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How drug-approval woes crept up on FDA

Critics charge conflict of interest in a system where pharmaceutical giants fund the regulatory process.

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For many Americans, opening up the medicine cabinet may seem far more perilous than it did just a few months ago.

Revelations about potentially deadly problems with government-approved drugs - from Merck's painkiller Vioxx to Bayer's cholesterol-fighter Baycol - have prompted even the conservative Journal of the American Medical Association (JAMA) to charge that the Food and Drug Administration's system for protecting consumers is broken.

The JAMA's doctors are calling for an independent board to be set up to monitor the safety of drugs already on the market.

The pharmaceutical industry calls that "premature," noting that FDA has asked the prestigious Institute of Medicine to study the problem and then make recommendations. But consumer advocates and some members of Congress contend that change is long overdue, in part because of the FDA's financial dependence on the pharmaceutical industry. That, they say, creates a conflict of interest that undermines the agency's effectiveness.

"The FDA has a relationship with drug companies that is far to cozy," says Sen. Charles Grassley (R ) of Iowa, who chaired hearings last week on drug safety. "That's exactly the opposite of what it should be. The health and safety of the public must be FDA's first and only concern."

This growing conflict over drug safety illustrates the difficulty the nation has had in achieving the right balance in regulating drugs that, while intended to help save lives, can come with very serious risks.

In the 1980s, critics railed against the FDA for being too slow in approving drugs. One congressman referred to FDA investigators as "pusillanimous and faint-hearted" for their cautious approach.


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