The appointments signal significant challenges ahead; FDA compliance and enforcement actions are likely to increase substantially.

In his weekly radio address on March 14, 2009, President Barack Obama announced the appointment of Dr. Margaret “Peggy” Hamburg as commissioner-designate of the U.S. Food and Drug Administration (FDA), and of Dr. Joshua Sharfstein as principal deputy commissioner. Click here for more information. Dr. Hamburg’s appointment requires Senate confirmation; Dr. Sharfstein’s does not. These appointments were announced at the same time as President Obama announced the creation of a Cabinet-level interagency Food Safety Working Group intended to report back to him as soon as possible about ways to strengthen the nation’s food safety system, whose weaknesses have been exposed so glaringly in the recent salmonella-contaminated peanut butter debacle and other incidents.

While President Obama focused on food safety in announcing the Hamburg and Sharfstein appointments, the problems confronting the incoming FDA commissioner and principal deputy commissioner range much more broadly. Perhaps most notably, these problems include an agency whose stature, credibility and morale have been seriously eroded as a consequence of a seemingly endless parade of perceived missteps. These range from drug safety concerns, typified most notably by the public health issues surrounding drugs such as Vioxx, to the current controversy about the integrity and independence of the entire medical device clearance and approval regime occasioned by anonymous complaints from concerned scientists in FDA’s Center for Medical Devices and Radiological Health. Add to this the incessant congressional oversight that all of this has occasioned, and one can readily see why the new team at FDA has its work cut out for it.

Dr. Hamburg and Dr. Sharfstein each bring impressive credentials to their respective appointments. These were highlighted by President Obama in his radio address, and the press release accompanying the transcript of the President’s remarks provides additional biographical details about each of them. Click here for more information. At the same time, one can reasonably ask whether the array of challenges facing FDA at this precarious moment in its more-than-100-year history are manageable by even these talented individuals. For example, Congress seems poised to give FDA jurisdiction over tobacco product. This will take an agency whose long-standing mission is to protect the public health into regulation of products that most people believe are fundamentally at odds with the public health. Whether this will ultimately erode FDA’s core public health mission is anyone’s guess. But it will divert significant time and attention from areas, such as food safety, that President Obama himself acknowledges require fixing.

Likewise, Congress is now considering legislation that would establish a pathway for the review and approval of follow-on versions of pioneer biologicals approved by FDA under the Public Health Service Act. This legislation has been identified as one centerpiece of the administration’s overall health reform initiative. If enacted, as seems likely, follow-on biologics (FOB) legislation would require significant time and attention from senior FDA management to implement properly. It is speculated that Dr. Sharfstein would have primary responsibility over drugs and biologicals, whereas Dr. Hamburg would focus her attention to food safety and other high priority issues. Despite this division of responsibility, it seems apparent that, if confirmed, the new FDA commissioner will have to devote considerable personal time to implementation of an FOB regime and could not delegate all of this responsibility to the principal deputy commissioner without in some sense abdicating part of the mandate that would accompany her confirmation by the Senate. Moreover, FDA has significant unfinished business to attend to in its overall implementation of the Food and Drug Administration Act of 2007, particularly in connection with its authority to require Risk Evaluation and Mitigation Strategies (REMS). The scope of this new authority will be seriously tested in, among other contexts, FDA’s recently announced call for a REMS for approved and already-marketed long acting opioid drugs that have significant potential for abuse. Indeed, FDA has already threatened to withdraw approval for these drugs unless the manufacturers themselves agree to develop and implement a single overarching REMS that would apply to all of them. Other significant challenges, such as the unwinding of the Bush administration’s position on federal preemption of state law failure to warn lawsuits involving prescription drugs, in response to the Supreme Court of the United States’ recent decision in the Levine case, will similarly require attention. In addition, FDA will need to address whether and to what extent it will regulate laboratory developed tests under its “medical device” authority. In turn, this will have significant implications for FDA’s entire approach to “personalized medicine.”

Perhaps most significantly for the regulated community, one can expect to see a substantial uptick in compliance and enforcement activity from a newly constituted Obama FDA led by Commissioner Hamburg and Principal Deputy Commissioner Sharfstein. Indeed, we have already seen an increase in enforcement in FDA’s regulation of pharmaceutical and biotech advertising and promotion in anticipation of the impending management changes. Other areas that are likely to be the focus of substantially enhanced compliance and enforcement action by FDA include bioresearch monitoring, good manufacturing practices, medical device modifications without prior FDA clearance or approval, and off-label promotion of both pharmaceuticals/biologicals and medical devices, among others. In this context, it seems important for FDA-regulated entities to take stock of where they stand on significant regulatory and legal issues of concern. McDermott Will & Emery can provide significant insight and assistance to clients in addressing FDA issues they are facing or likely to encounter going forward.