that fail to provide “emergency contraception” to sexual assault victims.  Again, there are no exemptions for Catholic or other religiously-affiliated hospitals.

Efforts to Reform the Healthcare System

President Obama has consistently maintained that a complete overhaul of the nation’s healthcare system is one of his top priorities.  He has already taken steps to bring about his expansive vision of universal healthcare coverage, including comprehensive abortion and family planning services funded by taxpayer dollars.

On March 5, 2009, President Obama hosted the White House Health Care Summit, purporting to bring together 150 healthcare leaders, including key members of his Cabinet, White House staffers, members of Congress, and others to discuss how to reform the nation’s healthcare system.  Among those invited to participate was Cecile Richards, President of Planned Parenthood, along with other abortion supporters.  Notably, the President asked no pro-life healthcare group to participate.

During the Summit, Richards opined that healthcare reform must ensure women have “access to comprehensive family planning and reproductive healthcare”—more code words for unrestricted and unregulated abortion-on-demand.  She also promoted universal healthcare including abortion services funded by taxpayer dollars.  Notably, this was not Richards’ first opportunity to expound on her vision of comprehensive, taxpayer-funded “reproductive healthcare.”  In August 2008, she addressed the Platform Committee of Democratic National Committee, then-chaired by Janet Napolitano, now a member of President Obama’s Cabinet.

Interestingly, as the debate over healthcare reform has begun in earnest, pro-abortion groups like Planned Parenthood and NARAL Pro-Choice America have become alarmed over any suggestion that government healthcare programs might not include expansive and generous coverage for “reproductive healthcare” including unfettered abortion-on-demand and have aggressively urged their supporters to contact Congress demanding such coverage.

Potential Ratification of International Conventions & Treaties
The U.S. Constitution gives the Senate power to ratify international treaties and conventions and make them binding on American law and citizens.  They may ratify treaties and conventions with or without “reservations”: unilateral statements purporting to exclude or modify the legal obligations of the treaty or convention and its effects on the reserving nation or government.
In recent years, a variety of international conventions—many of them originating with the United Nations—have been developed and have as their stated or implied purpose the expansion of abortion rights and the repeal of laws regulating or limiting abortion.  To date, the U.S. has not ratified any of these conventions, but Americans cannot underestimate the negative impact of potential ratification.
In February 2009, Senator Barbara Boxer (D-CA)—a vocal supporter of abortion-on-demand—promised to call on Secretary of State Hillary Clinton and the U.S. State Department to complete their review of the U.N. Convention on the Rights of the Child (UNCRC) and transmit it to the Senate for immediate ratification.
If ratified, this international convention could severely undermine parents and their inherent right and responsibility to care for and raise their children without unneeded governmental oversight and interference.  It would also directly undermine U.S. sovereignty and the enforceability of American laws, subjecting U.S. citizens and American laws to the administrative oversight—and even veto power—of the United Nations and its unelected bureaucrats.
A fundamental presumption of UNCRC is that parental responsibility exists only insofar as parents are willing to further the independent choices of their children.  To advance the convention’s purposes—seeking to make children (even young children) autonomous from their parents and arguably supplanting parents with the State—the convention grants to children a list of inviolable and radical rights including “the right to privacy,” “the right to freedom of thought and association,” and “the right to freedom of expression.”
Specifically, the Convention’s right to privacy provisions could be used to undermine and eliminate laws mandating parental involvement in a minor daughter’s abortion decision.  Article 16 of the convention purports to invest a minor with an absolute right to privacy, which, in light of the U.N.’s historic support for unfettered abortion-on-demand, would necessarily permit a minor to obtain an abortion without the benefit of parental involvement and even without her parents ever knowing about the abortion.  Article 19 of the Convention permits the “identification, reporting, referral, investigation, treatment, and follow-up” of those—including parents—who interfere with a child’s fundamental rights, including the right to privacy.
UNCRC is not the only international convention yet to be ratified by the Senate that embodies the spirit of FOCA and implements key components of its radical abortion-on-demand agenda.  Abortion advocates and their allies have long agitated for the ratification of the U.N. Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW).
CEDAW was signed by President Jimmy Carter in 1980, but it has never been ratified by the Senate.  Notably, while the word “abortion” does not appear in the actual text, Article 12 of CEDAW asserts that ratifying nations “shall take all appropriate measures to eliminate discrimination against women in the field of health care in order to ensure, on a basis of equality of men and women, access to health care services, including those related to family planning.”  Many official bodies—both inside and outside the U.N.—interpret this Article and other related provisions to condemn all limitations or restrictions on abortion as per se discrimination against women.
In practice, U.N committees and bureaucrats have consistently used CEDAW as the basis for criticizing member nations and pressuring them to weaken or repeal laws restricting abortion, to provide public funding of abortion, and to even eliminate laws protecting the conscience rights of healthcare providers who decline to participate in abortions.
Not surprisingly, support for CEDAW is strong and widespread among abortion advocates.  For example, the Center for Reproductive Rights (CRR), a New York-based group dedicated to using “the law to advance reproductive freedom as a fundamental human right that all governments are legally obligated to protect, respect, and fulfill,” has consistently called for the ratification of CEDAW with “no reservations” so that its spirit and intent could be fully implemented in the U.S.  Notably, CRR actively opposes any limits or restrictions on abortion and regularly files federal and state lawsuits seeking to derail laws regulating abortion.
Moreover, CRR and other abortion advocates routinely argue that CEDAW cements abortion as a fundamental human right and mandates unfettered abortion-on-demand in the U.S. and elsewhere.  For example, in their 2001 lawsuit in federal district court seeking to strike down the Mexico City Policy, CRR cited U.N. conventions and customary international law as support for the bold assertion that “abortion is the law of the world.”
Clearly, with abortion supporters currently in control of the Senate, the ratification of UNCRC, CEDAW, and international conventions promoting abortion-on-demand is a distinct and troubling possibility—one that would effectively usher in an era of unregulated and unrestricted abortion in America and invalidate any federal or state limitation on or common-sense regulation of abortion.
Conclusion

Recently, Rep. Jerrold Nadler (D-NY), a chief Congressional proponent of FOCA, promised that FOCA would be introduced in the 111th Congress “sooner rather than later,” but he did not elaborate on specific plans for its introduction and debate.  However, it is clear from the actions of the Obama Administration, Congress, and their pro-abortion allies that a campaign to implement FOCA-by-Stealth is already well underway.  If we are to effectively counter this radical agenda, we must remain vigilant and continue to speak out against any legislation, policy, or action by the Administration or Congress that furthers the spirit of FOCA and its radical vision of an America (and a world) of unrestricted, unregulated, unapologetic, and taxpayer-funded abortion-on-demand.

The Administration, Congress, and abortion advocates are counting on the economy and other pressing issues to divert the attention of the American people so they can surreptitiously and with little resistance advance their radical pro-abortion agenda.  We cannot afford them success.  Future generations are literally counting on us to remain motivated and vigilant against this discretely and stealthily advancing culture of death.