FDA Commissioner Lester Crawford, who served as acting commissioner from March 2004 until his confirmation earlier this month, told the House Appropriations... Subcommittee on Agriculture, Rural Development, FDA and Related Agencies on Tuesday that he was justified in granting bonuses to senior FDA employees in 2004, in part because the agency had received increased funding from HHS that year, the Boston Globe reports (Henderson, Boston Globe, 7/27). Crawford approved $511,025 in cash bonuses for career senior FDA executive service employees in 2004, compared with $161,994 approved in 2003 by former agency Commissioner Mark McClellan (Kaiser Daily Health Policy Report, 7/26). Crawford said another reason for the increase during his tenure was that previous caps on the number of employees who could receive the bonuses had been lifted (Boston Globe, 7/27).

Drug Labeling
Crawford also defended FDA's actions in handling labeling changes on the prescription painkiller Vioxx, a Merck drug that ultimately was removed from the market over safety concerns last year. In response to criticism from committee members that negotiations with Merck on the label change went on for 14 months after Vioxx was shown to have adverse health effects, Crawford said, "When we ask these companies to voluntarily change their labels, we have little difficulty getting them to do it" (Hunter, CQ Today, 7/26). Crawford said he will not push for FDA authority to force drug companies to change labels or to demand postmarket studies. He said, "I'm open to discussions, but we have no administration position on that." Rep. Rosa DeLauro (D-Conn.), the subcommittee's ranking Democrat, said, "We believe you need this authority" to demand label changes, adding, "If you don't, that calls into question what kind of management ... and what direction the agency is going" (CongressDaily, 7/27).

Communication
Several subcommittee members said they had received little or no response from FDA to written requests for information they had sent the agency. Subcommittee Chair Henry Bonilla (R-Texas) told Crawford, "I would strongly suggest that there be a new attitude about getting back to members promptly." Crawford originally was scheduled to testify in March, but his testimony was rescheduled because the Bush administration was reluctant to let him go before the subcommittee before he was confirmed as commissioner, CQ Today reports. In June, DeLauro attached an amendment to the House Agriculture appropriations bill to withhold 5% of FDA's budget until the commissioner appeared before the subcommittee to respond to inquiries about budget requests and other issues.

Drug Reimportation
Rep. Jack Kingston (R-Ga.) asked Crawford if the subcommittee should study the safety of drug reimportation from Canada (CQ Today, 7/26). Subcommittee members also asked if FDA needed more funding to monitor the safety of reimported drugs (Boston Globe, 7/27). Crawford replied that the administration opposes drug reimportation and that supporting a study on its safety would be a "contradiction" (CQ Today, 7/26).

Additional Testimony
Crawford said naming a director of the agency's Office of Drug Safety was one of his top priorities and that the position should be filled by the end of September. The naming process "took longer than it should have," he said, adding, "Some of it was our fault. It fell through the cracks." In addition, Crawford said FDA has been working regularly with the Department of Homeland Security, FBI and CIA to "stay ahead of the criminal mind" in order to protect the nation's drug supply from terrorists. He said terrorism "is a major concern for us" (Boston Globe, 7/27).

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View drug information on Vioxx.