FDA’s Sharfstein highlights transparency gains

Josh Sharfstein, outgoing Principal Deputy Commissioner, FDA

wfedstaff | June 3, 2015 7:28 pm

Lack of transparency can lead to a lot of misinterpretation.

That’s what happened before he joined the Food and Drug Administration, said outgoing Principal Deputy Commissioner Josh Sharfstein.

“If the agency doesn’t really aggressively explain itself, make information available, make itself available, then it’s just ripe for that kind of misinterpretation,” Sharfstein said in an interview with the DorobekINSIDER before he leaves his post as number two at FDA.

Sharfstein leaves a legacy of bringing major changes to performance and transparency to FDA. One example — the FDA TRACK website. TRACK stands for transparency, results accountability, credibility and knowledge-sharing.


The site measures performance at more than 100 FDA offices on key projects with monthly updates, Sharfstein said. Managers at these offices also meet quarterly with FDA commissioners to give status updates on performance goals. The meetings allow commissioners to offer guidance if an office is having problems meeting goals, he said.

“it’s a two-way street,” he said.

Bringing greater transparency to the agency meant first determining what data should be public. FDA compiled a report that “walked through balances that must be struck,” Sharfstein said.

In preparing the report, FDA held public meetings that brought together different stakeholders, such as consumer groups and industry. FDA would give food scenarios and get feedback from the participants.

“We got a lot of back and forth from the public on that that helped us to try to draw the line,” Sharfstein said.

He added, “There’s much more agreement. Oftentimes, its just where you draw the line. People really do understand that there’s a value to transparency, there’s a value to confidentiality, let’s have a chance to have some interaction.”