The Food and Drug Administration has once again delayed making a decision concerning emergency contraception. This delay comes more than two and a half years after the manufacturer of the drug – typically referred to as Plan B or the morning-after pill – asked to make it accessible over the counter. This deferral reneges on a promise the FDA’s recently appointed chairman Lester Crawford, made this summer. Indefinitely postponing this decision shows that the FDA – influenced by political concerns – is simply trying to avoid the hot-button issue.
It is difficult to see this delay as anything but politically motivated. Plan B has been available on the prescription market for six years, and doctors continue to write prescriptions for the drug to women all over the country. There is too much evidence in the drug’s favor to believe that there are real concerns over its safety, as the drug’s safety has been proven by several studies over the years. In fact, in December of 2003, an FDA advisory committee voted with an overwhelming majority that Plan B should be approved for over-the-counter use.
Despite everything working in favor of the drug, this vote was ignored due to a perceived need for more research on whether the drug was safe in women under 16. More than two years later, the FDA is still making similar excuses concerning its safety, claiming that recent studies are contain too few subjects and do not evaluate certain long-term effects.
The decision to overlook the advisory committee’s recommendations as well as its refusal to step up to the plate in making a concrete decision shows that the FDA is unwilling to work as the apolitical organization it is supposed to be. Simply put, it is stalling because of concerns about the political fallout of its decision. Sen. Patty Murray (D-Wash.), a member of the Senate Health, Education and Labor Committee, said this summer: “The case of the Plan B highlights a leadership problem at FDA – a leadership that can be biased or open to undue influence.”
Indeed, under Crawford’s insufficient leadership, the FDA is more worried these days about political ramifications than the public’s health – its jurisdiction. The FDA needs to realize that it is not a legislative body. Political concerns should have no influence over its decisions.
In the absence of action by the FDA, alternate channels to provide a legitimate prescription for emergency contraception have sprung up. Websites such as GetThePill.com allow women to make prescription requests that can later be picked up at neighborhood pharmacies. But women should not have to resort to such roundabout measures to obtain emergency contraception. With the current information on Plan B, there is no need to prevent it from becoming available over the counter. The FDA needs to remember that its role is to determine whether drugs are safe for the market and make its decisions accordingly. If the FDA delays its Plan B decision any longer, its authority as a politically neutral, objectively run and trustworthy organization will be undermined.