Senate Rejects Limits on FDA Waivers, Then Passes Extension of User Fees

An amendment that would allow just one scientist with a conflict of interest to serve on a Food and Drug Administration advisory committee went down to a narrow defeat Wednesday. The vote on legislation offered by Senators Richard Durban, Jeff Bingaman and Barack Obama (the presidential candidate became a sponsor on Tuesday) was 47-47, with prominent Democrats like Sen. Ted Kennedy (D-MA), John Kerry (D-MA) and Christopher Dodd (D-CN) voting against the bill. Tie votes on amendments do not pass, according to Senate rules.

An amendment by Sen. Charles Grassley that would give greater voice to the FDA's safety division also went down to a narrow defeat. However, the Senate add stronger civil penalties to the bill.

After the conflicts of interest amendment went down to defeat, the reauthorization of drug user fees, which are used to speed the approval of industry's new drug applications, passed the full Senate with just one dissenting vote. That drew a heated reaction from Peter Lurie of Public Citizen, the safety watchdog group that closely monitors the FDA.

"It is a fundamental conflict of interest to have an industry be able to dictate to an agency the speed at which reviews will take place," Lurie told the Washington Post. "And yet that's exactly what happens and nobody challenged that in a fundamental way."

While there are some minor improvements in drug safety programs at FDA contained in the bill, the Senate in recent days rejected limits on direct-to-consumer advertising and refused to allow Americans to import drugs from Canada. Researchers will get better access to clinical trial data that companies submit to the agency, and companies will have to spell out their risk management plans for drugs with significant side effects that get approved by the agency.

The bill now moves to the House, where companion legislation sponsored by Henry Waxman (D-CA) and Edward Markey (D-MA) has conflict-of-interest language comparable to the bill that just passed the Senate. A number of representatives have indicated strong interest in authoring a total ban on scientists with conflicts of interest serving on FDA advisory committees.