Giant Awakening?

FDA: A

October 05, 1991

Important questions remain about the Food and Drug Administration, despite the aggressive approach its new commissioner, Dr. David A. Kessler, has taken on truth-in-promotions. The first has to do with efficiency, a buzzword during the Reagan-Bush years.

It has been well documented that approval of new pharmaceuticals drags. In the competitive environment in which American manufacturers find themselves, that means new products often get introduced abroad before U.S. approval can be won, even if the drugs were developed by domestic firms. That's not all bad; Thalidomide and other products were found to be harmful long before they went into wide use here.

Still, a regulatory process that slows introduction of useful products so badly that it diminishes the practical benefits of patenting them cannot be much of a boon, either. It could inhibit development of some products long enough to make them uneconomic propositions. In desperate situations such as the AIDS epidemic, the FDA has had to come up with accelerated programs to bypass its own cumbersome drug-approval process.

Can a resurgent FDA, moving ahead with the backing of the White House, press on with new technology to match the dazzling developments of today's recombinant DNA labs and pharmaceutical houses? Can it speed its evaluation yet preserve safety for the public? Can this be done when the budget deficit is forcing a downsizing of many other federal agency activities?

There are also questions about the FDA's staying power. Dr. Kessler's impressive credentials and political backing appear to give him a clear course through the minefields laid by corporate powerhouses whose chiefs are major backers of Mr. Bush. But how committed is the administration to the difficult task of policing food-products companies, cosmetics makers, pharmaceutical and chemical companies when these firms are constantly harping on the "competitiveness" factor in American markets from Europe and the Pacific Rim?

As one FDA critic has noted, the current truth-in-labeling crusade came about because lax enforcement had allowed things to get out of hand. Correcting that laxity is a service, to be sure, but the real tests still lie ahead for Dr. Kessler.

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