New Leadership at the FDA

The discussion of healthcare reform in the 2008 election was front and center.  Now that the election is over, President-elect Obama is charged with the task of filling a whole host of positions in his cabinet and at various agencies in Washington.

In this post, we discuss the names of several candidates for the position of Commissioner of the Food and Drug Administration (FDA), as it will have immediate and salient effects throughout the life sciences industry.

The FDA Commish oversees a budget of over $2 billion and an employee base of 11,000 (growingly disgruntled) people.  The current head of the FDA, Andrew von Eschenbach, has been heavily criticized, and the driving force in this appointment will likely be a response to these criticisms – safety of approved drugs and integrity of imported food and drugs.

Below is a list of names that have been floated in the past week or so:

David Blumenthal (Harvard University): In addition to his faculty position at Harvard, Dr. Blumenthal is also Director of the Massachusetts General Hospital’s Institute for Health Policy.  His experience in government extends back to his work as a staff member to Senator Edward Kennedy several decades ago.  As a pick for the FDA top spot, Blumenthal is a pretty safe bet.

Steven Nissen (Cardiologist, Cleveland Clinic): Dr. Nissen’s major issue is drug safety.  He played a key role in the Avandia case and has ruffled some feathers in industry due to his perceived antagonism towards approval policies.  Nissen has been an influential voice in shaping President-elect Obama’s health care policy and appears well-positioned for appointment.

Susan Wood (George Washington University): Major supporter of Hillary Clinton.  Former Director of the Office of Women’s Health at the FDA but resigned in August of 2005 amidst dissatisfaction of the way the FDA handled the review of the contraceptive, Plan B.  Dr. Wood was a major supporter of Senator Hillary Clinton’s 2008 Presidential campaign.  Her selection would send a clear statement to the FDA that reform is on the way.

Janet Woodcock (Center for Drug Evaluation and Research at the FDA): Dr. Woodcock is an insider at the FDA and has been seen as the appointee of choice from an industry perspective.  Even when she was appointed to her current position at the FDA, critics questioned that the decision represented “business as usual” at the FDA.  

The list of potential candidates extends beyond these four names, but the consensus seems to suggest that a shake-up at the FDA is likely to occur.  How seamlessly this new leadership will fit with the overarching call for heathcare reform remains to be seen.  But, it is clear that the FDA is presently struggling.