IS IT POSSIBLE to modernize the Food and Drug Administration without mangling its effectiveness? Sen. Barbara Mikulski is among those who believe it is, and she is co-sponsoring legislation that would implement a number of reforms.
But some consumer groups see some of these proposals as little more than a sell-out to industries that have contributed heavily to congressional campaigns and now want their reward. They are waging a pitched battle to defeat the bill, or at least key parts of it.
Among other things, these groups charge that no hearings were held on the current bill, although information-gathering hearings were held on the general topic of FDA reform. But their criticisms have made an impact on the negotiations on the bill, which are still in progress.
Most everyone acknowledges that the tough standards on new medicines and medical products constitute the world's "gold standard" of such regulation. Here and around the world, FDA approval carries a cachet that is reassuring to consumers and valuable to industry. Clearly, the challenge in carrying out any reforms of FDA is to modernize the agency without diluting its authority.
One provision of the legislation gets agreement all around: reauthorization of the Prescription Drug User Fee Act, a 1992 law that has generated enough fees to cut the average time needed to approve new drugs almost in half. Now, the biotechnology and medical device industries are looking for flexibility and streamlined procedures that will afford them similar benefits.
Already, the agency is conducting pilot projects on some of the proposals included in the bill. Is it too soon to expand them? Senator Mikulski and other supporters of the bill believe not. They say the measure provides adequate protection to consumers and that it does not weaken the FDA's authority.
Obviously, the stakes are high. In states like Maryland, where budding biotechnology companies can live or die by FDA decisions or delays, the bill could have a substantial economic impact. But everybody has a stake in the FDA's rigorous standards and reviews and the protection this affords consumers. Fortunately, this year's debate is being conducted without the degreeof mindless anti-regulatory rhetoric that characterized previous attempts of reform. That in itself is an encouraging step.
Pub Date: 7/16/97
