New FDA Commish Brandishes Big Stick, Offers Carrot

By Douglas B. Farquhar –

In an August 6, 2009 speech at an event sponsored by the Food and Drug Law Institute, Margaret A. Hamburg, M.D., the new FDA Commissioner, promised to ratchet up enforcement by speeding up issuance of Warning Letters, reducing the amount of time that industry has to respond to notices of violations, and landing on repeat violators quickly and severely.  However, she also offered a reward to cited companies who respond expeditiously and effectively, in FDA’s view.  She promised that companies which fully correct violations cited in a Warning Letter will receive a “close-out notice,” which will be posted on the FDA website, documenting that the companies have achieved a state of compliance (trumpets sound and choirs sing).  (A copy of FDA's press release announcing Dr. Hamburg's speech and enforcement vision is available here.) 

Warning Letters have traditionally been FDA’s most potent weapon against FDA-regulated industry, short of the agency seeking an injunction, initiating criminal prosecutions, or persuading state officials to shut down a company.  Hundreds of Warning Letters, which are publicly available, are issued every year to food processors, drug manufacturers or distributors, investigators in clinical trials, medical device manufacturers, pharmacies, and Institutional Review Boards (IRBs) which monitor clinical trials.  The agency routinely follows up on Warning Letters with inspections to ensure that corrective actions have been taken.  Enforcement officials at FDA have repeatedly said that if violative conditions cited in Warning Letters are not corrected, the agency will proceed to more significant enforcement measures, including those listed above, or, if available, import detentions.

Noting a “steep decline in the FDA’s enforcement activity over the past several years,” Dr. Hamburg said that many enforcement actions have been “hampered by unreasonable delays.”  She focused primarily on the issuance and resolution of Warning Letters.  Although companies routinely have, by agreement with FDA officials, 30 to 60 days to respond to inspectional reports (Form 483s) citing violations of FDA regulations, she said that, from now on, cited companies will “generally have no more than fifteen working days in which to respond,” thus speeding up the issuance of Warning Letters when responses do not satisfy FDA’s concerns.  Her speech re-emphasized past pronouncements that there will not be “multiple warning letters to noncompliant firms before taking enforcement action.”

She also said that FDA will work more closely with “local, state and international officials” who have authority to shut down companies more quickly than FDA, especially when the “public health is at risk.”

Warning Letters are very rarely retracted or withdrawn by FDA, and there is generally no public indication that a firm has corrected the violations covered by a Warning Letter.  Dr. Hamburg pledged to set up a “close-out” process so that, after a re-inspection determines that “a firm has fully corrected the violations,” the firm and the public will be informed that issues raised in a Warning Letter have been resolved.

Dr. Hamburg praised the agency for its rapid and repeated Warning Letters issued to promoters of products who promised to “diagnose, prevent, or treat” the H1N1 virus (commonly referred to as the “swine flu” virus).  She also praised the agency for its action to stop the distribution of anabolic steroids “sold under the guise of dietary supplements.”