FDA Commissioner Resigns

Margaret Hamburg, M.D., who as commissioner of the U.S. Food and Drug Administration (FDA) for nearly six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine and drug approvals, is resigning.
Hamburg, one of the longest-serving FDA commissioners in the modern era, told Reuters in an interview that her decision was prompted by the heavy demands of the job and the sheer length of time she has held the position. “This is a very challenging job full of opportunities to make a huge and enduring difference,” she said, “but it is 24/7 and there are really, really difficult decisions to make.”

The commissioner, 59, was nominated by President Barack Obama and confirmed by the U.S. Senate in May 2009. She was named the world’s 51st most powerful woman by Forbes magazine last year.

Hamburg’s resignation comes at a crucial time for the FDA as Congress pushes initiatives to speed new drug development, and food safety advocates back the creation of a separate agency combining the food safety functions of the FDA and the U.S. Department of Agriculture.

Under Hamburg, the agency made strides to streamline the medical device approval process, reduce regulatory red tape, better train its staff and jump-start U.S. product launches. Last fall, Hamburg addressed attendees at AdvaMed 2014: The Medtech Conference, outlining specific steps the agency currently is undertaking to regain industry trust and win over companies that first seek product approval outside the United States (a three to five-year device approval gap currently exists between Europe and America). For example, the FDA has proposed creating an expedited approval process for medical devices designed to treat life-threatening or irreversibly debilitating diseases or conditions for which there are no other products available. It also is attempting to become more flexible and patient-centric in its decision-making, acknowledging the limitations of its current binary system.
While Hamburg admitted the FDA still has many challenges to overcome, she fired off a list of accomplishments in the resignation letter posted on the agency’s website.

“On the medical device side, the average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010,” Hamburg wrote. “The percentage of pre-market approval (PMA) device applications that we approve annually has increased since then, after steadily decreasing each year since 2004. We also published the Unique Device Identification final rule that is intended to improve the tracking and safety of medical devices. And we proposed a risk-based framework for laboratory developed tests to help ensure patients and providers have access to safe, accurate and reliable tests, while continuing to promote innovation of diagnostic tests to help guide treatment decisions.”

Other improvements in the device arena include changes to the de novo classification process that has considerably reduced review times from an average of more than 700 days several years ago to the current average of 166 days. Also, pre-market approval (PMA) backlogs have been cut in half, and the percentage of PMAs with deficiency letters have fallen as well.

The Advanced Medical Technology Association (AdvaMed) commended Hamburg for her leadership in negotiating the Medical Device User Fee Agreement III, which provides the FDA with $595 million in funds over five years, enabling the agency to hire additional reviewers, lower the ratio of managers to reviewers and enhance training for reviewers.

“We commend Commissioner Hamburg for her years of dedicated service to FDA and to American public health,” said Janet Trunzo, AdvaMed’s senior executive vice president for technology and regulatory affairs. “It was under her leadership that the historic Medical Device User Fee Agreement III (MDUFA III) was struck, bringing significant new resources, accountability and improvements to the device review process. Much progress has been made, and her legacy will continue in the ongoing program which ensures timely patient access to the best in medical care. In addition, she was a key advocate to strengthen oversight for certain laboratory-developed tests which have become far more complex and critical to patient care and medical decision making.”

White House spokesman Josh Earnest said Obama’s nomination to replace Hamburg would have impeccable scientific credentials and merit bipartisan support. The nominee must be confirmed by the Republican-controlled Senate.

Late last month, the agency named Robert Califf, M.D., a prominent cardiologist and researcher from Duke University, to oversee its drug, medical device and tobacco policy. Califf is viewed by many as a potential successor to Hamburg, whose resignation takes effect March 31.

Stephen Ostroff, M.D., the FDA’s chief scientist, will fill Hamburg’s position until a new commissioner is named.

A long-time public health official with extensive experience fighting AIDS and tuberculosis, Hamburg, a Harvard Medical School graduate, previously served at the National Institutes of Health before becoming New York City’s health commissioner. That public health focus endeared her to patient advocates.

During Hamburg’s tenure, the FDA has confronted major public health issues, including the rise of antibiotic-resistant bacteria, the abuse of opioid painkillers, the emergence of electronic cigarettes and the outbreak of Ebola and other infectious diseases.