FDA Principal Deputy Commissioner Josh Sharfstein graced the luncheon dais on the final day (Wednesday) of AdvaMed’s third annual shindig.
Following a video welcome from his boss, FDA Commissioner Peggy Hamburg (who advised the audience they weren’t obligated to laugh at any of Josh’s jokes), Dr. Sharfstein spoke about the five issues driving reform over at CDRH. They are:
(1) The development of predictable pathways. Good to hear that the corner office understands that predictability is an important public health issue.
(2) 510(k) reform (and the IOM study of same). Josh noted that “not everyone” was unhappy with the status quo.
(3) Development of a comprehensive compliance strategy. Urgent since the absence of such a program dilutes credibility for both regulator and regulated.
(4) A total lifecycle approach to post-market safety. A la REMS – this (at least in theory) gives the agency greater comfort to approve riskier products.
(5) Better communication of why (and how) CDRH reaches its decisions. This jives with the agency’s broader transparency initiative (which is being coordinated by Sharfstein).
Josh lauded Acting CDRH Director Jeff Shuren, noting that he (Jeff) wasn’t just keeping the seat warm until a permanent director can be appointed, but had the full faith and authority of the Commissioner to drive the above five-pointed program forward.
Jeff Shuren is a serious guy and whip-smart. An MD and a JD – he now completes the triad as (acting) indian chief.
Following a video welcome from his boss, FDA Commissioner Peggy Hamburg (who advised the audience they weren’t obligated to laugh at any of Josh’s jokes), Dr. Sharfstein spoke about the five issues driving reform over at CDRH. They are:
(1) The development of predictable pathways. Good to hear that the corner office understands that predictability is an important public health issue.
(2) 510(k) reform (and the IOM study of same). Josh noted that “not everyone” was unhappy with the status quo.
(3) Development of a comprehensive compliance strategy. Urgent since the absence of such a program dilutes credibility for both regulator and regulated.
(4) A total lifecycle approach to post-market safety. A la REMS – this (at least in theory) gives the agency greater comfort to approve riskier products.
(5) Better communication of why (and how) CDRH reaches its decisions. This jives with the agency’s broader transparency initiative (which is being coordinated by Sharfstein).
Josh lauded Acting CDRH Director Jeff Shuren, noting that he (Jeff) wasn’t just keeping the seat warm until a permanent director can be appointed, but had the full faith and authority of the Commissioner to drive the above five-pointed program forward.
Jeff Shuren is a serious guy and whip-smart. An MD and a JD – he now completes the triad as (acting) indian chief.
