18 février, 2007 23:39
FDA commissioner defends fees from drugmakers
By Lisa Richwine
WASHINGTON (Reuters) - The head of the U.S. Food and Drug Administration defended the industry fees that help fund drug reviews on Friday, saying the money from manufacturers did not sway decisions in their favor.
Congress will consider this year whether to renew the program, which started in 1992. The fees have dramatically cut drug review times by allowing the agency to hire more staff. But critics say the money makes scientists work to please companies instead of doing what is best for the public.
FDA Commissioner Andrew von Eschenbach said the source of the funding does not impact how FDA scientists make decisions. The fees supplement money from taxpayers.
"No one is buying the FDA," von Eschenbach said at a meeting to gather public input on the program.
"The FDA knows that our actions and our decisions require adequate resources," he added. "We are not focused on where the resources come from, but only the purpose for which those resources are in fact necessary - to protect and promote the health of the public we serve."
The agency and the drug industry have negotiated a proposal that would increase company fees, use more of the money for drug-safety monitoring and for the first time devote funds to reviews of drugmakers' television commercials.
Lawmakers should start considering that plan in spring and pass a bill before the current program expires in September.
A consumer group said the fees were having a "corrupting influence" and "putting products before American consumers with outstanding safety issues."
"Many (FDA employees) are feeling, if not bought, pressured" by the industry, said William Vaughn, senior policy analyst for Consumers Union.
The FDA's work is so important to the public that it should be fully funded by taxpayers, he said. If the fees remain, the agency should provide firm goals for safety efforts, he added. For example, the FDA could commit to requiring studies for a certain number of unapproved uses of medicines each year.
The Pharmaceutical Research and Manufacturers of America, an industry lobbying group known as PhRMA, said companies and patients had benefited from a quicker, more predictable process that resulted from the fees.
With the fees, the FDA has goals for completing most reviews in specified timeframes. Reviews took about 30 months before the fees were imposed, and now the medicines considered most important are analyzed in six months or less.
"FDA has been able to complete its rigorous reviews more quickly and more efficiently. The outcome is not at all affected by (industry) funding. That decision is FDA's and FDA's only," said Alan Goldhammer, PhRMA's deputy vice president for regulatory affairs.
