Magazine article Management Review

The FDA: Cost versus Safety

Magazine article Management Review

The FDA: Cost versus Safety

Article excerpt

Laden by bureaucracy, this Byzantine federal agency is too cumbersome to operate in a high-speed world. Yet its role is integral in consumer protection.

Since it was first constituted by the Pure Food and Drug Act in 1906, the Food and Drug Administration has operated as one of the most independent, and byzantine, of all of the federal bureaucracies. It has had a long time to build this bureaucracy, as one of the oldest federal regulatory agencies. Even its geographical location, outside the nation's capital, on its own isolated suburban campus, sends the same message. It will do whatever its scientists, lawyers and bureaucrats feel is right, with only the barest nod to the federal government downtown.

No more. Suddenly, the FDA is feeling the hot winds of change breathing down its neck.

The change is in the form of congressional legislation from change that is suddenly taking on very much a life of its own. Back in March, James O'Hara, the FDA's deputy commissioner for public affairs, was saying rather confidently, "We don't really take any of this Republican legislation very seriously." A month later, it was a whole different ballgame. Now, suddenly, the legislation "doesn't address the problems." That's how Bill Schultz, deputy commissioner for policy of the FDA, puts it when pressed on his view of the legislative measures that began working their way through the House and Senate in somewhat different forms early this year.

"The House legislation would mean that a large part of the FDA, a large part of its functions, would be performed by private organizations, in many cases paid for by the industry" says Schultz. It would be, say he and other FDA officials from Commissioner David Kessler on down, the very worst of all possible worlds.

Not so for any of the various industries the FDA regulates. Not so for many consumers of the products the FDA governs. Certainly not so for the sponsors of the legislation. They think reform of what seemed like endless processes of review and comment before a new drug or medical device can get on the market is long overdue.

"We are really at the dawn of discovery when it comes to the biotech industry," says Representative James Greenwood, a second-term Pennsylvania Republican. "We are approaching a real ability to fight disease on the molecular level. And there are millions of Americans suffering from AIDS, cancer, juvenile diabetes, coronary artery diseases. And between the research laboratories and the patient stands the FDA. They do a very good job of making sure a product does not reach the consumer unless it is safe and effective. They don't do such a good job when it comes to getting products to the consumer expeditiously."

The bill Greenwood has sponsored, "The Drug and Biological Products Reform Act," and its Senate counterpart spearheaded by Senator Nancy Kassebaum (R-Kan.), who chairs the Senate Labor and Human Resources Committee, are designed to address this particular problem that cuts to the heart of reforming the 9,000-employee FDA.

"The image I prefer is that of a sailboat" says Dr. John Beery, senior vice president for regulatory and scientific affairs of the Pharmaceutical Research and Manufacturers of America, one of the industry's leading trade associations pressing for reform of the FDA bureaucracy. "Every so often, you have to scrape off the hull. It doesn't mean you have to kick a hole in it."

The problem these Republican-sponsored measures are seeking to address is one of the longest-standing dilemmas of the federal government. How does one make certain that a new food, drug or medical device is both safe and effective--the two principal criteria for licensing such products for sale or distribution? Until very recently, the method was a long and laborious process of laboratory tests, clinical trials and reviews of the results by panel after endless panel. At times years, even decades, would pass before a product could make its way from the labs to the drugstore shelves. …

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