Why the FDA needs to step up

  • Share
  • Read Later

Obama’s commissioner for the Food and Drug Administration says her agency must act faster and be more aggressive about enforcing food and drug safety laws. “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick and the FDA must be visible,” Margaret Hamburg said in an address yesterday.

Is U.S. product safety really such a big problem? It can be. The FDA protects against dirty foods and faulty medical devices, drugs, and cosmetics. But a series of recent embarrassments suggest that the agency should indeed step up its efforts. Last summer a House panel lambasted the FDA after dozens died from contaminated doses of the blood thinner heparin. It seems the product came from a Chinese plant that the FDA had neglected to inspect. And there have been two serious blunders over food since early 2008: Last year the agency warned against tomatoes, only to find out that a major salmonella outbreak was actually caused by peppers; in January, salmonella led to a massive recall of peanut butter, but the FDA was criticized for not pinpointing the source quickly enough.

Of course, any agency with as much responsibility as the FDA is bound to hit road bumps once in a while. But there’s a sense here that the FDA has been too lax in the recent years. The Associated Press reports:

Last year, for instance, the agency issued 22 letters to drug companies for improper advertisements, down from 157 letters in 1998. A Government Accountability Office report found that in the time it takes the FDA to send a warning letter after a problem has been detected — an average of four months — the advertisement at issue is often no longer even in use.

So heightened vigilance is probably a good idea. In her public address, Hamburg promised new and clearer deadlines for company compliance once an FDA inspection finds a problem, and said that the agency would now be willing to shut down a company’s production without warning, if people’s health were at risk.

0 comments
Sort: Newest | Oldest