Politicizing the FDA

Tuesday, August 30, 2005

OVER A YEAR ago, when the Food and Drug Administration first rejected Barr Laboratories Inc.'s proposal to sell the emergency contraceptive Plan B over the counter, we agreed that the agency had reason to be cautious. Although the drug -- which contains the same ingredients as contraception pills -- had been proved safe and effective, and although studies showed that its availability did not lead to an increase in sexual activity, there was little hard information measuring the drug's impact on young women. Because some drugs do cause different side effects in adolescents and adults, we argued that the agency was within its rights to ask Barr for a new proposal.

Acting on the FDA's suggestions, Barr then submitted a new application, offering to sell its drug over the counter to adults but to require prescriptions for girls younger than 17. Although not all such FDA suggestions result in approvals, there seemed no reason to doubt that this one would. As recently as last March, the FDA commissioner, Lester M. Crawford, implied as much at his confirmation hearing: "The science part is generally done," he said when asked about the approval process for Plan B. "We're just now down to what the label will look like." He also promised two senators, Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.), that a decision would be made. According to some at the agency, drafts of the approval letter were under discussion.

Then, late last Friday afternoon, Mr. Crawford announced that the agency would delay approval once again. Citing "novel regulatory issues" and "profound" policy questions, he said that the new application required further study and public comment.

With this statement, Mr. Crawford not only broke his word to two senators, but he also put the agency at risk of losing its credibility. In recent months critics have accused the FDA -- which is required by law to make decisions exclusively on scientific and legal grounds -- of falling victim to outside political agendas. They have claimed that the Plan B decisions have reflected not sound science and legitimate caution but rather the influence of "moral" and antiabortion lobbies claiming that Plan B, which mainly acts by preventing fertilization, might occasionally act by dislodging an hours-old fertilized egg and therefore "aborting" it. By abruptly rejecting an application that had been tailored to meet the FDA's requirements, Mr. Crawford appears to confirm the critics' worst fears.

We don't deny that there are legal and practical difficulties involved in selling the same drug in the same package to different age groups. But the agency has not only had past experience with restricted over-the-counter sales of nicotine and tobacco, it has also had plenty of time to communicate its concerns to Barr and to negotiate a workable system. Whatever the legal arguments taking place, this unexpected delay at this stage of the approval process makes the FDA -- long admired around the world for its neutrality and professionalism -- look like an easily manipulated political tool.

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