FDA commissioner resigns position after six years

FDA Commissioner Margaret A. Hamburg, MD, whose tenure has ushered in the era of personalized medicine and seen faster approval of several classes of drugs by such means as breakthrough drug designation, accelerated approval, and wide use of easier end points in research, is resigning her position after six years in the job.

Margaret A. Hamburg, MDFDA's Chief Scientist Stephen Ostroff, MD, has agreed to serve as Acting Commissioner when Dr Hamburg steps down at the end of March.

Dr Hamburg became the 21st commissioner of food and drugs on May 18, 2009. The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive.

“Dr. Margaret Hamburg’s resignation as FDA Commissioner, while not expected, does not come as a complete surprise at this point in the Obama presidency,” said Randy Vogenberg, PhD, RPh, partner, at Access Market Intelligence, and principal, Institute for Integrated Healthcare, Greenville, S.C. “Hamburg has been one of the longest-serving FDA commissioners.”

Late last month, the agency named Robert Califf, MD, a prominent cardiologist and researcher from Duke University, to oversee its drug, medical device and tobacco policy. According to Vogenberg, Califf, a past candidate for commissioner, is viewed as a potential successor to Hamburg.

“Another potential candidate would be Dr. [Joshua] Scharfstein from Maryland who briefly served with Hamburg at the FDA then left to return to Maryland,” he said.

“Politically speaking, Dr. Hamburg’s resignation comes at a time for changes for the FDA, as Congress looks to accelerate drug development, and the president, who would like to see the creation of a separate agency combining the food safety functions of the FDA and the U.S. Department of Agriculture,” Vogenberg continud. “As a result, the choice of a new Commissioner would signal which direction FDA is headed along with the implications for new drug development and its impact on formulary decision makers in hospitals, health systems, and health plans.”

Related: FDA drug approvals

In a letter Hamburg sent to FDA employees, she wrote: “We have . . .made great strides in advancing the safety and effectiveness of medical products. Some of these important steps include new oversight of human drug compounding and provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

“We are continuing to increase the speed and efficiency of medical product reviews. We just had another strong year for novel drug approvals, with most of these drugs being approved on or before their PDUFA goal dates and most being made available to patients in the United States before they were available to patients in Europe and other parts of the world,” she wrote. “We launched a powerful new tool to accelerate the development and review of ‘breakthrough therapies,’ allowing FDA to expedite development of a drug or biologic to help patients with serious or life-threatening diseases.  In fact, almost half of the novel new drugs approved in 2014 received expedited review with a combination of breakthrough designation, priority review and/or fast track status.  These included drugs for rare types of cancer,hepatitis C, type 2 diabetes and idiopathic pulmonary fibrosis, as well as a number of groundbreaking vaccines. We have also established a regulatory pathway for biosimilar biological products that will create more options for patients.”

Related: Adoption of fast-growing biosimilars segment essential

Hamburg graduated from Harvard Medical School and completed her residency in internal medicine at what is now New York–Presbyterian Hospital/Weill Cornell Medical Center. She conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.