Industry welcomes Stephen Ostroff as acting FDA commissioner

WASHINGTON — The pharma industry on Thursday honored and praised Food and Drug Administration commissioner Margaret Hamburg, following her announcement that she would resign in March, and welcomed Stephen Ostroff, FDA chief scientist and former Centers for Disease Control and Prevention executive, who will assume the role of acting commissioner until the next commissioner is nominated by President Barack Obama.  

 

Ostroff joined FDA in 2013 as chief medical officer in the Center for Food Safety and Applied Nutrition and senior public health advisor to FDA’s Office of Foods and Veterinary Medicine.

 

Prior to that he served as deputy director of National Center for Infectious Diseases at the Centers for Disease Control and Prevention, where he was also acting director of CDC’s Select Agent Program. He retired from the Commissioned Corps of the U.S. Public Health Service at the rank of Rear Admiral (Assistant Surgeon General). Ostroff was the director of the Bureau of Epidemiology and Acting Physician General for the Commonwealth of Pennsylvania and has consulted for the World Bank on public health projects in South Asia and Latin America.

 

Ostroff graduated from the University of Pennsylvania School of Medicine in 1981 and completed residencies in internal medicine at the University of Colorado Health Sciences Center and preventive medicine at CDC. 

 

While industry looked forward to working with Ostroff, pharma associations praised the work of Hamburg. 

 

“PhRMA salutes the work of Commissioner Hamburg and recognizes her significant contributions to the thoughtful regulation of medicines, including science as a basis for better regulatory decisions," said John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America. "For nearly six years, and to the direct benefit of patients, Commissioner Hamburg has demonstrated strong leadership and an unwavering commitment to collaboration with all stakeholders."

 

“During her tenure, the agency has made important progress toward expanding consumer care through OTC medicines — in particular with prescription-to-OTC switches," added Scott Melville, president and CEO for the Consumer Healthcare Products Association. "Just in the last two years, the FDA has approved four successful switches, and we are very optimistic about additional opportunities for future switches," he said.

 

“The Generic Pharmaceutical Association and its members applaud the significant progress made by the agency during Commissioner of Food and Drugs Dr. Margaret Hamburg’s six years leading the U.S. Food and Drug Administration," the association representing generic drug manufacturers released in a statement Thursday. "Commissioner Hamburg has been an advocate on the front lines for passage and implementation of the Generic Drug User Fee Amendments, a historic collaboration between the industry and agency that enhances drug safety, access and transparency. ... She has also been instrumental in the passage and implementation of the Biosimilars User Fee Amendment. Dr. Hamburg’s efforts have been particularly important in this area as the first biosimilars will soon be available in the United States."