12:01 A.M. ET
Tuesday, October 18, 2005


Jon Gardner,


Health Affairs Article Proposes Increase In FDA User Fees To Finance Drug-Safety Analyses

Article Argues That Recent Drug Withdrawals And Warnings
Demonstrate Need For Funding Of Surveillance Once Drugs Are Approved

The federal government should raise the user fees paid by pharmaceutical manufacturers to the Food and Drug Administration (FDA) to help finance safety studies once a drug has hit the market, according to a new article published today on the Health Affairs Web site.

Daniel Carpenter, professor and director of graduate studies in Harvard University’s Department of Government, writes that the reputations of both the pharmaceutical industry and the FDA could be revived if Congress creates dedicated funding for postmarketing studies of approved drugs and analyses of the health impacts of long-term use of drugs used to treat chronic conditions.

The safety reputation of the drug industry and the FDA has been damaged by the withdrawal of the arthritis drug Vioxx, warnings about a connection between certain depression drugs and teenage suicides, and connections between estrogen replacement therapy and endometrial cancer, Carpenter says.

An increase in the user fees paid for new drug applications would give FDA the money it needs to conduct comparative randomized controlled trials for widely used drugs that treat chronic conditions; purchase more and better epidemiological data; and improve its epidemiological surveillance infrastructure.

“A large number of recent complaints about drug regulation are aimed at a perceived ‘imbalance’ at the FDA,” Carpenter says. “Prominent observers have lamented that the user-fee system is tilted too much toward the approval of new medicines and not enough toward their safety. If an augmentation proposal does nothing else, it will specifically, formally, and publicly commit tens of millions of dollars per year to safety-related studies and surveillance.

“And as the funded studies make their way into academic, public, and regulatory discussions, the public will increasingly recognize the contribution of augmented and safety-directed user fees,” Carpenter says.

A 25 percent increase in the user fees would add $42 million to FDA coffers to fund safety work but would represent less than one-hundredth of 1 percent of average drug development costs, Carpenter says. Using half of that amount would allow the FDA each year to launch three to seven randomized control clinical trials of the long-term impacts of drugs used to treat chronic condition.

“Just pick the drugs that we are most worried about, and with this policy reform in just three to five years, all of those drugs will be under long-term, comparative, randomized and controlled study,” says Carpenter of his proposal.

Although some segments of the pharmaceutical industry may oppose the proposal, Carpenter says that the precedent exists in current law to fund postmarketing studies from user-fee dollars, and he adds that an increase backed by a drug safety justification could be the “political price” for reauthorizing the user-fee law, which the industry supports in general.

To satisfy consumer advocates who see the user-fee law as a way to speed products to market without proper clinical studies, Carpenter proposes that an FDA advisory committee or some other independent institution recommend how the money should be used when examining postmarketing drug safety.

The article can be read at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.469.

Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears bimonthly in print with additional online-only papers published weekly as Health Affairs Web Exclusives at www.healthaffairs.org. The full text of each Health Affairs Web Exclusive is available free of charge to all Web site visitors for a two-week period following posting, after which it will switch to pay-per-view for nonsubscribers. The abstracts of all articles are free in perpetuity. Web Exclusives are supported in part by a grant from the Commonwealth Fund.

©2005 Project HOPE–The People-to-People Health Foundation, Inc.