Several known industry critics have surfaced as candidates for the job of FDA Commissioner. The first is Joshua Sharfstein, MD, head of the Baltimore Health Department. Dr. Sharfstein is a former staffer for Rep. Henry Waxman, the California Democrat who recently became chairman of the influential House Energy and Commerce Committee. Dr. Sharfstein is currently leading a transition team charged with assessing the FDA for President-elect Barack Obama, and has visited FDA recently to discuss contentious agency issues. Dr. Sharfstein is known for being critical of past industry marketing practices.  He was also recently involved in the effort to block the sale of over-the-counter cough and cold medicines to young children. Based on his past history, Dr. Sharfstein would likely promote a tougher FDA enforcement environment if he were to become FDA Commissioner. 

The second candidate for FDA Commissioner is Steven Nissen, MD, head of Cardiovascular Medicine, Cleveland Clinic. Over the past few years, Dr. Nissen has publicly questioned the safety of the popular diabetes and anticholesterol medications, Avandia and Vytorin.  Further, Dr. Nissen recently stated that FDA should require drug companies to prove their drugs save lives rather than merely achieve a presumed therapeutic benefit. He has also criticized FDA for permitting use of the “accelerated approval” pathway to drugs not warranting such consideration. Dr. Nissen has criticized industry for, in certain cases, delaying public disclosures of potential product dangers due to concerns about the release of trade secret/proprietary information.

Another name being floated for FDA Commissioner is Janet Woodcock, MD, the current director of the Center for Drug Evaluation and Research. However, Dr. Woodcock, as a long-time senior FDA official, is viewed as less likely to carry out comprehensive FDA reform versus someone from outside the agency. Thus, if Dr. Woodcock were appointed, it would likely be to serve as interim Commissioner until a permanent replacement can be found and/or vetted.

In summary, it is clear by the names being floated for FDA Commissioner that the Obama Administration is committed to an agenda of significant FDA reform. 

Please let us know if you have any questions.

Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939

James R. Ravitz
ravitz.james@arentfox.com
202.857.8903

James H. Hartten
hartten.james@arenfox.com
202.857.8983