Drugmakers: Prepare for a Smackdown

The FDA plans to lay heavier regulations on Big Pharma.

By Linda Marsa|Friday, June 20, 2008

For years the Food and Drug Administration has failed to adequately monitor the pharmaceutical industry. That conclusion by a special committee at the Institute of Medicine in a September 2006 report titled “The Future of Drug Safety” helped prompt a sweeping reform bill that became law last September. The Food and Drug Administration Amendments Act of 2007 gives the FDA the dollars and legal clout it needs to make a number of important fixes. Its key provisions and other new initiatives include these:

• The FDA will hire 1,300 new employees, with at least 400 dedicated to drug review.

• The agency has earmarked money for the development of a network of organizations to monitor the safety of FDA-approved drugs. Assembled and led by the FDA, the network participants—which include health-care insurers and providers—will have the ability to search millions of their own database records at the agency’s request. This surveillance system is built to identify problems, such as side effects of pharmaceuticals and medical therapies, as they emerge.

• All clinical trials of every FDA-approved drug must be registered on an NIH Web site, with results of those trials also posted.

• The FDA can now compel companies to do more studies as warranted even after drugs are approved.

• Penalties of up to $10 million may be imposed for violations of the new REMS (risk evaluation and mitigation strategy) provisions, designed to manage a known or potential serious risk associated with a drug or biological product.

• The agency can now demand more rapid changes to drug warning labels if new side effects emerge.

• Print drug ads now need to have a hotline number consumers can call to report bad reactions. TV commercials must present side-effect warnings in a “clear, conspicuous, and neutral manner”—a mandate the agency is currently defining.

While these are positive steps, it may be years before they are fully implemented, and many people question just how great their impact will be. “Having the authority and using it wisely are two different things,” says the chairman of the Cleveland Clinic’s department of cardiovascular medicine, Steven Nissen, who advised Congress on the FDA overhaul. “We’ll just have to wait and see how well the FDA uses its new powers.”

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