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FDA User Fees Is Rx To Speed Drug Approvals

July 05, 2007

By David Gratzer

The House of Representatives begins consideration this month on legislation that has previously enjoyed bipartisan support, affects part of the budget of one regulatory body and continues a strategy first implemented 15 years ago. Sounds noncontroversial?

But since the agency involved is the FDA and the idea is user fees for companies seeking product approval, congressional action faces strong opposition. Washington must focus on the task at hand: working to get drugs approved in a timely manner. That means ignoring hot rhetoric and building on the cool success of the last decade and a half by renewing the Prescription Drug User Fee Act (PDUFA).

While the idea of the act is simple enough — by raising extra funds, the FDA can hire added staff to expedite the approval process for pharmaceutical and biotech products — it has become a lighting rod for criticism.

The New York Times calls PDUFA "dangerous." Four previous commissioners of the FDA and three previous editors of the New England Journal of Medicine have all expressed misgivings, as have members of the prestigious Institute of Medicine.

Critics, like Dr. Sidney Wolfe of the Public Citizen, denounce it, claiming user fees create a conflict of interest. "When the FDA views the drug companies as their client," Wolfe recently said, "it erodes the adversary relationship. It changes it from being a regulator to being a collaborator."

Some have gone further, suggesting that American lives are put in peril. Writing in the New England Journal of Medicine, Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, explains: "Drugs are being rushed through, not getting the attention they deserve."

But in all the criticism, there is little analysis. PDUFA does not strangle the FDA of needed funds, leaving the agency desperate to please the companies it's supposed to regulate to shore up a bit of cash. The FDA receives set user fees at the beginning of drug reviews. PDUFA, in other words, is not pay-for-play, with no conflict of interest.

Many other government agencies use user fees — and no one thinks twice. Motorists pay to drive on toll highways but are they then able to get the governor on the phone? After dropping a few quarters, are they exempted from highway speed limits? User fees are common: for driver's licenses, postage, passports, patent applications, business registration. Whole industries are regulated this way, like the FAA and the airlines.

FDA critics are long on insinuations but short on data. PDUFA was introduced when Bill Clinton was new to the national scene and Michael Jordan dominated basketball. Yet critics can't illustrate the realization of their doom and gloom scenarios.

And a quick look at the data suggest why. Since implementing user fees, the number of annual drug withdrawals has remained unchanged. The drugs in our pharmacies are no less safe than 15 years ago.What has dramatically changed is approval times: During the 10 years after the law was enacted, the average time decreased from 27 months to 10.5 months.

That isn't simply statistically interesting, it's literally a lifesaver. The University of Chicago's Tomas Philipson and his co-authors estimated in a 2005 National Bureau of Economic Research paper that 180,000 to 310,000 lives were saved since 1992 by the faster approvals.

Just as the drafters of PDUFA predicted, drugs complete their FDA analysis earlier. For patients suffering from cancer or heart disease or many other ailments, it means that newer meds reach them sooner.

PDUFA is not perfect. The FDA is a slow, bureaucratic organization. By allowing user fees, Congress has, to some extent, pushed off more fundamental reforms. Absent from the debate over PDUFA is a broad reconsideration of the approval process.

Here is where Congress can step in. Back in the early 1990s, the FDA experimented with a simple idea: relying on not-for-profits to help with the process of reviewing drugs. At first glance, the idea seems controversial since we would be trusting important decisions to nongovernment employees. But Americans already do this for many consumer products — consider that the lamp sitting on your desk and the fire extinguisher in the hall were inspected by Underwriters' Laboratories.

Why not use such organizations to help facilitate (and ultimately hasten) drug reviews? When the FDA used Mitre Corp. for this task, its reviewers reached the same conclusions as government officials — but in a fraction of the time. If the Air Force can trust contractors to build our jets, surely the FDA can tap non-FDA scientists.

So Congress can do something this summer to help American medicine: re-approve FDA user fees, with an amendment promoting further experimentation with not-for-profit reviewers. It would be a prescription for better health.

Original Source: http://www.ibdeditorials.com/IBDArticles.aspx?id=268519353497161

 

 
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