Crawford's Nomination as FDA Administrator to Be Blocked by Democratic Senators After Agency's Delayed Decision on Emergency Con

Main Category: Public Health
Article Date: 08 Apr 2005 - 12:00 PDT

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Democratic Senator Patty Murray (Wash) and Hillary Rodham Clinton (NY) on Wednesday said they plan to block a full Senate vote on... FDA Acting Commissioner Lester Crawford's nomination to head the agency because of FDA's delay in issuing a decision about whether to approve Barr Laboratories' application to allow the emergency contraceptive Plan B to be sold without a doctor's prescription, Reuters reports (Heavey, Reuters, 4/7). FDA in January -- when it was expected to rule on a revised version of Barr's application, which would allow EC to be sold without a doctor's prescription to women ages 17 and older but be dispensed only with a doctor's prescription for girls ages 16 and younger -- announced that the decision would be delayed. On March 17, Crawford in a confirmation hearing told the Senate Committee on Health, Education, Labor and Pensions that FDA would approve the application "within weeks." The agency in May 2004 issued a "not approvable" letter in response to Barr's original application, which would have allowed Plan B to be sold to any woman without a doctor's prescription. The agency based its recommendation on a decision made by Steven Galson, acting director of the FDA Center for Drug Evaluation and Research. However, his decision contradicted the recommendations of two agency advisory panels and cited inadequate data on the use of the pills among girls ages 16 and younger (Kaiser Daily Reproductive Health Report, 3/18).

Crawford Meeting
Murray and Rodham Clinton said they decided to block a vote on Crawford's nomination after a meeting on Wednesday with Crawford and Sen. Edward Kennedy (D-Mass.) that ended "without a commitment" by Crawford about when FDA would make a decision on Barr's application, the Washington Post reports (Kaufman, Washington Post, 4/7). "We had a meeting, and we found it very unsatisfactory," Murray said, adding, "They were unwilling to give us a clear timeline. The FDA is saying they are trying to cross all the t's and dot all the i's on this application because of fear of litigation, which is not a scientific reason to delay approval" (Vieth/Alonso-Zaldivar, Los Angeles Times, 4/7). Immediately following FDA's announcement in January that it would delay its decision on Barr's revised application, the Center for Reproductive Rights filed a lawsuit against FDA in a U.S. District Court in New York, claiming that the agency "did not follow its own procedures or statutory and regulatory mandates when it first denied the application" (Kaiser Daily Reproductive Health Report, 1/24). Despite Crawford's comments last month indicating that Barr's application eventually would be approved, Murray said Crawford was unclear about the fate of the application during Wednesday's meeting, the Post reports (Washington Post, 4/7). Rodham Clinton said she is prepared to continue to block votes on Crawford's nomination "for as long as it takes to get a decision made" about Barr's application, adding, "From everything we're able to determine, the agency has substituted politics and ideology for science and facts." Although Kennedy decided against blocking Crawford's nomination, Kennedy spokesperson Laura Capps said the senator has "conveyed ... that he is hopeful that the FDA will do the right thing and make a decision on this product, and until it is settled he believes it's doubtful Dr. Crawford can be confirmed."

Reaction
White House spokesperson Erin Healy said Crawford, who is a pharmacologist and a veterinarian, is a "well-qualified candidate," adding that the Bush administration "will continue to work with the Senate to ensure his confirmation" (Gay Stolberg, New York Times, 4/7). An FDA spokesperson would not comment on the senators' plans to block a vote on Crawford's nomination, the Wall Street Journal reports (Wall Street Journal, 4/7). Officials from Barr could not be reached for comment, according to Reuters (Reuters, 4/6). According to the Journal, blocking a vote on Crawford's nomination might have "limited impact" because he already is serving as FDA acting commissioner and is expected to eventually win confirmation to head the agency (Wall Street Journal, 4/7). The Senate Health, Education, Labor and Pensions Committee has scheduled a vote on Crawford's nomination for April 13 (Schuler, Congressional Quarterly, 4/6).

"Reprinted with permission from kaisernetwork.org kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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