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FDA Clamping Down For Safety

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Industry insiders are noting a recent trend of the Food and Drug Administration (FDA) flexing its regulatory muscles. This uptick in regulatory action is assumed to be a reaction by the Obama administration to a gridlocked Congress’s inaction on consumer safety legislation, most notably the Senate’s failure to act on a House-passed food safety bill despite the recent salmonella outbreak that affected over 1,500 people and prompted the recall of more than half a billion eggs. Notable recent FDA actions include issuing warning letters to several companies for misleading advertising and labeling, issuing a warning about the potentially deadly risks associated with certain products aimed at preventing Sudden Infant Death Syndrome (SIDS), and announcing that Meridia, and anti-obesity drug manufactured by Abbott Labs.

Increased FDA regulatory action typically coincides with a surge in consumer protection and tort lawsuits, though it is often hard to tell which one was the catalyst and which was the response. In response to the increase in activity, industry groups are focusing more attention on lobbying against the FDA’s actions, and will likely challenge many of the FDA’s new rules in court.

Without FDA oversight of these areas, however, there are few checks on corporations who take short-cuts for profit over safety. One of the few effective checks and balances is the tort system, which allows those injured to seek redress through the court system. Many well-financed forces oppose both the FDA (and government oversight in general), as well as the tort system – because these forces effectively want immunity for their actions. They, however, will argue strongly to protect their own day in court, just not the little guy’s day.