I’m not suggesting there was dancing in the streets, but the resignation of Joshua Sharfstein was probably followed by a collective sigh of relief (and maybe a shout of joy) from medical device manufacturers.

Heather Thompson

January 27, 2011

3 Min Read
A Belated Holiday Present to Industry: Sharfstein Is Out

HT_HS.gifFDA has had trouble keeping its leadership positions filled. In the last 10 years, the agency has seen four commissioners take the reins. Margaret Hamburg now holds the position, but her deputy, Joshua Sharfstein has resigned to take a job as secretary for the Department of Health and Mental Hygiene in the state of Maryland. His last day at FDA was January 7.

Sharfstein’s legacy is his shake-up of the agency and medical device industry. His leadership set the tone for FDA. In his brief time as acting commissioner, Sharfstein aggressively addressed safety issues, such as the clearance of ReGen Biologics Inc.’s Menaflex knee implant. Sharfstein’s probe into the device ultimately led to the rescission of the implant’s clearance for market, and it set the tone for a very different FDA from what industry had seen in the past.

Furthermore, through Sharfstein’s influence, FDA began a controversial transparency initiative that makes public sensitive data from clinical trials and therefore available for use in lawsuits.

With such activities, Sharfstein has not been popular with industry—indeed, no one would ever accuse him of courting FDA-regulated markets.

Sharfstein “spent the last two years overreaching to expand FDA authority and recognized he would be left to defend those actions for the next two years, so he moved on,” said one FDA observer at the JP Morgan Chase conference that took place in San Francisco in January. The speaker asked to remain anonymous. “He’s been pushing hard and, in many areas, may have gone beyond statutory authority. I know others who felt he was someone who had an antiindustry slant,” he said.

For the record, Sharfstein has stated that he simply felt the position in Maryland was too good to pass up, and that his resignation had nothing to do with the changing political climate.

My personal view is that Sharfstein swung the pendulum for a much-needed dose of integrity in FDA. What I mean is, at least you knew where he was coming from.

Sharfstein’s ideas about transparency may not have been popular or fair, but they were honest. “My opinion about Sharfstein—and FDA in general—is that they are predictably onerous and very transparent about it,” says Mark DuVal, president of DuVal & Associates.

It may be that FDA needed this influx of antiindustry to counteract the sour notes left by Lester Crawford and Andrew von Eschenbach. Crawford’s alleged conflicts of interest, and von Eschenback’s involvement with the ReGen’s initial 510(k) approval, were disheartening to the public that looks to FDA to keep them safe.

And industry may well benefit from the ideas Sharfstein brought to the 510(k) process. Recommendations such as simplifying de novo, streamlining IDEs, and demanding better training for FDA reviewers will undoubtedly help the medical device industry position its products for market and make the clearance process easier to understand.
Nonetheless, now it’s time for the pendulum to balance. Hamburg’s temporary choice for the deputy appointment may just fit that description.

John Taylor III, Counselor to the Commissioner, was named acting principal deputy commissioner on the day of the official announcement of Sharfstein’s departure. Taylor is decidedly less controversial, but he is also very well respected, having worked in the industry for 20 years, at FDA, the Biotechnology Industry Organization, and at Abbott Laboratories. He may have better access to a GOP-run House than Sharfstein would have.

Taylor is also a good choice, reputation-wise, because the last time he worked at the agency, Mark McClellan was in charge. “John Taylor is a classy, measured, and articulate individual,” says DuVal. “He will understand FDA’s position as well as industry’s point of view.”

Let’s hope Taylor’s brand of reasonableness and integrity will become the norm rather than the exception at the agency going forward.

Slide photo courtesy of Bloomberg News/Landov

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