Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement on today’s hearing in the House Energy and Commerce Health Subcommittee on implementation of the FDA Safety and Innovation Act (FDASIA), which included language reauthorizing the medical device user fee program:
“AdvaMed would like to thank Subcommittee Chairman Joe Pitts (R-PA), Ranking Member Frank Pallone, Jr. (D-NJ) and the other members of the Subcommittee for holding today’s hearing. We appreciate their continued focus on making sure that FDA is properly resourced and that the agency is on track to meet its commitments under the law. Congress is an essential partner in the effective implementation of FDASIA, and we appreciate the Subcommittee’s engagement with industry and FDA moving forward.
“FDASIA reauthorized the medical device user fee program with an agreement designed to improve the efficiency, predictability and accountability of the agency’s review process. This agreement coupled with other device-related provisions of FDASIA is intended to ensure American patients have timely access to the latest advances in medical technology and maintain U.S. global competitiveness in medical innovation.
“The legislation received near-unanimous votes in both the House and Senate, underscoring the strong bipartisan support for FDASIA’s approach to improving the agency’s performance. While it is too soon to say whether the user fee agreement and other reforms are working, the initial, limited quantitative data provided by FDA is encouraging. However, there are a number of progress points that still have to be met, and we encourage FDA to make every effort to meet all the commitments they made under FDASIA.
“AdvaMed commends the FDA and CDRH leadership for their efforts in implementing FDASIA so far. They have given every indication they are serious about meeting the performance goals specified in the user fee agreement and are committed to collaborating with industry and working to improve the transparency and responsiveness of the agency.
“Unfortunately, because of the sequester, FDA’s device center has already lost $2.9 million in industry user fees this year and will lose more in coming years if this situation is not addressed. AdvaMed believes user fees paid by industry to FDA should not be treated the same way as taxpayer dollars, and we urge all members of Congress to support the bipartisan legislation introduced in both chambers to exempt all FDA user fees from the sequester.”