THIS WEEK the Government Accountability Office released a report describing in great detail the Food and Drug Administration's 2004 decision not to approve over-the-counter sales of the emergency contraception drug Plan B. The report concludes that the decision was "unusual." The FDA acknowledged this at the time, although officials deny that the decision was political or made under the influence of the conservative religious groups that have lobbied against the drug. The officials say they overruled a scientific committee's recommendation of over-the-counter sales on the grounds that not enough evidence was available about the drug's effect on young teens. As we wrote at the time, this was not an unreasonable objection. Nor was there anything wrong with treating a controversial drug unusually -- once.
Since then, however, the debate has moved on. The company that makes Plan B, Barr Laboratories Inc., produced a proposal -- in accordance with the FDA's suggestion -- to sell the drug in two ways: over the counter for those older than 16, with a prescription for younger girls. The FDA's Center for Drug Evaluation and Research, including the officials who opposed the original application, signed off on that plan. But the FDA then made an even more unusual second decision. Now the objections are coming from a different corner of the administration, from legal staffers who say special rules are needed before the agency can agree to sell the drug in different ways.
As a result, all decisions about the drug have been suspended -- apparently indefinitely. Susan F. Wood, the FDA assistant commissioner for women's health, has resigned over the issue, and FDA commissioner Lester M. Crawford has resigned under mysterious circumstances -- possibly personal, or possibly connected with this issue, too. The focus of Congress's attention should be on the more recent events, on unblocking the impasse over this decision, on uncovering the reasons for Mr. Crawford's resignation, and on getting the administration to explain why it has allowed an enormously important and influential regulatory agency to remain leaderless for so much of its time in office.