Mark Mansour, Partner, Bryan Cave, LLP
The FDA and the trade press called Dan Schultz’s departure as head of CDRH a “mutually agreed upon decision” between Schultz and FDA Commissioner Margaret Hamburg. Schultz announced his resignation last week, effective at the end of August. Jeff Shuren, who is the FDA’s associate commissioner for policy and planning, will serve as interim CDRH director.
This isn’t a great surprise, nor is the fact Shuren is his replacement particularly surprising. Shuren has been at the forefront of the effort to remake FDA’s enforcement profile, and Hamburg’s statements taken with the serial changes at the agency over the past several months indicate clearly the direction Hamburg and Deputy Commissioner Joshua Sharfstein intend to go. Shuren and other FDA officials, since last year, have been telling industry that it will have to prepare for a new enforcement environment (this before the 2008 election).
Since Drs. Hamburg and Sharfstein took their posts, a series of announcements punctuated by enforcement activity, and now personnel changes, have demonstrated that the new regime is in confidence rebuilding mode. This means not only enforcement, but faster enforcement.
Earlier this week, CDRH reminded pre-amendments (product categories that were on the market before FDA device regulations were established in 1976) device makers that failure to submit safety and effectiveness information ordered by FDA on 25 device types several months ago could result in seizure, injunction or even criminal prosecution. The submissions were reportedly due to FDA on August 7, and CDRH acknowledged that they were arriving on a fairly regular basis, with some 120 submissions received and more expected.
The devices in question were grandfathered into FDA’s review system as high-risk Class III products, but were not required to undergo PMA safety and effectiveness reviews. FDA retained the option either to accept a Class III designation and mandate PMAs, or to require the devices be reclassified. A number of categories have already been reclassified, but some 25-30 remain in their previous status, which means they can be marketed through the less costly and time-consuming 510(k) process. That is a sore spot for several key members of Congress, and there can be little doubt that FDA is responding those concerns by putting pressure on industry to either submit their applications, or face enforcement action. The next step is for FDA to undertake review, and then once they are deemed sufficient, CDRH will redact and post them online.
For industry, the real next step will be how strict and severe any penalties imposed might be. That and the next enforcement action will give us a better idea of what the new regime’s relationship with industry will look like in the coming years.
Mark Mansour is a partner in the firm, Bryan Cave, LLP
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