The 21st Century Cures Act passed with resounding bipartisan support in the final days of President Barack Obama’s second term. The bill, which includes initiatives impacting several federal organizations and the clinical research ecosystem, will be implemented over the next several years primarily by the US Food and Drug Administration (FDA) and National Institutes of Health (NIH). The Regulatory Affairs Professionals Society (RAPS) recently reported, some provisions of the bill must be implemented in the next two weeks.
March 13, 2017 marks 90 days since the law’s passing and subsequently includes some required actions. The RAPS article points out some of the upcoming deadlines:
- “Tom Price, the new Secretary of Health and Human Services, shall establish a task force, called the “Taskforce on Research Specific to Pregnant Women and Lactating Women” to provide guidance on “gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities.”1
- Price also must publish a notice in the Federal Register containing a list of each type of Class II device that no longer requires a report “to provide reasonable assurance of safety and effectiveness.”1
- Another portion of the bill requires NIH officials to “consult with stakeholders, including FDA and the Office of the National Coordinator for Health Information Technology, as well as patients, researchers, physicians, industry representatives, and developers of health information technology to receive recommendations to further enhance ClinicalTrials.gov.”2
These deadlines undoubtedly arrive during a time of change for the FDA and NIH, yet the Cures act was passed with the intention of improving patient care, expanding clinical research programs in the United States, and finding a cure for cancer by the year 2020. With more deadlines approaching at the 180-day mark, or June 13, the new administration officials entering the impacted agencies must come together and work quickly to support the goals of the bill.
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