FDA After Hamburg

It was no surprise that Commissioner Margaret (Peggy) Hamburg decided to call it a day after nearly six years at the helm of the Food and Drug Administration. She has accomplished a great deal during her relatively long tenure leading this high-profile agency, but also has had to withstand constant criticism. The prospect of multiple reform proposals from a Republican-led Congress, limited funding increases from the White House, and the task of launching another round of user-fee negotiations with industry-and associated legislation-were daunting prospects.

Hamburg’s announcement that she would leave FDA at the end of March 2015 generated a wave of kudos from Congressional leaders, industry organizations, medical groups, and the research community. She is praised for emphasizing science-based regulation, for supporting efforts to streamline medical product approvals, for recognizing the challenges from a more globalized food and drug world, and for bringing patients more into the regulatory process. Friends of Cancer Research chair Ellen Sigal noted that Hamburg “changed the direction of the FDA” by encouraging “science-based collaboration.” In a recent summary of agency accomplishments for 2014 posted on the FDA website, Hamburg highlighted the surge in new drug approvals and efforts to curb opioid abuse, to promote new antibiotics, and to facilitate development of vaccines against Ebola and other infectious diseases. She also noted attention to medical product safety, to halting compounding of unsterile drugs, to implementing new controls over tobacco products, and to promoting food safety and nutrition. A lengthy farewell message to FDA staff reiterated these gains and praised their “expertise, dedication, and integrity.”

Changes ahead

Hamburg is departing with two years left in the Obama administration, enough time to nominate and seek Senate approval of another FDA commissioner, if the administration chooses to do so. Or FDA could be left with an acting commissioner for the duration, with FDA chief scientist Stephen Ostroff filling that role after Hamburg leaves in late March.

There has been rampant speculation that Duke University cardiologist Robert Califf would be named to the top spot, following his recent appointment as FDA deputy commissioner for medical products and tobacco. He has served on FDA advisory committees, led important Institute of Medicine studies, supported multiple public-private research partnerships, and championed strategies to modernize clinical research. He also has worked with industry in designing and conducting clinical studies and developing new medicines, experience that might raise some objections from liberal Democrats about a pro-industry bias.

If Califf does face confirmation hearings, he should be able to tap his prominence in North Carolina medical circles, where he has led the Duke Translational Medicine Institute, a large operation that employs hundreds of researchers and scientists. That should generate support from Sen. Richard Burr (R-NC), a prominent member of the Senate and of the Health, Education, Labor and Pension (HELP) Committee, which handles FDA confirmation. Laksman Ramamurthy, director for FDA regulatory policy at Avalere Health, says he’s optimistic about Senate confirmation of a new FDA commissioner, as Senate Republicans will want to prove that they can make government work running up to the 2016 presidential elections.

Even if the White House decides to avoid a battle over FDA’s functions and future, Califf will play a prominent role in leading FDA over the next two years as it continues to face new challenges. While there is enthusiasm for accelerating the approval of more “breakthrough” drugs, that program may draw more scrutiny as some initial breakthroughs prove to be less effective than expected. There is pressure on FDA to do more to assess the cost-effectiveness of new medical products and to ensure the safety of the growing volume of medicines and foods imported from abroad. One FDA initiative that may fall by the wayside is the agency’s recent move to regulate laboratory-developed tests, which is strongly opposed by independent test laboratories as well as the medical community. And medical diagnostic firms remain nervous about how FDA proposes to monitor new technologies.

The Center for Drug Evaluation and Research is working overtime to implement recent legislation that sets new rules pharmacy compounding and for tracking the distribution of prescription drugs. Republicans in the House and the Senate have offered lengthy proposals for reforming FDA operations and policies, most notably the “21^st Century Cures” package from the House Energy & Commerce Committee. The new (acting) commissioner will have to deal with these and many more issues.