FDA APPROVES PLAN B OTC, GETS SUED AGAIN

The FDA's approval of Barr Laboratories' controversial Plan B contraceptive has removed Senate objections to Andrew von Eschenbach's nomination to be FDA commissioner but has landed the agency in more legal trouble.

The FDA Aug. 24 approved OTC sales of Plan B (levonorgestrel) for women 18 and older, ending what some saw as a politically motivated three-year delay. Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) held a teleconference within hours to announce they will lift their threatened hold on von Eschenbach. However, any hopes the decision will make the FDA's legal problems go away faded as the agency is still the subject of a lawsuit filed by a reproductive rights group that objects to the agency's decision to restrict the age of women who can buy the product OTC. To make matters worse, the agency is about to become the subject of another suit filed by a conservative group that staunchly opposes easing access to the drug.

Clinton told reporters that, while she is concerned about the age restriction, the approval "demonstrates the agency is returning to its original mission of science over politics." She also said von Eschenbach would get her vote as long as the answers he provides to questions raised during his testimony earlier this year before the Senate Health Education Labor and Pensions Committee do not "raise any red flags." The committee will review his answers when Congress reconvenes in September.

Clinton and Murray had said they would hold up von Eschenbach's nomination until the FDA reached a decision on Plan B, a pledge they repeated during his confirmation hearing earlier this month.

Even in August, considered the sleepiest month of the year for Capitol Hill, many other Democratic offices churned out responses supporting the approval but criticizing the agency for its delay and for restricting minors' access to the drug. Consumer advocacy group Public Citizen chimed in as well, calling the delay a "black mark" on the agency and accusing it of caving to "political pressure from social conservatives and the religious right that trumped scientific judgment." President Bush recently said he supports OTC sales of the drug as long as minors cannot obtain it without a prescription.

The agency approved OTC sales of Plan B after Barr's subsidiary, Duramed Pharmaceuticals, submitted an amended drug application Aug. 17, roughly a week after the company and the FDA met to discuss conditions under which the agency would approve OTC use. Those conditions included changing the minimum age for OTC use from 16 to 18 and ensuring that the drug will be kept behind the counter at pharmacies and dispensed only with production of valid photo identification verifying the buyer's age. (http://www.fdanews.com/did/5_167/)