The American College of Obstetricians and Gynecologists (ACOG) recently issued a Committee Report recommending that oral contraceptives, more commonly referred to as birth control pills, be made available to consumers over-the-counter (OTC). In a country where half of all pregnancies are unintended, the opinion states that any potential adverse effects of over-the-counter dispersal are outweighed by the numerous benefits. The report emphasized that the risk of side effects from the pills is minimal; in fact, they are not signficantly greater than those posed by aspirin and acetaminophen, which can cause gastrointestinal bleeding and liver damage, respectively.
Birth control pills contain hormones that prevent ovulation, and therefore, conception. In most instances, “active” pills containing hormones are taken for 21 days, followed by placebos for 7 days. In other instances, pills may be taken for a longer period of time, with placebos taken less frequently. In order for oral contraception to be effective, the pill cycle must be uninterrupted. The ACOG cited various studies for the proposition that limited access to oral contraception, including the need to make a medical appointment prior to procuring contraception, prevents many women from using that form of birth control. However, American women indicated a willingness to use oral contraceptives if they would be made available at pharmacies without prescriptions. In addition, a study found that women were more likely to adhere to a regimen of birth control pills when they received multiple one-month pill packs at a time.
The ACOG’s recommendation, however, is far from becoming reality. The Food and Drug Administration (FDA) would have to approve any type of oral contraception before it could be provided over-the-counter. The Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. secs 301-397) provides that the FDA must approve a New Drug Application (NDA) for any new drug being introduced into the market. However, the FDC Act also provides exemptions for drugs that are already “generally recognized as safe and effective” (GRASE). The FDA has compiled monographs for these drugs that list permissible ingredients, dosing, and instructions to treat particular illnesses. Companies that create drugs that adhere to these OTC monographs may market the drugs without FDA approval; those that produce drugs that deviate in any way from the monographs must submit NDAs. The process for approving NDAs and OTC monographs differs. One important difference is that NDA approval requires studies demonstrating that consumers can understand drug labels and use the drugs properly.
Because no monograph exists for typical oral contraceptives, any company interested in marketing such a drug over-the-counter would have to demonstrate that the drug is safe and that consumers understand the labeling. According to the ACOG and other medical professionals, that is the case. The ACOG has indicated that the risk of venous thromboembolism (blood clot within the veins that can potentially lodge in the lungs) in women using oral contraceptives is low, and is actually significantly lower than the risk in pregnant and postpartum women. Furthermore, the ACOG cited studies demonstrating that women can successfully screen for contraindications on their own, without the help of a health care provider.
Some contraceptive proponents who criticize the recommendation worry that the proposed measures will make the pills more expensive for consumers. The Patient Protection and Affordable Care Act (PPACA) (P.L. 111-148) generally requires health insurers to cover the cost of contraception to women. However, insurers are not required to cover the cost of over-the-counter medications. The price of birth control pills generally ranges from $15-$50 a month, or $180-$600 per year, with some brands costing even more. Removing coverage could thus be a severe financial disincentive.
However, the biggest hurdle to FDA approval could be political. PPACA’s birth control mandate is the subject of ire by religious entities who are seeking to have the provision nullified, at least with respect to insurance provided through their organizations. The Obama Administration has been trying to encourage support for PPACA and may not be eager to push another policy unpopular with religious groups. For example, in 2006, the FDA approved Plan B as an over-the-counter form of emergency contraception for women 18 and older. Despite scientific recommendations to the contrary, it did not approve the drug for women and girls under 18. (A federal court later required it to grant approval for use in women 17 and older.) In 2011, however, after years of studies, the FDA determined that the drug was safe and effective for use in girls of child-bearing age below 17–only to be overruled by HHS Secretary Kathleen Sebelius, who stated that research was insufficient to show that the pill was safe and effective for the 10 percent of 11-year-old girls who can bear children. Susan Wood, former FDA Assistant Commissioner, was outraged. “Acetaminophen can be fatal, but it’s available to everyone. So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?”
While newsworthy, the ACOG’s recommendation is not likely to prompt quick action by the FDA. To make contraceptive matters even more interesting, the American Academy of Pediatrics recently issued a policy statement indicating that physicians should prescribe emergency contraception to adolescents in advance of need because they are more likely to use such pills after unprotected sex if the pills are readily available to them. Expect a lot of feedback.