A Look Back at the FDA in 2008

David Mittleman

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The federal Food and Drug Administration (FDA) has taken a bit of a beating this year. A number of drugs approved by that agency have turned out to be dangerous, and tainted food products kept popping up on store shelves. It turns out the FDA is facing criticism from both sides: Drug companies want more drugs approved, while consumers want the agency to help keep them safe from dangerous drugs and other products. These two goals are generally not compatible - if the FDA rushes a drug to the market, there is a greater chance that it could end up being unsafe. Something has to give.

Given the FDA’s recent track record, it seems like the agency should take a step back and try to return to its original mission: protecting consumers. Several FDA-approved drugs have been tied to significant injuries this year, including heparin, Trasylol, digoxin, Avandia, Singulair, and others. The agency has also had to answer some tough questions about the safety of chemicals such as BPA and explain how melamine-tainted products made it into the US.

Despite these numerous shortcomings, the FDA continues to protect pharmaceutical companies. Injured consumers are often left with little or no recourse, because in several states drug companies enjoy immunity from suit if their drugs have been approved by the FDA. This immunity could be extended nation-wide, depending on the outcome of a key case currently before the US Supreme Court.

The Food and Drug Administration had a rough year in 2008. Perhaps it should take a cue from the many Americans who make New Year’s resolutions in the hopes of bettering themselves during the coming year.