Three former FDA commissioners are calling on Congress to fully fund the agency’s $60 million fiscal year 2020 budget for using more real-world evidence to evaluate drugs, biologics and devices.
Most of that money — $23 million — is earmarked for medical devices. The document is titled “Expanding the Use of RealWorld Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics.” Published this week by the Bipartisan Policy Center, Dr. Robert Califf, Dr. Andrew von Eschenbach and Dr. Mark McClellan also said:
- The FDA should develop timely guidance for using real-world evidence to evaluate new and existing drugs for new indications, and support post-approval study requirements (FDA).
- The FDA should work with the Centers for Medicare and Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC) and others to access real-world data to support regulatory evaluation and value-based payment decision-making.
- The Department of Health and Human Services should make mortality information more accurate, timely and available for research and other population health improvement purposes.
- Relevant government agencies, including the FDA, should adopt a new standard to improve the reliability and relevance of patient data.
- To support the use of real-world evidence during medical product development, the FDA should use artificial intelligence, and run pilot programs using electronic health records, registries, wearables and other mobile technologies.
The former commissioners also called for CMS to hire more employees to evaluate new therapies, and for the FDA and CMS to work more closely together to develop evidence for “potentially high-impact, high-cost medical products.”
The two agencies already collaborate on a parallel medical device review program for Class III devices begun in 2016. The FDA budget for FY 2020 calls for strengthening that program to streamline Medicare coverage for those devices.
“Greater collaboration between the FDA and CMS can foster more efficient total life-cycle evidence development for medical products,” the former FDA commissioners said. “Significant time lags can occur between FDA approval and CMS coverage, given that patient populations covered by large national payers like CMS are often not well-represented within clinical studies conducted for regulatory evaluation. As a result, strong evidence that a medical product is ‘reasonable and necessary’ within that population (per CMS’ statutory mandate) is substantially lacking.”