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FDA Nominee to Get Vote; Agency to Act on Plan B Pill

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Grassley, who has been highly critical of the FDA's record on drug safety issues under Crawford, asked for an individual breakdown of which top officials received bonuses over the past five years.

Rep. Rosa L. DeLauro (Conn.), ranking Democrat on the House committee that oversees the FDA budget, earlier asked the FDA for information about bonuses and travel by high-ranking officials.

In a written response, FDA said its employees received a total of $19.6 million in bonuses from Jan. 1, 2003, to April 16, 2005, including more than $840,000 to the SES employees. There are 44 SES employees with lifetime positions in the 10,000-employee agency.

"This agency has claimed repeatedly to not have the budget resources necessary to do its job -- providing drug safety reviews and oversight of advertising for these drugs," DeLauro said. "You shouldn't put someone with questionable management practices into an agency that has existing management problems."

In answer to questions from DeLauro about travel, the agency also detailed trips taken since Jan. 1, 2003, by 25 top agency officials. Included in those records are details about five trips that Bond took with Crawford. The purpose for the trips was listed as "staff support to Dr. Crawford."

The agency's inspector general also investigated allegations that Crawford improperly promoted Bond and concluded that officials had conflicting recollections of how and why she was promoted to the Senior Executive Service.

The FDA and inspector general's office declined to comment about any inquiry regarding FDA employees and their travel.

Leavitt's statement that the Plan B application will be acted on by Sept. 1 was welcomed by women's health advocates, who said a decision is overdue.

"President Bush's FDA has 46 days until they must decide whether to side with the doctors and scientists who overwhelmingly support giving women over-the-counter access to the pill or, once again, cave in to the anti-birth-control radical right," said Nancy Keenan, president of NARAL Pro-Choice America. "The 'morning-after' pill is a safe, effective way to help women prevent unintended pregnancies."

But opponents of Plan B said the drug -- a concentrated form of the normal birth control pill -- should be treated carefully.

"The FDA has been right to be resistant," said Wendy Wright, senior policy director for Concerned Women for America. "It's a bizarre precedent that's been proposed -- making the high dose of a drug easily available when a low dose requires a prescription." She said efforts to restrict the use of emergency contraception will continue whether the FDA approves it for nonprescription sale or not.


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