In a decision loaded with withering criticism of Health and Human Services Secretary Kathleen Sebelius and the FDA, a federal court last week ordered the FDA to permit the form of “emergency contraception” best known by the brand name “Plan B”[i] to be available to anyone without a prescription, regardless of age. Further, the court held that the FDA could not require sellers of the drug to keep it behind the counter—it must be placed on store shelves for easy access.
This development came after a nearly 10-year battle that began when a group of pro-abortion organizations and individuals brought an action against the FDA to challenge the agency’s refusal to grant “Plan B” over-the-counter (OTC) status for women of all ages.
In 2011, the FDA approved the “Plan B” manufacturer’s request to allow OTC access to “Plan B” for all ages. However, Sebelius invoked her authority under the Federal Food, Drug, and Cosmetic Act to order FDA Commissioner Margaret Hamburg to deny OTC status for “Plan B.”
At that time, Secretary Sebelius stated that
[T]he data . . . do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age. … It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.[ii]
President Obama agreed with Sebelius’ rationale, stating that “the reason [Secretary Sebelius] made this decision is that she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able—alongside bubble gum or batteries . . . to buy a medication that potentially, if not used properly, could have an adverse effect.”[iii]
The federal court, however, did not buy the arguments made by Sebelius and President Obama: “This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed.” The court further stated that the OTC prohibition was a politically driven excuse “to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”
The court acknowledged that the case was “particularly controversial” because it involved “emergency contraception” for minors and because of what he characterized as “scientifically unsupported speculation” that “Plan B” can end a life (more on this below). Nevertheless, the court held that “the issue in this case involves the interpretation of a general statutory and regulatory scheme relating to the approval of drugs for over-the-counter sale.” For this reason, the court held that the FDA departed from its general policies in its consideration of OTC status for “Plan B,” and, therefore, abused its discretion.
Plan B’s Potentially Life-Ending Effect
The court cited authorities who do not agree that “Plan B” has a life-ending mechanisms of action; however, Kathleen Sebelius, the Secretary of Health and Human Services (HHS), has admitted that the FDA’s definition of “contraception” is not limited to a drug’s ability to prevent fertilization, but extends to blocking the implantation of an already developing human embryo: “The Food and Drug Administration has a category [of drugs] that prevent fertilization and implantation. That’s really the scientific definition.”[iv]
In his most recent study on “emergency contraception,” Dr. James Trussell, whose research concerning “contraception” has been cited by the FDA, states: “To make an informed choice, women must know that [emergency contraception pills] . . . may at times inhibit implantation. . . .”[v] In other words, Dr. Trussell, although an advocate of “emergency contraception,”[vi] believes that the scientific difference between a drug that prevents fertilization and one that may also prevent implantation is significant enough that it must be disclosed to a potential user.
Strikingly, Dr. Warren Wallace, a physician at Northwestern University Medical School who has “prescribed emergency contraceptives,” and who was called to testify in support of a law restricting rights of conscience pertaining to the prescription of “emergency contraception,” testified under oath that “there is a new unique human life before” implantation of an embryo.[vii]
Although called “contraception,” the FDA’s labeling acknowledges that “Plan B” can prevent implantation of a human embryo.[viii] Further, the FDA states on its website:
Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation).[ix]
The same explanation is provided by Duramed Pharmaceuticals, the manufacturer of “Plan B One-Step.” Duramed states that “Plan B One-Step” “works primarily by”: 1) preventing ovulation; 2) possibly preventing fertilization by altering tubal transport of sperm and/or egg; 3) altering the endometrium, which may inhibit implantation.[x]
Plan B and Minors
The court acknowledged few minors were included in “actual use” studies on the safety of Plan B; rather, the F.D.A. initially voted to approve the use of “Plan B” by minors based on study data from older age groups. Further, “label comprehension” studies enrolled few young adolescents, raising concerns that girls as young as 10 or 11 could incorrectly use the drug. Moreover, given the newness of the drug, it is impossible to know the long term effect it may have on minors’ developing bodies.
The Obama Administration can and should appeal this decision. Yes, there are other drugs available over-the-counter that can harm minors. However, “emergency contraception” cannot be compared to Tylenol or cough medicine. Minors who rely on “Plan B” for contraception are not protected from sexually transmitted diseases. Further, men who abuse women and girls have also been known to give these drugs to their victims in an effort to cover their crimes. Permitting OTC access to the drug for minors removes even the limited protection or accountability that having to interact with another human being to obtain the drug might afford.
If President Obama fails to appeal this decision, his lack of action will appear to confirm the accusation that Secretary Sebelius’ earlier decision to prohibit OTC status for Plan B, as the federal district court asserted, was only politically motivated (this was the first time a cabinet member ever countermanded a decision by the F.D.A., and it occurred immediately prior to an election year). With the election behind him, President Obama has an opportunity here to show that he truly does want to protect young girls from a very serious drug with potentially life-changing consequences.
[i] The original drug “Plan B” is no longer on the market according to the court opinion. Instead, Plan B One-Step, which requires one pill rather than two, is available. For sake of brevity we will simply refer to either or both of these drugs as “Plan B.” Plan B’s effect is not limited to preventing ovulation or conception—it also has a post-fertilization (i.e., life-ending) mechanism of action. In other words, Plan B can end a developing, distinct human being’s life by preventing implantation.
[ii] A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius (Dec. 7, 2011), available at http://www.hhs.gov/news/press/2011pres/12/20111207a.html (last visited Apr. 8, 2013).
[iii] Obama Backs Limit on Sale to Teenagers of Morning-After Pill, NYT (Dec. 8, 2011), available at http://www.nytimes.com/2011/12/09/us/politics/obama-expresses-support-for-plan-b-decision.html (last visited Apr. 8, 2013).
[iv] Kelly Wallace, Health and Human Services Secretary Kathleen Sebelius Tells iVillage “Historic” New Guidelines Cover Contraception, Not Abortion, iVillage, Aug. 2, 2011, available at http://www.ivillage.com/kathleen-sebelius-guidelines-cover-contraception-not-abortion/4-a-369771 (last visited June 12, 2012).
[v] J. Trussell et al., Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy, Office of Population Research at Princeton University (June 2010).
[vii] Transcript of Bench Trial at 91-92, 111, Morr-Fitz, Inc. v. Quinn, 2012 IL App (4th) 110398 (Ill. App. Ct. Sept. 20, 2012).
[viii] Plan B Approved Labeling, available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021045s011_Plan_B_PRNTLBL.pdf (last visited Sept. 30, 2012).
[ix] FDA, FDA’s Decision Regarding Plan B: Questions and Answers (updated Apr. 30, 2009), available at http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm (last visited Sept. 30, 2012) (emphasis added).
[x] Duramed Pharmaceuticals, How Plan B One-Step Works (2010), available at http://www.planbonestep.com/plan-b-prescribers/how-plan-b-works.aspx (last visited Sept. 30, 2012) (emphasis added).