U.S. Food and Drug Administration officials are slated to meet next week with representatives of Barr Pharmaceuticals Inc. to discuss the long-stalled plan to sell Barr’s emergency contraceptive, Plan B, without prescription. In a July 31 letter to Barr, the FDA suddenly announced that it would be taking a new look at a proposal for over-the-counter sales of Plan B; if the pills – nothing more than an extra dose of the same hormones prescribed in common birth-control pills – would be kept behind pharmacy counters, inaccessible to females under 18 (teens would still need a prescription), then the FDA might finally be OK with the 3-year-old OTC proposal, the FDA letter read.
It might be nice to think that the FDA was simply, finally, coming to its scientific senses regarding emergency contraceptives – moving forward with a plan that the FDA’s science advisers have for years agreed is sound – but unfortunately, the FDA’s latest overture looks more like a case of political expediency than of selfless logical thinking. The letter to Barr came just one day before Dr. Andrew von Eschenbach, nominee for FDA chief, was slated to go before the Senate’s Health, Education, Labor, and Pensions Committee, which must approve his nomination before consideration by the full Senate. The shuck-and-jive caught the attention of Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y., who have vowed to block von Eschenbach’s confirmation until the FDA makes a final decision on whether to allow nonprescription sales of the so-called morning-after pill.
The political promise to make a move on Plan B has come up before, also in the context of confirmation hearings: In 2005 Murray and Clinton dropped their objections to former FDA chief nominee Lester Crawford after Bush administration officials promised that the agency would act swiftly on the Plan B proposal. Once the senators cleared the way for Crawford, the FDA again indefinitely postponed its Plan B decision – indeed, as von Eschenbach was ready to face the senators last week, the agency had yet to act on the 2005 promise. That is, at least, until FDA officials came to the fore on Aug. 1, to promise anew that the agency machine is working, the wheels are turning, and that Plan B sales are poised to become reality. Still, at press time, von Eschenbach’s confirmation had stalled out in committee pending any concrete Plan B action by the FDA.
This article appears in August 11 • 2006.