Just when it seemed that controversy over the Plan B contraceptive was a thing of the past, the drug returned to the headlines. In an unprecedented action, Health and Human Services Secretary Kathleen Sebelius overruled FDA’s decision to allow Teva’s Plan B One-Step to be sold over the counter to girls under the age of 17. In a public statement, Sebelius said that about 10% of girls can bear children by 11.1 years of age. Teva’s “label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” she said. But FDA sees the matter differently.
After reviewing the data, obstetricians, gynecologists, and pediatricians at the Center for Drug Evaluation and Research (CDER) determined that Plan B One-Step “was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases,” according to a statement by FDA Commissioner Margaret Hamburg. CDER also concluded “that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider,” according to the statement. And FDA is not alone—the American Academy of Pediatrics also supports over-the-counter access to emergency contraception.
Sebelius’s concern about the ostensible lack of studies including 11-year-olds seems unusual when one considers that many over-the-counter drugs have not been studied in preadolescents—and some are far more dangerous than Plan B One-Step. “Acetaminophen can be fatal, but it’s available to everyone,” Susan Wood, a former FDA assistant commissioner, told The New York Times. “So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?”
FDA places great emphasis on scientific data, as any manufacturer contemplating a process change well knows. In this instance, FDA’s informed decision seems to have been overruled for reasons other than scientific ones.
Also see Christopher Allen and Angie Drakulich’s sidebar “Behind the Counter.”