Drug industry uneasy with Obama's choice for FDA deputy

Food, pharmaceutical, and medical device groups said they were happy with President Obama’s pick to lead the Food and Drug Administration (FDA), but that his selection for second in command is giving them a heartburn. CongressDaily’s Anna Edney writes that industry insiders describe their colleagues as cautiously optimistic about FDA administrator-nominee Margaret Hamburg, a former New York City health commissioner who works at a nuclear nonproliferation think tank, but nervous in varying degrees about Baltimore City health commissioner Joshua Sharfstein.

“Hamburg will be focused on the food supply and creating regulation of tobacco, and to some degree it’s expected Sharfstein will have a certain amount of autonomy on pharmaceuticals and medical devices,” one lobbyist said. “Companies are clearly going to get more scrutiny.” The drug industry is viewing the dual picks, as one FDA lawyer put it, as a “power-sharing agreement.”

Obama emphasized food safety when he announced the selections of Hamburg and Sharfstein, referring to the string of deadly food-borne illness outbreaks in recent years. Hamburg’s public health and bioterrorism background make food safety a natural fit. She is a senior scientist at the Nuclear Threat Initiative.

Sharfstein, on the other hand, has a long and sometimes contentious history with the pharmaceutical industry. “Anyone who spent their career under Henry Waxman …,” said one lobbyist, trailing off with a shudder. Sharfstein worked under the now-House Energy and Commerce chairman from July 2001 to December 2005, a Waxman spokeswoman said. Waxman, a California Democrat, has been tough on drug companies, particularly given several scandals involving contaminated drugs or unheeded warnings in the recent years. Sharfstein has carried the torch on many of his former boss’s public health priorities, ranging from cracking down on medication use for illnesses not approved by FDA to criticizing pharmaceutical companies for gifts handed out to physicians.

Edney writes that Sharfstein led the Obama transition team’s FDA evaluation and was thought by many to be a shoo-in for the top post at the agency. He raised warning bells as well that led the agency to re-evaluate the safety of cough and cold medicine use for children. The pediatrician could play a key role implementing 2007 FDA legislation that set up a system for pharmaceutical companies to assess risks associated with their products and come up with a plan to mitigate those risks — hence the term risk evaluation and mitigation strategy, or REMS. The law affords FDA the discretion to determine how stringent a product’s REMS should be, and the drug world fears potentially burdensome REMS could become the norm. “I think companies are really nervous based on his track record,” an industry insider said.

Peter Pitts, co-founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, argued the drug lobby’s fears are unfounded. “I don’t think you’ll see more strident regulations,” Pitts said. “I think you’ll see a more effective way to use existing regulations.”

He anticipates FDA will experience an influx of resources this year that will have the underfunded agency running smoother and more efficiently.

One lobbyist called the new funding on the horizon “a blessing and a curse,” adding, “With that money, the question is: What type of additional oversight or regulatory burden [is] not going to be put on just pharma-companies but biotech and medical device companies as well?”

Edney notes that Waxman is a leader in trying to move legislation that would grant FDA the authority to oversee tobacco, a bill Sharfstein worked on with the chairman, as well as his most recent legislation that would allow FDA to approve generic versions of biologic drugs.