I Will Believe it When I See It.
August 7, 2009
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.”
The new FDA — the one Hamburg took the helm of just eight weeks ago — will be much more aggressive and visible. “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” she said.
Specifically, she 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.”
By beefing up its enforcement efforts, Hamburg said the FDA will ensure that “violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”
Since Hamburg took the helm of the FDA, the agency has been aggressive in cracking down on the makers of misleading or potentially dangerous products.
For instance, the FDA recently issued 65 warning letters to Web sites hawking phony products that supposedly prevent, diagnose, or treat the H1N1 (swine flu) virus — including a “virus killing” shampoo. According to Hamburg, 80% of the Web sites contacted by the FDA have removed the products.
Where 10 such products were popping up every day, the FDA is now aware of about two new ones a week.
Also, the FDA last week sent warning letters to companies that sell dietary supplements containing anabolic steroids, and posted a public health advisory warning consumers to avoid body-building supplements that contain androgen, estrogen, and progestin-related ingredients.