As the pieces of President-Elect Barack Obama’s administration fall into place, one looming choice of great importance to the pharmaceutical and biotechnology industries is the choice of the next commissioner of the US Food and Drug Administration. A recent article in the Wall Street Journal (WSJ) put forth speculation on possible candidates for the top post.
One name being bandied about is Joshua Sharfstein, commissioner of health for the city of Baltimore, who WSJ reports is a former staffer for Rep. Henry Waxman (D-CA), the incoming chairman of the House Energy and Commerce Committee. The House Energy and Commerce Committee is the committee that held Congressional hearings in 2008 on the discussion draft of the Food and Drug Administration Globalization Act of 2008, which seeks improvements for FDA’s inspection process for drug-manufacturing facilities. In November, John Dingell (D-MI), current chair of the committee, and other committee members, who have been critical of FDA’s inspection and related efforts, pledged to move forward with proposed legislation in the next Congress.
Another name under consideration, according to the WSJ article, is Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. Nissen served as a member of FDA’s CardioRenal Advisory Panel for five years and as chairman of the final year of his membership. He continues to serve as a periodic advisor to several FDA committees as a Special Government Employee. Also, WSJ reports that industry members are placing the name of Janet Woodcock, now director of the Center for Drug Evaluation and Research at FDA, in the hopper.
For these possible candidates or others, one thing is for sure, he or she will need to be prepared for the significant policy and operational issues at hand at FDA. Over the last several years, FDA has faced ongoing criticism concerning its ability to effectuate drug-product safety, either through its clinical evaluations in the drug-approval process, such as in the high-profile case of “Vioxx” (rofecoxib), or adequately regulating manufacturers and the inspection of their facilities, particularly offshore manufacturers, as in the case of contaminated heparin.
For the next leader at FDA, one solution for these problems, most notably additional funding for staffing, training, and other operational support such as in information technology, is in short supply given mounting fiscal uncertainty on the federal level.
Although balancing resources to solve problems while ensuring product safety is the task for any FDA commissioner, the next FDA head will more than ever have his or her hands full beginning January 20, 2009.
See the results of PharmTech’s reader poll about the new FDA commissioner here.