I'm sure we all remember the industry's cool response when Dr. Sharfstein joined the FDA. This week brought news that he will be leaving the Agency.

His tenure must have been as challenging as it was brief (I'm picturing the J&J recall hearings, in which an outspoken critic of some industry practices took some sharp and very public criticism). 

But one wonders whether frustration wasn't what really motivated his career move. Dr. Sharfstein had chaired FDA's Transparency project, which aims to make the Agency's operations and its rationale for decisions more understandable to the public and to industry.

Was transparency simply too challenging to discuss, much less achieve, for an "outsider" and a change-agent working within the Agency?  Was there simply too little trust, or willingness to work for change, entrenched in some longtime FDA staffers? 

On the surface, the whole effort might have appeared much like many unfortunate corporate "diversity" programs---an empty "feel good" PR exercise.  But in fact it aims to solve a major problem that continues to hurt FDA's reputation among public, leadership of regulated industries and lawmakers, as borne out by recent surveys by PWC.  

Internal FDA staff "transparency" reviews were in progress during the first quarter of last year, when the "public" phase of the transparency project was launched.  Reviewer's productivity was one of the KPI's being measured (just as employee productivity would be measured at any organization).

Yesterday,  FDA formally launched the industrial outreach prong of the program with a related website for the industries it regulates.  

What does it say about the organization's culture, and what Sharfstein had to face every day,  that it took five years for FDA, birthplace of pharma GMPs and acknowledged as one of the world's most stringent regulatory agencies,  to be formally accepted into the global Pharmaceutical Inspectorate  PIC/S...when the time limit for such applications is reportedly six years?

FDA was accepted into PIC/S just before the Ukraine (a place where, according to some reports, 80% of some pharmaceuticals on the market may be counterfeit, and, one presumes, pharma GMPS are in their infancy). 

A very interesting report that came out recently from PDA spoke volumes...it quoted FDA's Brenda Holman on how complex the PIC/S membership application process proved to be.  Each department within FDA reportedly filled out the PIC/S application and "threw it over the wall..." 

(Not, typically, the way to speed up any process depending on collaboration and transparency...is this why FDA has felt compelled to engage McKinsey, Light Pharma et al instead of taking a more rigorous look internally? Didn't the Lean teambuilding staff exercises of the last decade do anything to change the culture there, or does FDA merely continue to mirror the silos within the companies it regulates? )

Unfortunately, the unusually candid interview with Ms. Holman, which was there only a few days ago,  is no longer on PDA's website (although it has been widely reported on).

However, as the previous post notes, Commissioner Hamburg introduces the new phase of FDA's transparency initiative  in a video, suggesting top-level commitment to change and improvement within FDA.  If the transparency project continues to receive Commissioner-level attention, then maybe it will achieve its goals. Unfortunately, it will do so without someone who might have gotten it there quite a bit sooner.

AMS