Healthy Skepticism Library item: 7723

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Publication type: news

Mathews AW.
FDA Change May Begin With User Fees
Wall Street Journal 2007 Jan 12
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Full text:

WASHINGTON — The Food and Drug Administration’s deal with the pharmaceutical industry about user fees that companies pay the agency to review their products will likely prove a starting point for broader FDA-reform efforts backed by congressional Democrats.
The pact, unveiled yesterday, allows for substantially increased payments to the FDA, with more money allotted for monitoring the safety of medicines after they go on the market and a new fee for agency reviews of consumer television ads. Most of the money for the FDA’s drug-review process comes from such fees.
Congress must approve the five-year deal before it can take effect, and while the drug industry will press for a user-fee bill without major additions, lawmakers are likely to consider far bigger changes that could result in new authority and responsibilities for the FDA. The confluence of must-pass FDA legislation including the user-fee reauthorization, and the takeover of Congress by Democrats, who are more inclined to take a tough stand against the drug industry, means major adjustments to the FDA have a better shot at passing this year than anytime in at least a decade.
The FDA plans to hold a public meeting next month on the fee arrangement. Steven Galson, the head of the agency’s drug center, said the new deal would “significantly broaden and upgrade our safety program.”
Fee funding in the first year of the new deal would amount to about $393 million, not including adjustments made when the FDA’s workload rises. That is up from $305 million in fiscal 2007 before the workload adjustment. About $30 million of the increase would be used for drug-safety issues.
Separately, the FDA and industry are proposing a new fee — totaling about $6.25 million a year, plus more the first year to establish a reserve — that drug makers would pay for the FDA to review their television ads. Companies submit such ads voluntarily.
The drug companies won some changes they hope will smooth the FDA review process, including an agency promise to provide a projected timeline to review new-drug applications.
Senate health-committee Chairman Edward Kennedy (D., Mass.) and ranking Republican Michael Enzi of Wyoming said they will work to “implement and, where necessary, strengthen these proposals.” Republican Sen. Charles Grassley of Iowa said the FDA needs “comprehensive reform.” Sen. Herb Kohl (D., Wis.), who chairs the appropriations subcommittee that oversees the FDA budget, said he was “pleased” by the safety money but had “several questions about whether or not a user fee is the best way” to add to the FDA’s ad-review resources.
Rep. Rosa DeLauro (D., Conn.), who chairs the equivalent House subcommittee, said despite concerns about the fee program, she will work on “developing a proposal that will create an effective drug-safety system.” Rep. John Dingell (D., Mich.), who chairs the House Energy and Commerce Committee, said he plans to review the details and talk to stakeholders before taking a position.
Write to Anna Wilde Mathews at anna.mathews@wsj.com1