Contraception Emergency

Anxious seekers of over-the-counter emergency contraception must continue to find an alternate plan. But it certainly won’t be Plan B, the emergency contraceptive, or “morning-after pill,” that the Food and Drug Administration (FDA) deemed unfit for over-the-counter distribution last May. The Government Accountability Office (GAO), a nonpartisan investigative subsidiary group of Congress, reported recently that top FDA officials decided to reject the application of Plan B months before the government scientific review of the application was complete.

The FDA is supposed to be a nonpartisan agency, and its role is to gauge the safety of drugs based upon scientific research. Its role is not, in any capacity, to judge drugs along party lines. It appears that the decision concerning this drug was partisan, because the decision to keep Plan B off the shelves was made by the highest-ranking members of the FDA before the scientific reviews were complete.

In response to the GAO’s allegations, the FDA said that they did indeed base their decision on scientific proof. Dr. Steven Galson, director of the Center for Drug Evaluation and Research—the internal organization which rejected the Plan B application—said that he issued a “non-approvable” letter concerning the drug because only 29 of 585 participants in a study of the drug had been ages 14 to 16, with no participants under the age of 14. He claimed that younger teenagers might engage in riskier sex if they knew that emergency contraception was available, even though the study found that adolescents could use the drug appropriately. The GAO called this rationale “novel,” as the FDA consistently uses the behavior of older adolescents to predict the behavior of younger adolescents when making decisions concerning teenage use of drugs.

While the FDA claims to be unconvinced by the drug studies, 39 other countries—including the United Kingdom, Canada, and India—have deemed this drug safe for over-the-counter sales. There is also an important distinction to be made: Plan B is not abortion; the FDA itself designated Plan B as contraception. According to Planned Parenthood, “Experts estimate that wider access to emergency contraception could prevent up to 1.7 million unintended pregnancies a year—and 800,000 abortions.” In other words, if Plan C(ontraceptive) fails, and women cannot access Plan B, many will be forced into Plan A(bortion).

Unfortunately, this partisan, “novel” decision does not only affect the integrity of the FDA; it also compromises the safety of women. Plan B can prevent pregnancy if taken within 72 hours of unprotected sex, but is most effective when taken soon after sex. It is often difficult for women to see a doctor and obtain a prescription within this time period, and therefore it is essential that women have easy access to emergency contraception within the period of its effectiveness. Recognizing this, Harvard University Health Services gives students easy access to Plan B prescriptions. It is a commendable way to combat the consequences of a flawed FDA ruling.

If the FDA continues to inject politics into drug decisions, it will undermine the credibility of its evaluations of drug safety. For the short term, the FDA should reconsider Barr Pharmaceutical’s application to make Plan B over-the-counter. For the long term, the FDA must acquiesce to permanent oversight in order to prevent missteps like these from happening in the future.