Meet The New Transparency – Same as The Old Transparency

By Jeffrey K. Shapiro –

We are beginning to suspect that the new transparency of this Administration is a lot like the old transparency.  Or, as The Who sang in We Won’t Get Fooled Again, “meet the new boss / same as the old boss.”

The most recent example:  On April 12-13, the Regulatory Affairs Professionals Society ("RAPS") is holding an FDA-industry meeting in Rockville, Maryland.  The well respected RAPS organization had scheduled this program in close cooperation with FDA more than six months ago.

FDA had agreed to have Heather Rosecrans and Marjorie Shulman, who run the Premarket Notification (510(k)) Section in the Office of Device Evaluation ("ODE"), speak at the program.  They were scheduled to appear on two panels, Device Classification, Strategy and Pre-Submission Research and Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(k)s. 

These panels are intended to help regulatory affairs professionals learn more about how to interact with FDA on 510(k)s and how to craft and submit successful 510(k) filings.  Ms. Rosecrans, in particular, has spoken frequently to industry groups over many years and has always been a popular and highly regarded speaker.

At the last minute, management at the Center for Devices and Radiological Health ("CDRH") pulled the plug.  They refused to clear either Ms. Rosecrans or Ms. Schulman to speak.  Instead, CDRH management offered up replacement speakers from the Division of Small Manufacturer, International and Consumer Assistance ("DSMICA").  These speakers do not run the 510(k) program and are by necessity not as well versed in it as those actually run the program.

Hyman, Phelps & McNamara, P.C. is not sure what to make of this precipitous last minute withdrawal of scheduled FDA speakers.  Perhaps it has something to do with the 510(k) review now underway.  Yet, the RAPS program was supposed to address the existing 510(k) program, not potential changes.  Removing these speakers deprives industry of a chance to better understand FDA’s current 510(k) program.  This loss of information will deprive industry of the benefit of knowing what FDA is really looking for in 510(k) submissions, and conversely, will burden FDA with 510(k) submissions that are not as well put together as they otherwise might have been.

This mysterious action seems out of sync with FDA's renewed commitment to transparency.