New FDA Leadership Focuses on Regulation and Enforcement

Soon after being sworn in, President Obama called for a “complete review” of practices and operations at the Food and Drug Administration (FDA).(1)  Since his new FDA Commissioner Dr. Margaret Hamburg was confirmed by the Senate in May, the agency leadership has made clear its intention to increase its oversight of FDA-regulated industries in the coming years.  Reflecting these new priorities, in the first six months since Hamburg’s confirmation, the agency’s new senior management has made good on its promise, both by closely examining premarket activities at FDA as well as ramping up enforcement efforts.  As the agency moves forward with these initiatives, the medical device industry should be prepared for continued scrutiny and tougher regulation.

Commissioner Hamburg’s priorities for the FDA were first highlighted in an August speech, and appear to provide a backdrop for her tenure at the agency.  Hamburg noted that her goal of creating a strong agency that protects public safety requires “effective enforcement against violations of the law.”(2)  Urging vigilance on the part of FDA, Hamburg outlined  initial steps for improving enforcement at the agency, including: giving firms less time to respond to an inspection; issuing warning letters more quickly or taking action without warning in instances of egregious violations; following up on enforcement actions to assess whether firms made appropriate changes; and developing a warning letter “close-out” process to incentivize corrective action when violations are identified.(3)  Further illustrating senior management’s new philosophy, Hamburg recently appointed a long-standing critic of FDA device regulation policy to a top policy-making position.(4)

FDA’s Center for Devices and Radiological Health (“CDRH”) has followed Commissioner Hamburg’s lead, with plans to review premarket processes and increase enforcement efforts.  Acting CDRH Director, Jeffrey Shuren, recently announced his immediate priorities for the Center, which include re-evaluating the 510(k) premarket notification program and instituting procedures for resolving disputes on regulatory decisions, both in response to accusations that scientific decisions on product approvals have been inappropriately overturned by CDRH leadership.(5)  Similarly, leaders at CDRH’s Office of Compliance have publicly announced their plans to increase enforcement actions.(6)

The new senior leadership’s increased emphasis on regulation has led to the announcement of a formal review of the 510(k) program, following a year of controversy regarding certain product clearance decisions.  An internal review concluded that many aspects of the program have “an uncertain basis” in current law and recommended an independent review of the program.(7)  In response, CDRH has commissioned an Institute of Medicine (“IOM”) study of the 510(k) program, as well as appointed an internal task force to assess and implement improvements to the program.(8)  The Center has said it plans to implement changes to the program recommended by the task force in as little as a few months, although interactions with the agency on pending 510(k) notices have reflected a general tightening of program policies for at least the past year.(9) 

In addition to the increased attention focused on premarket activities at the device center, CDRH appears to be focused on escalating postmarket compliance activities as well.  In a recent speech, the Director of the CDRH Office of Compliance, Tim Ulatowski, noted that the office is currently targeting firms that have not followed FDA regulations regarding registration of device manufacturing facilities, and will be issuing a batch of warning letters in the coming weeks as part of an intentional enforcement push.(10)  Additionally, in a rare exercise of its postmarket surveillance authority, CDRH has issued an order requiring 12 manufacturers to collect postmarket data on spinal systems cleared through the 510(k) process, due to concerns that there are insufficient data to support marketing of the devices.(11)  Previously, the agency has rarely invoked its authority under the law to mandate these types of studies.(12)

As the new FDA leaders have been in place for less than a year, much remains to be seen regarding the impact of the new leadership on the regulation of the medical device industry.  However, based on recent months, it is apparent that device firms should expect heightened scrutiny and tougher pre- and postmarket regulation for their products.