The Sharfstein Years
As you’ve heard by now, FDA Deputy Commissioner Dr. Joshua Sharfstein is leaving his post at the FDA to become secretary of health and mental hygiene for Maryland. The blogosphere’s abuzz over what Sharfstein’s move means for the FDA and industry at the top of a new Congress, but amidst the speculation, we wanted to take a minute to review some of what Sharfstein did on the drug side of things during his two years at the agency. From an admittedly long and uncountable list, he:
–Oversaw an increase in the number of domestic and foreign inspectors
–Moved to collaborate with industry and lawmakers on improving supply chain security and oversight
–Launched the FDA transparency initiative, a three-phase process to lift the shroud of bureaucracy a bit (more on that soon)
–Engaged the agency in developing social media guidelines for drug and device makers (we await a final guidance).
In fact, Sharfstein was making waves at the FDA prior to being named deputy commissioner. As health commissioner in Baltimore, he and a group of fellow pediatricians filed a citizen petition in 2007 asking the FDA to reconsider the approval of over-the-counter cough and cold meds for small children, citing years of morbidity data and a lack of studies that showed the drugs to be safe or effective. The high-profile case led to manufacturers pulling under-2s’ cough and cold meds off the shelf–a move that was linked in Pediatrics last month in to a drop in related emergency room visits. (To date, we await the FDA’s final ruling on those products.)
In his post as deputy commissioner, Sharfstein was often the voice of the agency’s drug authority, and at a series of Congressional hearings on drug safety bills, heparin, and the J&J recalls, it was a guiding one. He came to the witness stand informed, open, willing to ask for things that the agency needed. As a physician, Sharfstein had the clinical experience and credibility to sign off on advisory committees’ important–and often contentious–approval and post-market debates. As a former Hill staffer, Sharfstein knew what could be done legislatively and how, and Members in turn offered bills that would give the agency authorities and resources that Sharfstein saw were needed.
And as a public health expert, Sharfstein helped recalibrate and rearticulate the agency’s mission in terms of protecting the public health through prevention, transparency, and collaboration. As Mark Senak at Eye on the FDA put it, Sharfstein’s and Commissioner Hamburg’s appointment signaled “that the agency was effectively turning a corner – that public health was the driving force and if you wanted to communicate effectively with the agency, framing a discussion–whether a drug approval or safety considerations or a policy decision – should be in public health vernacular.”
As a new Congress takes over the gavels, the clamor for faster approvals is growing, and several Members of Congress have suggested they intend to do some bureaucracy-busting on the historically beleaguered FDA. We hope that amidst these changes the agency can and will continue to focus on public health the way Sharfstein has, and carry out current initiatives and address new challenges in that spirit.
–Kate Petersen, PostScript blogger