User Fees for Faster Drug Reviews? : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

An Independent Review

A major concern focuses on the perceived impact of industry money, and there are some who express apprehension about the arrangement. In its report from the Government Performance Project in March 2000, the Maxwell School of Public Administration at Syracuse University concluded that the "emphasis on speed of industry-funded drug reviews raises concerns."

Some critics have publicly worried that making the agency dependent on company funding diminishes the agency's independence and objectivity. In short, they think FDA is in the industry's pocket. Wolfe's group, for example, argued before Congress that funding FDA's drug reviews with industry money has "lowered U.S. drug safety standards, arguably once considered the world's best, to pre-1938 levels [before] the Food, Drug and Cosmetic Act was passed."

FDA does not believe that review criteria have been compromised, but understands that this is a perception problem, one it hopes to confront at the September meeting.

No matter what the perception about the funding source, the agency believes it has made the drug and biologics review process more efficient without lowering drug review standards. But that claim, too, has been controversial. In the 10 months between September 1997 and June 1998, FDA directed the withdrawal of five approved pharmaceuticals from the market because of unexpected, severe adverse events. The withdrawn drugs included a diet drug combination, a calcium channel blocker for treating hypertension and chronic stable angina, a non-steroidal anti-inflammatory drug, and a once-widely used antihistamine. Some of these were approved before user fees.

Agency critics point to this spate of drug withdrawals as evidence that the accelerated reviews under the user fee program have led to sloppy analyses and increased risk to the public. To determine whether the agency was "maintaining adequate quality control over its premarketing review decisions," Henney established a task force in 1999 to investigate the concern. By comparing a General Accounting Office study of drugs approved before 1990 with new pharmaceuticals approved under the user fee system between 1994 and 1997, the task force concluded "that there has been no increase in the rate of drug withdrawals in the United States" since the user fee program began.

As much as anything, the need to remove some drugs from the market after they go into widespread use reflects the limitations of the clinical studies on which drug approvals are based. Typically, new pharmaceuticals are tested in less than 5,000 human volunteers during development. That provides enough information to identify fairly common side effects, but does not turn up the rare, but sometimes severe, adverse effects seen only when millions of people use the drug. The agency relies on its post-market surveillance system to identify these uncommon side effects. When a problem is discovered, FDA can take a wide range of actions to protect the public health, from notifying health-care professionals about the problem or changing the instructions on how the drug should be used, to, in very serious cases, removing it from the market.

A Balanced Budget

Congress created FDA's user fee program to help solve the agency's chronic resource shortages. In the 1992 version of the act, neither Congress nor the industry envisioned user fees becoming the principal source of funding for the FDA drug-review program. In fiscal year 2000, for the first time, that may change: user fees and appropriated dollars are approaching equilibrium, and that concerns Commissioner Henney. (See "Growth of User Fees to Support Drug Review.")

"There is a feeling that the public will not tolerate having the drug review program more than 50 percent user fee-funded," Henney says. "Others say that the fact that industry funds any of it is bad."

Part of the problem has been overall congressional appropriations: they haven't kept pace. "FDA is not receiving appropriated dollars to balance PDUFA dollars," says Robert Byrd, FDA's deputy commissioner for management and systems. "Congress has increased agency funding amounts, but only for specific initiatives. FDA has lost roughly $200 million over the past six years because of having to absorb inflation and pay raises that have not been funded." Because funding failed to keep up, the agency has actually lost people because it was forced to reduce some of its staffing to cut costs.

"We share a concern with FDA about the current balance between the user fee portion and the appropriated portion of the review process," PhRMA's Goldhammer says. As industry funding approaches half of the review budget, "it has led to a perceptual issue that industry is paying for the review process and that the American public, through its tax moneys, is not. We would hope that can be dealt with in some way because we don't want there to be the perception that this is an industry-driven program."

Wolfe's solution to the perception problem is simple: Eliminate user fees. "If industry really wants FDA to have an adequate budget," he says, "it should lobby hard for a greatly expanded FDA budget through the normal congressional appropriations process."

Balancing revenue streams between public and private sources, however, does not cause everyone heartburn. In some other countries, all drug regulation costs are funded by industry. And in the United States, regulatory agencies as diverse as the Nuclear Regulatory Commission, the U.S. Patent and Trademark Office, and the Securities and Exchange Commission receive all, or nearly all, of their funding from regulated industries.

"We are not the only government agency that relies on user fees," says FDA Senior Associate Commissioner Linda Suydam, D.P.A. "But the question is, does that in any way jeopardize FDA's integrity and independence? We have no evidence of this, but we are using the public meeting to make sure it doesn't. We want everyone to engage in the public debate."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.