Nearly two years ago, an FDA advisory panel voted 23 to 4 to approve over-the-counter access to Plan B emergency contraception. One FDA panel member called it the “safest drug that we have seen brought before us.” The scientific evidence was overwhelming and access to Plan B would curtail abortion and unwanted pregnancies. This was a no-brainer — right up until the administration blocked the medication anyway, under pressure from its far-right base.
Yesterday, for the first time, there were signs of progress.
The Food and Drug Administration said yesterday that it was moving toward endorsing sale of the morning-after pill without a prescription for women 18 and older, signaling what may be the end of one of the most stubborn health policy debates of the Bush administration.
The agency’s acting commissioner, Dr. Andrew von Eschenbach, asked the drug’s manufacturer, Barr Pharmaceuticals, for a meeting to complete plans that would allow the over-the-counter sale of the emergency contraceptive, called Plan B. In a statement, the F.D.A. said it hoped “the process can be wrapped up in a matter of weeks.”
While the agency’s letter to Barr was not a final approval, both the F.D.A. and the company expressed optimism about the drug’s future.
An agency spokeswoman, Susan Bro, said the move was intended to bring “this particular issue to a conclusion,” and a federal health official said the agency was committed to making the drug available over the counter. “We see this as a positive development,” said Carol A. Cox, a spokeswoman for Barr.
The WaPo noted that von Eschenbach’s sudden interest in resolving this ongoing dispute “came one day before von Eschenbach’s Senate confirmation hearing, scheduled for this morning.” How incredibly convenient. Dem Sens. Hillary Clinton and Patty Murray have blocked von Eschenbach’s nomination because of his foot-dragging on Plan B, and whaddaya know, the day before his hearing, suddenly the FDA is ready to strike a deal. As Clinton told reporters, the timing “is not a coincidence.”
Regardless of the FDA’s motivations, however, this is good news. Oddly enough, the GOP’s far-right base doesn’t seem to agree.
As the LAT noted that religious-right group have “no intention of relaxing their opposition to wider release of Plan B.”
Fortunately, no one outside the GOP base seems to agree with these activists. By approving Plan B, after years of scandal, broken promises, and often-ridiculous lies, the FDA is finally poised to get it right.
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. […]
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.
At this point, the FDA and Barr Pharmaceuticals should work quickly. As the LAT reminds us, the last FDA commissioner, Lester Crawford, vowed to approve the drug before his confirmation, but broke his word after taking office. With this in mind, Senate Dems should definitely block von Eschenbach’s nomination until the Plan B question is resolved.