Washington, D.C. – The Senate HELP Committee’s health innovation legislative package is set for a second markup tomorrow. It includes three bills that align with the Bipartisan Policy Center’s recommendations released last summer in its FDA: Advancing Medical Innovation report, co-chaired by former Senate Majority Leader Bill Frist, MD, and former Rep. Bart Gordon.
Over the past year, BPC has been providing technical assistance to the HELP Committee on ways to improve the medical product development process, increase regulatory clarity, strengthen the ability of the U.S. Food and Drug Administration (FDA) to carry out its mission, and increase investment in treatments for unmet and public health needs.
The Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S.1101), introduced by HELP Committee members Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT), contains provisions consistent with BPC’s report that will provide regulatory clarity and ensure that health IT is not regulated as a medical device by the FDA unless determined that the product poses a significant risk to patient safety. Providing such clarity lays the groundwork for a new risk-based framework for health IT that both protects patient safety and promotes innovation.
The Combination Products Innovation Act (S.1767), sponsored by Sens. Johnny Isakson (R-GA), Robert Casey (D-PA), Bill Cassidy (R-LA), Joe Donnelly (D-IN), Mark Kirk (R-IL), Pat Roberts (R-KS), and Pat Toomey (R-PA), contains several provisions included in BPC’s recommendations, that promote greater coordination and agreement among FDA centers, improve the timeliness of response and decision-making, and address the lack of clarity regarding data requirements.
The Patient-Focused Impact Assessment Act (S. 1597), sponsored by Sens. Roger Wicker (R-MS) and Amy Klobuchar (D-MN) also includes provisions in line with BPC’s report that will help ensure that patient perspectives are incorporated into the drug development and approval process.
“This markup by the HELP committee is an important step toward moving forward companion legislation to the House’s 21st Century Cures bill,” said Janet Marchibroda, BPC health innovation director. “Passing medical innovation legislation is critical to accelerating the discovery, development, and delivery of new cures and treatments for patients.”
Janet Marchibroda, BPC health innovation director, is available for comment.
KEYWORDS: FOOD AND DRUG ADMINISTRATION, JOHNNY ISAKSON, ORRIN HATCH, MARK KIRK, PAT TOOMEY, JANET MARCHIBRODA, 114TH CONGRESS, MICHAEL BENNET, AMY KLOBUCHAR, SENATE HELP COMMITTEE, PAT ROBERTS, BOB CASEY, JOE DONNELLY, ROGER WICKER, 21ST CENTURY CURES