Medical Device Daily Washington Editor

WASHINGTON – Margaret Hamburg, MD, the latest FDA commissioner, was not hired to do business the same way as her immediate predecessor, and the unambiguous message from her address yesterday to the Food and Drug Law Institute (Washington) was that with her at the helm, FDA will more strongly resemble the FDA of David Kessler than that of Andrew von Eschenbach. The first thing she said in her presentation made the new focus of FDA clear; that she was there to discuss enforcement.

Hamburg's appearance coincided with an announcement at the agency's web site detailing some of the steps it will take in ramping up enforcement. The agency's Aug. 6 announcement appeared around the time Hamburg made her remarks to the audience, presenting an outline of her discussion at the FDLI event.

One of the more interesting remarks Hamburg made was that she would like FDA to be in a better position to act unilaterally when dealing with products the agency perceives to be a threat to public health. "It is the case that FDA's arms are tied in ways that we'd like to liberate just a bit," she said in a portion of her talks dealing with tainted foods. While Hamburg did not explicitly state that the idea applies also to drugs and devices, she commented that when the agency comes upon information that a faulty product presents "a pressing public health concern," she would like the agency to be able to avail itself of "the ability to access certain kinds of records," and conduct "a more thorough trace-back" of a product to its origin than FDA is currently statutorily empowered to conduct.

On the subject of warning letters, Hamburg's remarks harkened back to the time when warning letters were not routinely routed through the agency's Office of General Counsel (GC). "I have approved a new policy . . . to limit warning letter review to significant legal issues," allowing warnings "to go through a streamlined process" unless legal review is indicated, she said. The move reverses a policy applied in the first year of the administration of President George W. Bush, which led to a substantial drop in the numbers of warning letters.

Hamburg said that the GC review created "a cumbersome process without a lot of demonstrated benefit," adding that the reversal was not motivated by partisan politics, as one questioner's query hinted. She said the move was driven by the perception that the procedure "is not a good use of people's time," and that GC's time will be better applied to warning letters when it is "appropriate and necessary" in order to address "a complex legal issue."

As has been widely expected since the election of then-Senator Barack Obama to the presidency, inspections will become more frequent. However, Hamburg indicated that companies that stumble into a warning letter will now be able to win a seal of approval from the agency upon successful completion of corrections. She described a "formal warning letter close-out process" whereby if a firm has fully corrected violations, "we will provide a close-out letter" stating that the issues have been addressed.

"Not every type of warning letter will be eligible for a close-out letter," Hamburg said without offering specifics, but added, "I hope receiving a close-out letter becomes a top industry priority." The purpose of the close-out process is "to communicate to the public that the problems have been corrected," Hamburg said, adding that the entire process is part of the agency's transparency effort that will reassure the public that FDA is on the job. "Ultimately, an effective enforcement strategy creates public confidence" and encourages industry to comply, she said.

Hamburg reported that among the changes contemplated is that when an FDA investigator issues a 483, "we expect a prompt response to our findings," noting that the expectation is now that companies will respond within 15 days. Fifteen days is also the stated deadline for responding to a warning letter, but device makers often do not respond within 15 days in either case.

"The agency must place greater emphasis on significant risks of violations," and "must be able to respond rapidly to egregious violations," Hamburg remarked. The agency will also "prioritize enforcement follow-up," she said, and "will do more follow-up inspections."

Hamburg warned industry that FDA "will be prepared to act swiftly and aggressively to protect the public" from products deemed a threat to public health and that FDA will tolerate no more multiple warnings. "We will consider immediate action before we issue a warning letter" in the case of companies with a rocky compliance history, she said. n

Mark McCarty, 703-268-5690,