A Manner of Speaking

During all of last year, FDA issued 18 “general announcements” via press release to discuss agency actions on policy issues, announce a point of view or enunciate a policy issue. Two of those from last year included statements that came from the FDA Commissioner – Robert Califf, as well as one that went out in January of this year while he was still commissioner, totaling three for the time that he was Commissioner. 

By comparison, this year, FDA has so far issued 41 “general announcements” via press release, 23 of which were statements from Commissioner Gottlieb, whose nomination was confirmed in May of this year. It demonstrates a whole new approach to communications by the new head of FDA. That isn’t a bad thing – it accomplishes a few important goals.

First, it displays a commitment to some level of openness about what FDA is doing and why it is doing it. Second, it also demonstrates a commitment to multiple stakeholders that the head of the agency is “hands on” and not leaving matters to others – in short – signaling that he knows what is going on across the wide spectrum of the regulatory charge of the agency he heads. Next the statements allow him to draw emphasis to his point of view for the media on specific topics – to take a hand in shaping any story by providing comment proactively. 

And last, but certainly not least, the Commissioner is putting a big arrow to guide members of Congress, and their staffs, regarding progress the agency is making on multiple fronts. Throughout the confirmation process there were mentions of multiple policy priorities – from addressing the opioid epidemic to pricing to concern about regulatory burden. And perhaps one of the most pressing policy issues – spurring innovation and getting new products to patients – has been a particular priority.

Included among the 23 statements from the  Commissioner were several regarding developments on various aspects of the opioid problem, oversight of stem cell and regenerative therapies, progress on the Hurricane recovery front, efforts of the agency respecting the practice of compounding, getting patient input into FDA work, streamlining development pathways, and announcing a practical approach to menu labeling.  

Both through the combined effect of these pronouncements as well as the individual missives themselves, there is most certainly not only a comprehensive span of issues being addressed, but there is a sense of momentum along all fronts. Grass is not growing under his feet. For a number of reasons, it is good to make others aware of the fact.