By Kim Coghill
WASHINGTON ¿ Michael Astrue, a senior vice president of Transkaryotic Therapeutics Inc. (TKT) who was rumored to be President Bush¿s top candidate for FDA commissioner, confirmed Thursday that he has withdrawn his name for consideration.
Astrue would not discuss details that led to his decision, except to say he officially withdrew Tuesday.
It has been reported that Sen. Ted Kennedy (D-Mass.), chairman of the Senate Health, Education and Labor Committee, which oversees the FDA, opposes any candidate from the industry. According to the Boston Globe, Kennedy said he would not hold hearings for Astrue.
Kennedy¿s office in Boston referred questions to the Washington office, which could not be reached for comment.
The newest candidate on the short list is Lester Crawford, a veterinarian who heads Virginia Tech¿s Center for Food and Nutrition Policy in Alexandria, Va. Crawford is a former administrator with the U.S. Department of Agriculture and the FDA. When reached by phone, Crawford would not comment on whether he is being considered.
Others on the list are Eve Slater, a senior vice president at Whitehouse Station, N.J.-based Merck and Co.; Lynn Drake, a dermatologist with ties to the Republican Party; and Richard Pazdur, of the FDA¿s cancer division. Astrue is the senior vice president of administration and general counsel for Cambridge, Mass.-based TKT, and chairman of the Massachusetts Biotechnology Council.
In congressional business, in a 91-5 vote last week, the Senate passed a $73.9 billion Fiscal Year 2002 Agriculture Appropriations Bill that did not include any form of a drug reimportation amendment.
From here, the bill heads to a House-Senate conference, where it will meet up with a $74.3 billion House version. Approved July 11 in a 324-101 vote, the House bill includes a reimportation amendment introduced by Rep. Gil Gutknecht (R-N.M.) that prohibits FDA money from being used to police the reimportation of U.S.-approved prescription drugs from foreign countries.
Gutknecht¿s amendment allows reimportation by an ¿individual who is not in the business of reimporting prescription drugs,¿ as long as such products are not regulated or controlled substances.
Earlier this year, the Biotechnology Industry Organization said it¿s concerned that approval of such an amendment would create ¿open season¿ on the flow of counterfeit and potentially dangerous prescription and biotechnology drugs into the U.S.
Reimportation legislation was approved last fall as part of the Fiscal Year 2001 Agriculture Appropriations Bill and was signed by former President Bill Clinton. But Donna Shalala, Clinton¿s secretary of Health and Human Services, failed to implement the legislation because she could not demonstrate that it was safe or that it would reduce costs. (See BioWorld Today, Oct. 2, 2000, and Dec. 29, 2000.)
The original intent of the legislation was to provide cheaper prescription drugs to the elderly and anyone else looking for a bargain.
In other business in Washington on Thursday, the Senate continued its debate on the Fiscal Year 2002 spending bill for the Department of Health and Human Services. But in an effort to compromise late in the afternoon, Sen. Sam Brownback (R-Kan.) pulled his amendment that would have banned therapeutic cloning. The House approved an amendment earlier this year that criminalizes therapeutic cloning.