FDA approach tough pill for critics

Houston Chronicle Back in the 1990s, after decades of taking a slow, skeptical approach to approving new medicines, the Food and Drug Administration responded to pressures from patient-advocacy groups, private industry and Congress by streamlining the way it did its job.

Instead of acting as a suspicious cop, the FDA began to embrace a philosophy of working with the pharmaceutical industry as a trusted partner.

It is that sea-change, critics say, that has led to the controversy over Vioxx and to charges that in recent years the agency has too often allowed unsafe drugs to reach the market ? with sometimes catastrophic results.

Even critics concede that the FDA's task is daunting: If it moves too slowly, as AIDS activists and others charged it did in an earlier era, patients may suffer or die. Move too quickly, and patients may be exposed to unrecognized risks.

"I think they're trying to do the right thing. They want to make sure that the public receives drugs that are as safe and effective as possible," said Steven Chen, an assistant professor at the University of Southern California School of Pharmacy.

... "When you have a situation where the industry you are regulating is paying the bills for your regulatory activities, it changes the sense of who you're accountable to, and who's paying your salary," said Jerome Avorn, professor of medicine at Harvard Medical School and author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.

... AIDS patients were not the only Americans who yearned for faster help, however. Accounts of Americans traveling to foreign countries for medication became folklore. Those stories intensified pressure on the FDA to streamline its tradition-bound bureaucracy. The agency responded by creating a fast-track system for assessing so-called breakthrough drugs, stripping months off the traditional process for approval. AIDS drugs were among the first beneficiaries of the new system.

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