Some may say that Congress will remain frustratingly gridlocked with campaign politics now in full force. Yet patients, clinicians, researchers, and industry professionals should be pleased to know that the Senate Health, Education, Labor and Pensions (HELP) Committee continues its hard work of more than a year to pursue bipartisan legislation to improve the discovery-development-delivery cycle for innovative drugs and medical devices. The House passed its 21st Century Cures legislation last summer after a 15-month long process.
These efforts are not only bipartisan and productive; they also address critical needs for the country. It can take more than ten years and $2 billion for a new treatment to reach the market. Patients, providers, innovators, and policymakers have rightly asked whether there is a better way: a process that modernizes the regulatory system to account for treatments that don’t squarely fit into the old regulatory regime; accounts for better data from real-world clinical and patient experience; improves the use of health information technology to improve health and the quality, efficiency, and experience of health care delivery; and appropriately balances the need to assure safety and efficacy with the desire for faster approval of treatments for patients with serious, rare, or life-threatening diseases or other unmet needs.
In concert with congressional efforts, the Bipartisan Policy Center launched FDA: Advancing Medical Innovation, co-chaired by former Senate Majority Leader Bill Frist, MD and former Rep. Bart Gordon, which published an extensive set of policy recommendations in its July 2015 report. Since then, BPC has provided technical assistance to the committee and its members as they craft and refine medical innovation legislation. At HELP Committee Chairman Lamar Alexander’s request, BPC honed in on ten priority areas that could be accomplished in the near term:
- Strengthen the U.S. Food and Drug Administration.
- Advance precision medicine.
- Allow manufacturers to share certain scientific information with doctors on “off-label” use of approved medical products.
- Improve combination product regulation.
- Develop a regulatory framework for regenerative cellular therapy.
- Improve regulatory clarity for health information technology.
- Utilize real-world evidence for pre- and post-market activities.
- Expand use of drug development tools: biomarkers and patient-reported outcomes.
- Improve interoperability of health information technology.
- Integrate patient perspectives into benefit-risk framework.
Progress in these areas, and others that may simply be outside the scope of BPC’s report, is encouraging. For example, among the nine bills that passed with bipartisan support in the HELP Committee’s February 9 markup was the Improving Health Information Technology Act (S. 2511). This bill would significantly bolster the use and interoperability of health IT to improve care. Bills scheduled for mark-up on March 9 that align with BPC recommendations include the Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101), introduced by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT)) and the Combination Products Innovation Act of 2015 (S.1767), introduced by Sens. Johnny Isakson (R-GA), Bob Casey (D-PA), Joe Donnelly (D-IN), and Pat Roberts (R-KS).
BPC looks forward to continuing our work with policymakers to advance bipartisan legislation to improve medical innovation. The time is now. The will is there. Small steps to change are within reach.
KEYWORDS: FOOD AND DRUG ADMINISTRATION, BILL FRIST, JOHNNY ISAKSON, ORRIN HATCH, LAMAR ALEXANDER, 114TH CONGRESS, MICHAEL BENNET, BART GORDON, SENATE HELP COMMITTEE, PAT ROBERTS, HEALTH INTEROPERABILITY, BOB CASEY, JOE DONNELLY