FDA Commissioner Hones Enforcement

Commissioner of Food and Drugs Margaret Hamburg, M.D., today outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations.

“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” Commissioner Hamburg told a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington, D.C.

Hamburg said that some FDA enforcement actions over the past several years “have been hampered by unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long.” She added that the pathways for enforcement actions “can be too long and arduous when the public’s health is in jeopardy.”

Commissioner Hamburg highlighted six initial steps designed to hone the effectiveness and timeliness of the FDA’s regulatory and enforcement system:

  • Set post-inspection deadlines.
  • Take responsible steps to speed the warning letter process.
  • Work more closely with FDA’s regulatory partners.
  • Prioritize follow-up on warning letters and other enforcement actions.
  • Be prepared to take immediate action in response to public health risks.
  • Develop and implement a formal warning letter “close-out” process.”
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One response to “FDA Commissioner Hones Enforcement

  1. Carl's Blog on FDA Stuff

    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 Many regulations are outdated.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/

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