While it was signed into law on December 13, 2016, the 21st Century Cures Act does include several provisions that must be implemented by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the National Institutes of Health (NIH) beginning in June.
Here is what to expect this Summer:
- FDA statements on patient experience data. Beginning June 11, the FDA is required to make brief, public statements on whether and how patient experience data was used in the review of a new drug or biologic application. These statements may influence the marketplace’s perceptions of new products.
- Updated human research privacy protections. New protections went into effect on June 11. These new requirements may require biopharmaceutical companies to re-assess their regulatory requirements for clinical trials.
- An increase in FDA activities geared towards innovation. The FDA and NIH developed work plans for implementing funding focused on innovation initiatives. We expect that the work plans will drive regulatory and scientific decision-making for the next several years. The funds will enable the agencies to create future policy, as directed by Cures, related to patient-focused drug development, biomarker qualification, and adaptive trial designs.
- An open comment period for a Cures-required NIH workshop on research for pediatric and older populations. This is an opportunity for stakeholders to provide feedback on standard-setting decisions related to clinical trial inclusion/exclusion criteria, study designs and metrics, and data collection and reporting for subgroups. Comments are due by June 30.
Each of these developments represent opportunities to engage with federal agencies and help shape their policy related to research and development, incorporating the patient perspective into product labels, and ensuring efficient use of federal resources for market access.
For additional information on ways your organization can prepare for and engage in these and upcoming activities, as well as in 21st Century Cures implementation broadly, please contact Nancy Beck or Jay Jackson.