Washington Editor

WASHINGTON - FDA Commissioner Andrew von Eschenbach defended accusations of drug industry influence on the agency at a congressional hearing last week, an event principally related to renewing the Prescription Drug User Fee Act that funds much of the FDA's drug-review activities.

"I view user fees to be a service to the American people, not a service to the FDA or the industry," he testified before the House Energy and Oversight Subcommittee on Oversight and Investigations, part of the Energy and Commerce Committee. "[They're designed] so that drugs can be more efficiently reviewed and understood with regard to their expected benefit and their expected risk, and the sooner you bring them to the American people . . . serves [the public] best."

Despite that assurance, numerous members maintained that the user-fee program has at least fed negative perceptions of a cozy relationship between the FDA and drugmakers, if not fostered it in reality. In fact, Subcommittee Chairman Bart Stupak (D-Mich.), who accused von Eschenbach of inaccurate testimony, requested that the FDA provide transcripts of PDUFA negotiations between agency officials and drug industry representatives, which took place throughout last year.

"We want to see what input drug companies had in the process," he said. "There's no proprietary interest in those negotiations."

In addition to criticizing the user-fee program, several subcommittee members indicated their preference for further empowering the agency to more strictly regulate drugs once they're on the market, suggestions that speak to an underlying drive in both chambers of Congress to certify the FDA's post-approval controls as clearly as its pre-approval powers.

That push is being made in concert with reauthorizing PDUFA. In particular, several said the agency should have clear authority to mandate post-approval studies, as well as more options to punish noncompliant companies, definite power to make label changes without industry negotiations, firm advertising controls upon new drug launches and better restrictions on potentially risky drugs.

"Beyond a shadow of a doubt," said Rep. Henry Waxman (D-Calif.), "FDA drug safety oversight is in serious need of repair."

Further criticism was levied on von Eschenbach himself over accusations that he has fostered an intra-agency climate that suppresses FDA staffers from expressing dissent on product reviews, charges that he tried to fend off throughout the hearing. Nevertheless, Rep. John Dingell (D-Mich.), the chairman of the full committee, requested that von Eschenbach provide a copy of a November communiqué to FDA staffers encouraging them to speak openly with congressional members, without fear of impunity.

Agency To Further Restrict Advisers

The FDA is tightening eligibility rules for advisory committee members per a new draft guidance issued last week, specifically to address potential financial conflicts of interest in companies that could be affected by advisory meetings.

Among the proposed restrictions, individuals generally would not be allowed to participate if their disqualifying financial interests exceed $50,000, and if their disqualifying financial interests were less than that amount, they would have limited eligibility to participate in a nonvoting capacity. In addition, the agency intends to generally limit participation in certain cases in which there may be a perception of a conflict of interest, even though full participation would be permitted under the applicable statutes.

The FDA is accepting public comments on the proposal for the next 60 days.

Bush Stem Cell Policy Questioned

NIH Director Elias Zerhouni recently spoke out against federal restrictions on embryonic stem cell research during a Senate subcommittee hearing on appropriations.

His comments were applauded by Sen. Tom Harkin (D-Iowa), the chairman on Senate Appropriations Committee's Subcommittee on Labor, Health and Human Services, and Education and Related Agencies. Harkin, an outspoken advocate on the issue, added that he hopes Zerhouni's words resonate within the White House.

The hearing also was a platform for those critical of stagnating funds for the NIH. Among them were a number of scientists from leading academic institutions who issued a report detailing a decline in U.S. biomedical research because of consecutive years of flat budgets, causing promising research to be halted early and leading young investigators to explore careers outside science, in addition to other problems. That is in stark contrast to the doubling of the NIH's budget between 1998 and 2003, an argument also made by many others in the research community these days.

Amgen Boss Retains PhRMA Chair

Amgen Inc.'s president and CEO, Kevin Sharer, was re-elected chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA) at the trade association's recent annual meeting. Sharer, who initially stepped into the role in September, said the drug industry's policy priorities over the next year would focus on ensuring patient access to breakthrough medicines without dampening innovation.