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.”
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.” 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.
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.
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.
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.
 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).
 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.
 K. Edgardh, Adolescent Sexual Health in Sweden, Sexually Transmitted Infections, 2002, 78: 352-356.
 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).