U.S. senators say FDA still needs user fees

By Susan Heavey

WASHINGTON (Reuters) - U.S. lawmakers on Wednesday said user fees must remain part of the funding mix for the Food and Drug Administration despite calls from some advocacy groups for more federal money instead for the agency that oversees drug safety.

Edward Kennedy, chairman of the Senate Health, Education, Labor and Pensions Committee, said Congress should do more to fund the FDA but added that user fees allow the agency to approve drugs quickly while still addressing possible risks.

"The user fee program ... is an attempt to strike the right balance," the Massachusetts Democrat said at a hearing to weigh the proposal. But Kennedy added it also "demonstrated the failure by Congress to give the FDA funds it needs to do the job that the American pubic counts on it to do."

Industry user fees, first enacted in 1992, give the FDA millions of dollars annually to review new products for the U.S. market but are set to expire in September.

Under a 5-year proposal to continue the fees, drugmakers would pay the agency about $393 million in fiscal year 2008. The FDA requested a total budget of $2.1 billion for the same year, including the fees.

Some critics contend the drug companies' user fees influence the agency, which is supposed to protect consumers' health and safety.

FDA Commissioner Dr. Andrew von Eschenbach said agency staffers were not swayed by the fees and made scientific decisions. "They are specifically intended to be fee-for-service," he told lawmakers.

Other groups less critical of the fees say they simply aren't enough to allow the agency to keep pace with rapidly changing science and technology.

"An investment in FDA is long overdue," the FDA Alliance said in a letter to the committee, adding the agency needs $2 billion in federal funds alone for 2008 in addition to fees.

Ranking Republican Sen. Mike Enzi of Wyoming, who agreed that Congress should reexamine its FDA funding levels, also expressed doubts. "I'm not convinced that greater appropriated funds would solve all the FDA's problems," he said.

The fee program's renewal also comes amid renewed focus on safety, sparked by the withdrawal of Merck and Co. Inc.'s arthritis drug Vioxx in 2004. The FDA's handling of antidepressants and other products has also faced scrutiny.

Lawmakers are considering whether to use the funding bill to attach other safety-related provisions.

Kennedy and Enzi have introduced separate legislation to give the FDA additional safety powers, such as requiring clinical trials after a drug hits the market. Currently, the agency can request such studies but cannot ensure drugmakers conduct them.

Still, consumer advocates said the senators' safety bill does not go far enough.

"The range of fines established in the bill would not be even a slap on the wrist if applied to a blockbuster drug with sales in the billions," the Center for Science in the Public Interest, the National Research Center for Women & Families and other groups wrote the committee.

Other Senate lawmakers, including Connecticut Democrat Christopher Dodd and Iowa Republican Charles Grassley, have also introduced competing safety proposals.