The Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., has just released a statement outlining her commitment to protect the American public "through swift, aggressive, and effective enforcement of FDA laws and regulations," according to a press release on the FDA website.

"The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible," Commissioner Hamburg said in a speech sponsored by the Food and Drug Law Institute in Washington D.C. "We must get the word out that the FDA is on the job."

Commissioner Hamburg also stated that in the past several years enforcement has been hampered by unreasonable delays, and "in some cases, serious violations have gone unaddressed for far too long," and the process for enforcement actions "can be too long and arduous when the public's health is in jeopardy."

In her speech, Commissioner Hamburg highlighted six initial steps to improve 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 enforcement follow-up on warning letters and other actions;
--Be prepared to take immediate action in response to public health risks;
--Develop and implement a formal warning letter "close-out" process.

The Commissioner said the framework she had outlined bears on the broad range of regulated products the FDA oversees. "We want to work as closely and constructively as possible with various partners in industry to make the FDA regulatory process as transparent as possible... to make sure that we have clarity of policy, that we articulate our expectations and standards clearly and that we work in a proactive way to make sure that the systems are in place to prevent problems from arising in the first place. When they do arise, we want to work [with the industry] to fix them.... but if there is a problem that is clearly immediately a threat to the health of the public, that is when we must act swiftly and surely."

The FDA's release quotes Commissioner Hamburg's statement that with these steps, the FDA will ensure that "violative inspection results 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."

Adapted from a press release by the FDA and the videotaped speech of Commissioner Hamburg.

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