Bipartisan caucus calls for faster medical device reviews

The bipartisan, bicameral Congressional Medical Technology Caucus raised concerns over the FDA’s medical device approval process in a letter sent to the agency early this month. The legislators suggested that slow approval times for medical devices may lead to the displacement of the U.S. as the leader in developing medical technology. They also stated that the industry indirectly creates two million American jobs.

Addressed to FDA Commissioner Margaret Hamburg, the letter calls for several changes to the FDA approval process, including rectifying slow approvals, considering harmonization with international testing standards, addressing problems associated with conflict of interest rules for advisory panels and creating a clear tracking and review system.

“This is an industry that has become increasingly important as dramatic improvements over the last decade have revolutionized healthcare and improved the quality of life for millions of Americans,” wrote Reps. Anna G. Eshoo (D-Calif.) and Erik Paulsen (R-Minn.) along with Sens. Amy Klobuchar (D-Minn.) and Scott P. Brown (R-Mass.) as well as 37 other legislators. “We share your commitment to ensuring safe and effective medical devices are available to patients. However, we are very concerned about recent declines in FDA performance. Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry.”

The letter also referenced the President’s Jobs Council report this month, which shared some of the concerns.

Authors noted an increase in approval time for 510(k) applications of 43 percent from the 2003-2007 period to 2010, as well as an increase of 75 percent to approve a PMA application. In addition to time constraints, the cost to get new products approved has also increased substantially, according to the authors. “Companies spend an additional $520,000 a month as they wait for FDA approval of a 510(k) product and $740,000 each month for a PMA product. This is simply unsustainable.”

Click here to view the letter.