A Long Tenure
Hamburg’s resignation brings to an end one of the longest tenures as FDA Commissioner of Food and Drugs in the agency’s history. According to data analyzed by Regulatory Focus, Hamburg will be the sixth-longest serving FDA commissioner in history, the longest-serving (and only the second) female commissioner in the agency’s history, and the second-longest-serving commissioner of FDA’s modern regulatory era.
Assuming Hamburg leaves office on 28 March 2015, she will have served in office for 2,140 days. She was sworn into office on 19 May 2009, and had been the only FDA commissioner to serve under President Barack Obama.
An Agency in Flux
Hamburg’s tenure as commissioner has been marked by a number of high-profile changes, struggles and scandals.
She was brought on in the early days of Obama’s push for the Patient Protection and Affordable Care Act (PPACA), which established a regulatory pathway for biosimilar products. In 2011, tensions flared between her and Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius after FDA’s approval of an over-the-counter birth control product was overturned for reasons that appeared to be more political than scientific.
Hamburg has also overseen massive legislative changes at FDA. The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) created hundreds of new obligations for the agency, and also established several new pathways for approvals, such as the breakthrough therapy designation. The 2013 Drug Quality and Security Act gave the agency broad new powers to ensure the safety of the pharmaceutical supply chain and of compounded pharmaceutical products.
Drug and device approvals also saw marked improvements under Hamburg’s tenure, with new drug approvals experiencing perhaps their best year for approvals ever in 2014, and device approvals making slow but steady improvements.
Hamburg also oversaw scandals and problems at FDA during her tenure. FDA was chastised for its lack of oversight of the pharmaceutical compounding industry, for allegedly spying on some members of its medical device review divisions, for its approach to regulating painkillers, and for its regulation of various products and areas.
Hamburg’s departure comes at a particularly tricky time for FDA. Both the House of Representatives and Senate are pursuing new legislation aimed at expediting the processes FDA uses to approve most drugs, and particularly those for patients with rare or life-threatening diseases. The legislation could have a massive effect on the way in which FDA regulates almost every medical product it oversees.
In addition, the agency is preparing to enter into negotiations with the pharmaceutical and medical device industries regarding user fees. Under various pieces of legislation—the Prescription Drug Use Fee Act, the Medical Device User Fee Act, the Generic Drug User Fee Act and the Biosimilar User Fee Act—FDA collects fees from pharmaceutical and medical device companies to help it hire more staff and review new product applications more quickly. In return for that money, FDA is supposed to adhere to specific timelines for reviewing products. The negotiations, which notably do not involve Congress, are meant to ensure FDA gets sufficient funding to make improvements, and that industry is assured its funding—which now makes up more than half of all funding at FDA—is actually resulting in more efficient regulatory reviews.
But even more important than what’s next is the question of who’s next.
Ostroff, who will serve as acting commissioner upon Hamburg’s departure, is a relatively little-known regulator outside FDA circles. As of January 2014, he was the chief medical officer of FDA’s food science division, the Center for Food Safety and Applied Nutrition (CFSAN), and an advisor to FDA’s Office of Foods and Veterinary Medicine. Given Congress’ focus on medical products at the moment, legislators might instead push for someone who is able to focus more on reforming and accelerating medical product approvals at FDA.
In a statement, Rep. Fred Upton, who is leading the House’s effort to reform FDA, said he is looking forward to leadership to “ensure we are firmly on the path to cures.” Sen. Lamar Alexander, who is leading the FDA reform effort from the Senate side, said he “hopes the president nominates an FDA Commissioner who will work closely with Congress on finding ways to get safe medical treatments, devices and drugs to patients more quickly.”
Even Obama might be unlikely to appoint an FDA commissioner who is focused on the regulation of food. As reported in late January 2015, Obama has proposed stripping FDA of its authority to regulate food products, which would instead be transferred to a new “Food Safety Administration.”
So who might succeed Hamburg? If rampant speculation is any guide, the agency may already have hired its next commissioner. In January 2015, FDA announced it had hired world-renowned cardiologist Robert Califf to a top role within the agency: deputy commissioner for medical products and tobacco. Califf has been considered for the role of FDA commissioner on two separate occasions.
In appointing his next choice for FDA Commissioner, Obama will also have to grapple with a Republican-controlled House and Senate, both of which might complicate the confirmation process. Hamburg, in contrast, was appointed when both chambers of Congress were overwhelmingly controlled by Democrats.
REFERENCE: RAPS; Regulatory Focus; 05 FEB 2015; Alexander Gaffney, RAC