More Than 40 Lawmakers Urge FDA To Overhaul Device Review Policies- Gray Sheet:
A slew of lawmakers in both chambers are advocating major changes to FDA device reviews, with the group urging the agency to embrace a “least burdensome” approach that involves tracking device approvals in real time, harmonizing requirements with international standards, addressing new conflict-of interest rules and creating a product review tracking system, among other changes. These proposals, many of which are already tucked into pending legislation, are expected to take center stage when Congress considers reauthorizing the device user fee program next year, with lawmakers for months already raising device-related concerns.
These ideas have been included in recent bills or proposals from key lawmakers, including members of the House Energy and Commerce Committee and Senate health panel. Sen. Richard Burr (R-NC), for example, has pushed for FDA review times to include periods when firms are answering agency questions and for the clock not to pause, while Rep. Michael Burgess (R-TX) has drafted legislation to repeal advisory committee conflict of interest rules implemented as part of the last iteration of user fees.
The device industry has long argued that it faces unclear and overly burdensome device review requirements, but recent data suggest that those concerns have merit, according to the lawmakers, who pointed to information demonstrating that 510(k) review times increased 43 percent from the 2003-2007 time period to 2010, with premarket approval times jumping 75 percent.
The lawmakers -- members of the Congressional Medical Technology Caucus -- even leveraged a recent report issued by the Obama administration's Jobs Council outlining the declining investment in life sciences due to increased development costs and risk.
“Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry,” the lawmakers wrote in a letter to FDA Commissioner Margaret Hamburg. “The total review times for both 510(k)s and PMAs are now actually longer than they were before the user fee program was instituted. … Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.”
Signatories of the recent letter include Sens. Dick Lugar (R-IN), Al Franken (D-MN), Amy Klobuchar (D-MI) and Scott Brown (R-MA), and Reps. Anna Eshoo (D-CA), Erik Paulsen (R-MN), Burgess, Michele Bachmann (R-MN) and Jan Inslee (D-WA). In sum, 41 lawmakers signed the letter, which was also sent to HHS Secretary Kathleen Seblius. -- Ben Moscovitch ( bmoscovitch@iwpnews.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it )
