FDA Head Promises Stronger Enforcement Of Food/Drug Safety

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Food and drug companies that commit safety violations will face faster and more aggressive action, the new commissioner of the U.S. Food and Drug Administration said Thursday.

"The agency must show industry and consumers that we are on the job," Margaret Hamburg told an audience of food and drug industry lawyers, the Associated Press reported. "Companies must have a realistic expectation that if they are crossing the line, they will be caught."

Hamburg said the FDA's efforts in recent years "have been hampered by unreasonable delays" that left many safety violations unpunished.

Since Hamburg was confirmed as commissioner in May, the agency has launched a number of enforcement actions against companies selling fake or dangerous products, the AP reported. This type of enforcement will become routine in the future, Hamburg said.

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Anonymous

I welcome a tougher stance on enforcement of FDA regulations. I think that Dr. Hamburg is off to a good start. However, I have some concerns that there will be unintended consequences. First, FDA has been going after some relatively easy targets, such as internet fraud for H1N1 "remedies." Next, there needs to be a corresponding improvement on training FDA personnel so they adequately and fairly enforce the regulations. Many regulations are outdated. The clinical trial regulations date back to the 1970s and don't address today's issues.

You may read more of my viewpoints on my blog, Carl's Blog on FDA Stuff, found at: http://carl1anderson.wordpress.com/

August 9, 2009 - 12:37pm