Sharfstein to Leave FDA

The natural products industry interacted with FDA Deputy Commissioner Joshua Sharfstein far more than it did FDA Commissioner Margaret Hamburg. Effective Jan. 12, Sharfstein will be Marylands top public health official, leaving FDA after almost two years of battles with drug companies and increased enforcement efforts against not only companies but their executives.

Sharfsteins legacy at FDA was not just medical device regulation, but also a grasp of important supplement issues, as well as an overall increased transparency and interaction between agency and industry.

I dont think that there has ever been a senior FDA official that was willing to engage the supplement industry in the way he has, said Marc Ullman, partner with Ullman, Shapiro & Ullman and legal advisor for the Natural Products Foundation (NPF). Dr. Scharfsteins clear, concise testimony before the Senate Special Committee on Aging where he explained the structure of DSHEA and the need to balance regulatory authority with consumer access to supplements was something that we had never heard from anyone at FDA before and may never hear again.  Given this, Ullman speculated Scharfsteins departure from FDA will result in the supplement industry slipping even lower on the agencys list of priorities.

In reflecting on Sharfstein's impact, John Gay, executive director and CEO at the Natural Products Association (NPA), also referenced Sharfsteins testimony to the Special Committee on Aging, when the deputy commissioner said the issue of tainted supplements kept him up at night. We approached him and asked what his thinking was on this issue and how industry and FDA could work together on this, Gay said, noting Sharfstein responded positively. I appreciated his understanding that there is a good dietary supplement industry that has a problem with bad actors, Gay noted, adding Sharfstein never demonized the industry.

Sharfstein was willing to listen to the industry, which is something not every top regulator does. While he will be missed for these positive attributes, Sharfstein leaves behind a capable FDA staff well-versed in dietary supplement issues. It is not a case of losing all the brainpower on an issue, and you have to start from scratch, Gay offered. This is not the end of our relationship with FDA.

What is your take on Sharfsteins departure?