Clinton OKs Measure to Revamp FDA

President Clinton signed legislation on Friday aimed at streamlining the way the Food and Drug Administration reviews and approves new drugs and medical devices, an effort that seeks to preserve public safety while getting these products to consumers faster.

“This legislation is very, very important,” Clinton said. “When we have new possibilities in both medicine and medical devices, . . . what we want to do is get those to people as quickly as possible and still protect the public interest.”

The law establishes a program to try to accelerate the review system for experimental medical devices. It also makes it easier for desperately ill patients to get experimental drugs outside of clinical trials.

It also renews the popular Prescription Drug User-Fee Act, a program that already has speeded up the drug review process.

The FDA has long struggled to achieve a balance between the need to approve new products expeditiously while ensuring that the public is not harmed by them.

Momentum to change the FDA was fueled by the Republican takeover of Congress in 1994, when GOP leaders accused several public health and safety agencies, including the FDA, of “over-regulation.”

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Attempts then to “reform” the FDA failed on Capitol Hill, in part because many lawmakers believed that the changes would weaken the agency, making Americans vulnerable to inadequately tested products.

Indeed, Clinton noted that “at the beginning of the process, the sides stood worlds apart. I think that is an understatement.”

Several activist groups continued to blast the measure Friday as “bad for public health,” claiming that it still weakens the FDA.

But the agency said the end result--a series of negotiated compromises that maintained FDA oversight over the most significant changes--”preserves our basic standards, which is what we fought for.”

In fact, many longtime FDA watchers said privately that the legislation codifies much of what the agency already has been doing in recent years and predicted that the ultimate practical effect on consumers will be slight.

For example, the new law expands a current pilot program to allow most experimental medical devices to be reviewed by outside experts chosen and paid for by the manufacturer.

The agency already had been looking into widening the program, but few companies have chosen to use it. Only about a half-dozen devices have gone through review by outside parties. Some agency officials speculated that interest in outside review has dwindled as the agency has improved its own device-review performance.

The new law expands the program but maintains FDA oversight by requiring the agency to certify outside reviewers in advance and make the final decision on the device.

Also, outside reviewers will not be permitted to review the riskiest devices, such as heart valves and other implantable items.

The changes also will allow drug companies to circulate among physicians the results of studies of “off-label” uses of licensed drugs, provided manufacturers agree to study them in larger numbers of patients and seek formal approval for those uses from the FDA.

The law also will allow terminally ill patients greater access to experimental drugs that are under study, even if the patients are not part of formal clinical trials of that drug or do not qualify for the studies. Currently, AIDS and cancer patients have such access. The provision would expand the concept to other life-threatening or debilitating ailments.

Under the measure, food companies will be permitted to add health claims to their food labels if the claims have been substantiated by a federal scientific body, such as the National Cancer Institute. The FDA would have 30 days to review the claim and--if it disagrees--can block or postpone it.

Currently, such claims are allowed but must first go through a more lengthy FDA rule-making procedure.

John R. Cady, president of the National Food Processors Assn., called the legislation “a win for consumers and for the food industry” that “enhances the right of consumers to receive more information about the health benefits of foods.”

But the Center for Science in the Public Interest said the law would “make it more difficult for the FDA to halt misleading claims” on foods.