Jill Wechsler

FDA's new leadership wants to turn that around. Principal Deputy Commissioner Joshua Sharfstein, who was FDA's acting commissioner pending confirmation of Margaret Hamburg for the top spot, took highly visible enforcement actions to illustrate that a new sheriff is in town. Soon after coming to FDA at the end of March, Sharfstein initiated a fast and aggressive recall of pistachio products as soon as evidence of salmonella contamination appeared. He also responded to criticism of FDA's process for regulating medical devices by supporting a review of safety information required for device classes.

Science & Swine Flu

Another new face at FDA reflects the agency's newly aggressive regulatory and legislative approach. David Dorsey, former top aide to Sen. Edward Kennedy (D-MA) on the Senate Health, Education, Labor, and Pensions (HELP) Committee, was named senior counsel to Sharfstein. Dorsey was a lead negotiator on legislation authorizing user fees, pediatric studies, and the Food and Drug Administration Amendments Act (FDAAA) of 2007. He also worked closely with Kennedy on proposals for authorizing biosimilars and for regulating dietary supplements.

"Enforcement will increase," warned Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER), at the April annual meeting of the Food and Drug Law Institute (FDLI). She pointed to a rise in injunctions, investigator disqualifications, and Warning Letters and advised companies to avoid the big stick by "being proactive about compliance."

Attorney Jim O'Reilly predicted a visible shift from the "kinder, gentler" approach of the Bush administration to active monitoring of violative operations. Former FDA counsel Bob Spiller complained that "FDA civil enforcement was cuffed and curbed and starved over many years;" now he anticipates big changes with more resources available for enforcement efforts.

One sign of the times is an expansion in Autor's compliance office to 250 staffers from 150 five years ago. The growth increases FDA's ability to take regulatory action. CDER issued almost 40 Warning Letters between Jan. 1 and Apr. 14 of this year, nearly half of the 87 sent out in all of 2008. CDER's Division of Drug Marketing, Advertising, and Communications also sent notice-of-violation letters to 14 drug companies in early April charging that sponsored links on Internet search engines such as Google provide information about drug benefits without fully disclosing risks. Marketers objected that FDA was ignoring the communications capabilities of Internet technology, but consumer advocates supported the move as a way to ensure comparable disclosure of information on risks along with benefits.