FDA chief steps down
After six years at the top, Margaret Hamburg, MD, will resign her post as commissioner at the FDA in March.
During her time at the helm, Hamburg oversaw approvals of increasing number of medical devices, with pre-market review waiting times being reduced by approximately a third since 2010.
The appointment of a successor will come from President Obama. In the meantime, Stephen Ostroff, the agency’s chief scientist and a former official at the Centers for Disease Control and Prevention, will act as interim commissioner.
In a personal statement on the FDA website Hamburg reflected on her time in the position:
"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. 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 (UDI) 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 (LDTs) 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."
On the subject of drugs, she added:
“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.
“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.”