F.D.A. commissioner details public health commitment

by Eric Schroeder
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WASHINGTON — Margaret A. Hamburg, commissioner of the Food and Drug Administration, today outlined her vision for cracking down on food and drug companies that break the law as part of a larger effort to support public health.

Ms. Hamburg said an effective enforcement strategy depends on several key elements, including the F.D.A.’s need to be vigilant, strategic, quick and visible.

"In recent years, the Government Accountability Office and others have suggested that the F.D.A.’s enforcement efforts may not have always lived up to these principles," Ms. Hamburg said. "Reports have noted that there has been a steep decline in the F.D.A.’s enforcement activity over the past several years. At the same time, many of the enforcement actions that the F.D.A. has undertaken have been hampered by unreasonable delays.

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

Ms. Hamburg outlined several initial steps the F.D.A. plans to take to improve the effectiveness of the nation’s enforcement system.

First, the F.D.A. will set post-inspection deadlines. Doing so, Ms. Hamburg said, will force companies that are out of compliance to quickly respond with action or risk being faced with a warning letter or enforcement action.

Second, the F.D.A. will take steps to speed up the issuance of warning letters. To this end, Ms. Hamburg said she has approved a new policy that will allow most enforcement letters to move forward through a more streamlined process.

Third, the F.D.A. will work more closely with regulatory partners to develop effective risk control and enforcement strategies. In implementing this step, the F.D.A. now should be able to more quickly act when public health is at risk, Ms. Hamburg said.

A fourth step being taken allows the F.D.A. to prioritize enforcement follow-up. This step will allow the F.D.A. to promptly follow up with appropriate action after a warning letter is issued or a major product recall occurs.

Fifth, the F.D.A. will be prepared to act "swiftly and aggressively to protect the public." Ms. Hamburg said the F.D.A. will no longer issue multiple warning letters to non-compliant companies before taking action and will consider immediate action even before issuing a formal warning letter.

"These five procedural changes will help to 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," she said.

Ms. Hamburg also said the F.D.A. is developing a formal warning letter "close-out" process that will allow the F.D.A. to indicate on its web site when a company successfully has corrected any violations raised in a warning letter. While not every type of warning letter will be eligible for a "close-out" letter, Ms. Hamburg said she hopes it may play an important motivating role in spurring corrective action.

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