Just because you can, doesn’t mean you should. Kathleen Sebelius, the Secretary of Health and Human Services, seemed to understand this age-old wisdom in 2011 when she ordered the FDA to deny over-the-counter availability for “emergency contraception” (EC), best known by the brand name “Plan B.”
President Obama agreed with her, 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.”
Tragically, the administration’s conviction on this critical issue was short-lived. Soon after a federal court ordered the FDA to permit the availability of “Plan B” without a prescription, regardless of age, on store shelves for easy access, the FDA narrowed restrictions on access to “Plan B”, permitting it to be available over-the-counter to girls as young as 15.
Then, on Monday, President Obama’s administration announced that it was abandoning efforts to appeal the court’s decision altogether, and the FDA provided details on how it would achieve compliance with the court order.
In its decision to require over-the-counter availability for “Plan B,” the court emphasized that the FDA, under pressure from Secretary Sebelius, had departed from its general policies in its consideration of over-the-counter status for “Plan B.” The court focused on the safety and effectiveness of “Plan B,” but rejected other strong public health rationales for why over-the-counter status should not be granted to the drug.
The Obama Administration’s about face is not surprising; however, by kowtowing to the court’s reasoning, the Administration is setting a dangerous precedent that safety and efficacy, even if established, is all that matters—other public health rationales have no place when considering whether parents and doctors should be part of a minor’s decision whether to take a potentially life-ending drug.
This precedent opens the door for the FDA or a court to require over-the-counter availability of other, even more dangerous drugs, without age restrictions. The FDA has classified the drug Ulipristal Acetate (ella) as “emergency contraception,” even though ella is actually an abortion-inducing drug—it can kill an embryo after implantation. What is to stop the FDA from later approving ella or another newly-developed life-ending drug, wrongly categorized as “emergency contraception,” for over-the-counter availability?
Public health arguments against over-the-counter status for “Plan B” should be considered. Parents and healthcare providers can see the “big picture” when they are included in a minor’s decision to seek “emergency contraception.” Tragically, a minor’s visit to a healthcare provider to receive an “emergency contraception” prescription may present the only opportunity for an adult to identify and intervene in cases of abuse.
The 2004 report “Statutory Rape: A Guide to State Laws and Reporting Requirements,” prepared for the Office of the Assistant Secretary for Planning and Evaluation at HHS, noted that half of children born to minors are fathered by adult men, and sexual partners of these adolescents are often three to six years older.
Planned Parenthood acknowledges in its fact sheet on “reducing teenage pregnancy” that “teenagers who have been raped or abused experience higher rates of pregnancy — 4.5 out of 10 pregnant adolescents likely have a history of abuse.” The group also notes that “teenage girls with a history of abuse are more than twice as likely to become pregnant as peers who do not experience abuse.”
Among women younger than 18, the pregnancy rate among those with a partner who is six or more years older is 3.7 times as high as the rate among those whose partner is no more than two years older. These issues just underscore the importance of a parent or health-care provider’s involvement in obtaining “Plan B.”
Without a visit to a healthcare professional, a minor will not receive counseling, including counseling on abstinence, sexually transmitted disease screening and treatment, and general well exams and screenings. It is also much less likely that a minor will understand on her own that “Plan B” does not just prevent ovulation or fertilization—it can prevent implantation after a baby has already been conceived.
“Plan B” does not protect against STDs, the occurrences of which have reached epidemic proportion. The Center for Disease Control “estimates that nearly 20 million new sexually transmitted infections occur every year in this country, half among young people ages 15–24. Each of these infections is a potential threat to an individual’s immediate and long-term health and well-being. In addition to increasing a person’s risk for HIV infection, STDs can lead to severe reproductive health complications, such as infertility.”
Even if the FDA has the authority to permit minors to take “Plan B” without the guidance of parents or healthcare professionals, President Obama and his Administration have the responsibility to see to it that these public health considerations are taken seriously—and ultimately prevent the over-the-counter sell of “Plan B” to minors. By failing to appeal the court’s decision, President Obama and his Administration have abdicated their responsibility to young women.
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 The “safety” of Plan B usage for minors is not established. The court acknowledged that few minors were included in “actual use” studies on the safety of Plan B. Instead, the FDA vote to approve the use of Plan B by minors was based on study data from older age groups. Significantly, given the relative newness of the drug, it is impossible to know the long-term effects Plan B may have on minors’ developing bodies.
2 For more on “Plan B”’s life-ending mechanism of action, see Children at Risk as Dangerous “Plan B” Drug Comes to a Store Shelf Near You; How the FDA’s Plan B Decision Puts Minors at Risk.