VON ESCHENBACH DEFENDS FDA POLICIES, PROPOSED BUDGET

FDA Commissioner Andrew von Eschenbach made his second appearance in two days before Congress to support the agency's proposed 2008 budget, but he also had to defend the agency's handling of Ketek and other controversial topics.

Von Eschenbach responded to criticism over user fees, direct-to-consumer (DTC) advertising and conflicts of interest in advisory committees at a House Agriculture, Rural Development, FDA and Related Agencies Appropriations Subcommittee hearing Feb. 28.

The agency's proposed budget includes three new user fees that would generate $42.7 million, but Chairwoman Rosa DeLauro (D-Conn.) questioned whether the agency should rely less on user fees and more on appropriations. The proposed budget does not appear to fully fund the FDA's needs, DeLauro said, leaving user fees to make up the difference.

User fee critics say the payments allow the industry to have too much influence over the agency. However, the user fees are "compartmentalized" and do not affect the FDA's decisions, von Eschenbach said.

He was also challenged on the agency's use of advisory board members with conflicts of interest. Rep. Maurice Hinchey (D-N.Y.) accused the agency of not trying to find people without conflicts of interest, adding that several drugs, including Ketek, would not have been approved if not for the vote of a person with a conflict. The FDA is issuing guidances to improve the advisory committee process and has broadened its access to experts, von Eschenbach said, but Hinchey was not appeased.

The approval of Ketek put many people in jeopardy, Hinchey said. At a recent House subcommittee hearing, former FDA employees testified that the agency ignored safety risks to rush the antibiotic to market and that the agency discouraged dissent in the drug review process.

In addition, members of the subcommittee at this week's hearing questioned a proposed budget increase that would add 27 staff members to review DTC advertising. Simply adding more staff will not be sufficient to control companies, DeLauro said.

( http://www.fdanews.com/did/6_43/ )