Press reports say that President Barack Obama intends to nominate Margaret A. Hamburg, a former New York City health commissioner, to lead Food and Drug Administration, according to the New York Times, Wall Street Journal, and Time. Joshua Sharfstein, the health commissioner of Baltimore, is expected to be chosen as deputy director. What do these choices mean for the pharmaceutical industry?

Observers say that Hamburg is largely well respected as a public health safety expert and is seen as a middle-ground choice between the pharmaceutical industry and consumer groups in the debate on whom should lead FDA.

Hamburg, a physician, was appointed by New York City (NYC) Mayor and Democrat David Dinkins as acting health commissioner in 1991, a position she retained in the next administration of Republican Ruldoph Giuliani. She left in 1997 to become assistant secretary for planning and evaluation at the US Department of Health and Human Services under the Clinton administration. She currently is a senior scientist at Nuclear Threat Initiative (NTI), a think tank formed by former Senator Sam Nunn and Ted Turner among others, and formerly served as vice-president for NTI’s biological program. As NYC health commissioner, she developed a tuberculosis-control program and increased child-immunization rates, and at HHS, she created a bioterrorism initiative and led planning for pandemic flu response, according to the New York Times article.

One interesting theory offered by some is that the possible nominations of Hamburg and Sharfstein may indicate potential organizational change at the agency. Peter J. Pitts, a former FDA associate commissioner and president and cofounder of the Center for Medicine in the Public Interest (CMPI), a nonprofit health-care policy firm, postulated in the New York Times article and on a CMPI blog that the move toward selecting Hamburg and Sharfstein may indicate an interest on the part of the Obama administration to divide the functions of FDA, with Hamburg using her health-safety expertise to become commissioner of food and Sharfstein leading a federal drug administration.

Sharfstein was reportedly considered for the top post at FDA by the administration, but was not a favored choice by industry, according to an article in the Wall Street Journal. In addition to serving as health commissioner for the city of Baltimore, he was a former staffer for Rep. Henry Waxman (D-CA), the 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, and a bill on the matter has been introduced into this Congress. Waxman is also involved in proposed legislation that would create a regulatory pathway for follow-on biologics.

If Hamburg does indeed get the nod to lead FDA, she will be faced with the large task of restoring what is perceived as reduced public confidence in the agency. 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. The next FDA commissioner will not only have to restore public confidence but also navigate ongoing pressures in resource allocation and funding in meeting the mission of the agency.