FDA Takes Decisive Action to Further Delay Taking Action


The FDA's current tactic for delaying approval of over-the-counter status of the morning-after pill involves regulators asking themselves tangential questions about the drug and subsequently claiming to have no idea what the answers to those questions might be. The most recent justification came by way of a nonsensical August press release:

The question we have been asked to address is whether Plan B should be available without a prescription…for women age 16 and older, and remain prescription-only for those under the age of 16.

The issues that we were asked to resolve, and the proposal that was put forward by Barr Labs, presented us with many difficult and novel policy and regulatory issues.

That "difficult and novel" problem is one of the agency's own making. The FDA's scientific advisory board has recommended over-the-counter Plan B be accessible to all women, not just those 16 and over. It was FDA policy makers who then insisted that Plan B had not been adequately tested for adolescent females. Barr put forward a proposal to make the drug available to adult women, and FDA regulators almost immediately insisted they had no idea how to make a drug easily available to women but not girls.

Yesterday, Rep. Henry Waxman (D-Calif) claimed to have obtained documents demonstrating that the FDA had actually been considering those same regulatory questions for over a year before announcing that they were in fact "novel" and required an indefinite time period to hash out. (The August FDA statement was followed by a 60 day comment period, followed by silence; apparently FDA policy makers are slow readers.) Waxman has asked for an explanation. The FDA has offered no response as yet, but is currently "reviewing the matter."