Newer Tougher FDA?

margaret-hamburg In the past the FDA has stood as a protector of the american people although sometimes slow to act and often without the full enforcement power of some other government branches.

This may soon change.

The new chair of the FDA Margaret Hamburg has spoken out lately and probably with the Obama administration has been given a bit more rein and ear to the Oval Office than her predecessors have had.

FDA Commissioner Margaret Hamburg, MD, vowed that the agency would be more aggressive in enforcing food and drug safety regulations and quicker to act when a company breaks the law.

In a speech at the Food and Drug Law Institute, Hamburg said that some FDA enforcement actions over the past several years have been “hampered by unreasonable delays” and that there has been a “steep decline in enforcement.”

“In some cases, serious violations have gone unaddressed for far too long,” Hamburg said. “These include violations involving product quality, adulteration, and misbranding, false, misleading, or otherwise unlawful labeling, and misleading advertising.”

Only eight weeks on the job as commissioner and speaking as strongly as she is, I am hoping that the FDA will do even better than it has in the past.

Margaret Hamburg also said the agency will do the following:

Create a clear timetable for companies to respond to FDA inspection findings, generally no more than 15 days after the inspection. If the company fails to respond, the agency will issue a warning letter or take other enforcement action.
Streamline the warning letter process by limiting legal review of letters to those that might actually present major legal issues, and prioritize the follow-up process on warning letters.
Rely more on local, state, and international officials in food safety situations that require quick action.
Be prepared to act “swiftly and aggressively” when dealing with significant public health concerns, possibly even before a formal warning letter is issued. The agency will no longer issue multiple warning letters before dealing with a violation, Hamburg said.
If a company has corrected whatever issues were raised in a warning letter, the FDA will publicly clear the company on its Web site. Hamburg called it a “close out process.”

Time will tell. It will be interesting to watch.

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