In lieu of the Weekly Roundup this week, the report is dedicated to a sole development – the announcement by Dr. Margaret Hamburg of her departure from FDA after six years as FDA Commissioner. She leaves behind a number of accomplishments and an FDA that is in considerably better shape than the one she took over in 2009.
Prior to her arrival, the agency that regulates approximately one-quarter of the U.S. economy had seen a series of commissioners, some with very short tenures. Between 2000 and 2008 there were many months where there was only a commissioner in an “acting” capacity. In addition, during that time, there were many high profile issues that served to shake public confidence in the organization – high profile drug recalls, an episode where politics appeared to interfere with science to keep at bay an RX to OTC switch of a contraceptive; influenza vaccine found contaminated by British authorities rather than FDA; a salmonella outbreak where it took months to resolve the source.
Since taking over the helm of FDA, Dr. Hamburg has taken steps to restore confidence and provide a continuity of leadership the likes of which the agency has not seen for a long time. Early on she instituted an expansion of transparency within FDA with the launch of FDATrack. During her tenure FDA moved to new quarters that could more reasonably house the activities and staff of the agency. The agency saw its authority extended to regulate tobacco and has been putting into place the machinery for doing so. FDA responded to the burgeoning area of medical app and wearable device development by carving out responsible oversight. Legislation paved the way for the construction of a regulatory pathway for biosimilars which is now underway. But perhaps most importantly, FDA has put into place mechanisms to not only facilitate drug approvals, but the approval of drugs for rare and life-threatening conditions with the advent of Breakthrough Therapy status and Priority Review. During 2014, FDA had approved the most drugs of any year in the past ten and more approved during the past five years by far than the five previous to her arrival.
That leaves some big shoes to fill for the next Commissioner.The biosimilars regulatory landscape needs to be filled out, with policy questions open on that front. Proposals are being floated to take the F out FDA and move food safety to an independent agency. And even though the pace of drug approval has hastened, and there are calls among many policy makers for measures that would speed development up even further, a goal always challenged by concern for safety.
The work has doubtless been difficult, but rewarding. Congratulations to Dr. Hamburg and best wishes.
You can see a list of past FDA Commissioners here.