HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Monday, August 29, 2005

Plan B Delayed

Last Friday, Lester Crawford, Commissioner of the Food and Drug Administration, delayed indefinitely a decision to make Plan B available over-the-counter.  The Washington Post describes his reasons and the responses: 

FDA Commissioner Lester M. Crawford acknowledged that the agency's drug review staff had concluded the drug could be safely used as an over-the-counter drug by women older than 17. But in an unexpected twist, Crawford also said the application raised complicated and unresolved issues about whether current regulations allow a drug to be legally sold by prescription only for teenagers but over the counter for all others.

"What we're saying today is that there are unique regulatory issues here that need to be addressed before we can take a final action on the application," Crawford said. He said he could not estimate how long that might take.

Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) said they were incensed because they had allowed Crawford's nomination as commissioner to move forward this summer only after getting a promise that a decision on the Plan B issue would be made by Thursday.

"I am stunned and outraged and furious," Murray said. "This is not only a broken promise to us, but another frightening example of politics trumping science at the FDA."

The New York Times further reported on the story and the influence that politics appears to be playing in this decision.  It states,

"At some point, the statute requires that the agency make a decision," said Dr. Eve E. Slater, an assistant secretary of health from 2001 to 2003. "You can't just delay forever."

The Plan B decision has become "overly politicized, and it shouldn't be," Dr. Slater added. Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January. Nothing happened. Indeed, Barr executives said they had no discussions with the agency after January. Usually when the agency is actively considering an application, there is a constant back-and-forth with the company.

Today, Senator Clinton called for congressional hearings into the matter of the delay for Plan B's availability without prescription.  [bm]

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