FDA Commissioner Hamburg To Step Down at the End of March
February 5, 2015 in News
On Thursday, FDA Commissioner Margaret Hamburg, who has overseen several health IT initiatives, announced that she will step down at the end of next month, the New York Times reports.
Hamburg’s Efforts at FDA
Hamburg worked as head of the agency for nearly six years (Tavernise, New York Times, 2/5). During her tenure as commissioner, Hamburg oversaw public health initiatives, including:
- Food safety;
- Personalized medicine; and
- Tobacco control (Dvorak, FierceHealthIT, 2/5).
Hamburg and FDA also played a key role in creating a regulatory framework for digital health (Pradhan, Politico Pro, 2/5).
For example, FDA in January published two draft guidance documents that outlined how the agency would classify low-risk general wellness devices and applications and propose risk assessment-based regulation for medical devices:
- In one draft guidance, FDA detailed what it would qualify as a low-risk general wellness product, which would not be subject to the agency’s regulation; and
- In a separate draft guidance, the agency defined a medical device accessory as something that is used with at least one parent device or is “intended to support, supplement and/or augment the performance of one or more parent devices” (iHealthBeat, 1/20).
FDA also has been piloting a program that uses electronic health records and claims data to monitor the safety of medical products regulated by the agency in an effort to improve patient safety (iHealthBeat, 1/5).
Details of Resignation
Hamburg announced her resignation in an e-mail to staff and said she would leave at the end of March (Politico Pro, 2/5).
In the e-mail, she said that her time at FDA has been the “most rewarding” experience in her career, noting that it was “with very mixed emotions” that she made the decision to leave (FierceHealthIT, 2/5).
Stephen Ostroff, chief scientist at FDA, will serve as acting commissioner when Hamburg leaves (Politico Pro, 2/5).