Pharmaceutical

FDA commissioner Hamburg to step down in March

Margaret Hamburg official portrait 168x210 FDA commissioner Hamburg to step down in MarchFood and Drug Administration (FDA) Commissioner Margaret Hamburg announced she is resigning from the agency after nearly six years at the helm. Hamburg did not give a reason for leaving office, though her tenure as chief at times was marked by controversy.

The agency’s lead scientist, Stephen Ostroff, who joined the FDA in 2013, has been named acting commissioner.

Hamburg’s resignation comes in the wake of the agency’s controversial approval of the powerful opioid painkiller Zohydro, which sparked petitions and heated disapproval from health advocates and politicians who argued that approving the first and only pure hydrocodone painkiller would only contribute to the growing prescription drug abuse and misuse epidemic. Hamburg stood firm to her stance that people in pain deserved more treatment options and while hydrocodone was currently available in formulations with other drugs such as acetaminophen, many patients are at risk of liver failure from acetaminophen toxicity.

Hamburg’s resignation letter to staff did not focus on the negative; rather, she highlighted much of the progress that has been made by the agency.

“As you can imagine, this decision was not easy,” she wrote. “While there is still work ahead (and there always will be), I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success.”

Hamburg’s letter highlighted the agency’s efforts to improve food labeling by restricting trans fats, defining “gluten free” labeling, and proposing updated nutritional facts labels. Under Hamburg’s helm, the FDA has also issued regulations to expand its oversight of novel tobacco products, such as e-cigarettes.

Sen. Lamar Alexander said of Hamburg’s departure that he was grateful for her leadership, adding, “We worked well together to find a solution that would help prevent another compounding crisis after the 2012 fungal meningitis outbreak that killed 64 people. … I hope 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.”

Hamburg expressed confidence in Dr. Ostroff as her successor. He will take over as acting commissioner when Hamburg leaves office in March.

Source: Law 360