Back to Plan B
IF TIMING IS EVERYTHING, then the U.S. Food and Drug Administration’s announcement Monday was awfully convenient. The agency expressed newfound interest in meeting with the maker of the morning-after contraceptive drug, known as Plan B, just one day before Senate confirmation hearings are set to begin for the Bush administration’s nominee to be FDA commissioner.
The FDA said that it would work with Barr Pharmaceuticals Inc. “to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option.” If it follows through on that promise, then American women -- and the U.S. system of checks and balances -- will be the real winners. After years of delay, the FDA may finally have been embarrassed into approving the pill for women 18 and older.
When Dr. Susan F. Wood resigned a year ago as director of the agency’s office of women’s health, she protested political interference in the FDA’s work. Lawsuits revealed information that political appointees ignored both science and protocol to advance a conservative religious agenda irrelevant to the FDA’s job of determining whether drugs are safe and effective. The Government Accountability Office weighed in with a report confirming that the May 2004 refusal to allow over-the-counter sales of Plan B involved political shenanigans that deviated from agency practice.
Then two Democratic senators threatened to block Dr. Andrew C. von Eschenbach’s confirmation until the FDA took action. Von Eschenbach, a respected Texas surgeon, has done well in the post since being appointed acting commissioner last fall.
But the two senators, Patty Murray of Washington and Hillary Rodham Clinton of New York, are insisting on official approval of Plan B before they allow Von Eschenbach’s nomination to go forward. Their position is understandable; the previous FDA commissioner, Lester M. Crawford, had vowed to approve the drug before his confirmation, then backed away after he got into office.
There is every reason to make this pill readily available without a prescription. It is most effective when used within 24 hours after intercourse. Despite what its detractors say, it is not an abortion pill but a contraceptive, one that works mainly by preventing the release or fertilization of an egg. Studies show that women are no more likely to engage in unprotected sex with it.
If the FDA is truly ready to give Plan B its approval, then Von Eschenbach surely will not mind a short delay in his confirmation while the agency and the drug maker work out the details. And maybe Monday’s announcement is a sign that the FDA is less interested in acting as the judge of women’s morals than as the protector of their health.
