Regulatory News

21st Century Cures Act Deadlines Approach in March and June

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.

Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) include:

• 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.”
• 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.”

ClinicalTrials.gov

Section 2054 of the Act requires NIH 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.

On Tuesday, several groups of researchers from the Association of Clinical Research Organizations (ACRO), Association of Clinical Research Professionals, Society for Clinical Research Sites and Coalition for Clinical Trials Awareness wrote to NIH officials calling on them “to adhere to this timeline for the benefit of patients everywhere who are awaiting new treatments and cures.”

While recognizing all federal agencies are undergoing a period of transition with the onboarding of new administration officials, the groups also call on NIH and other federal agencies to continue “to improve the functionality, utility and usability of the ClinicalTrials.gov database for the benefit of patients, researchers and other interested parties.”

180 Days

In another three months, or by 13 June, other Cures deadlines have to be met, according to the law’s text, including:

• Under Section 3002, FDA’s commissioner shall develop a plan to issue draft and final guidance documents, over a period of five years, rega
   
  rding the collection of patient experience data, and the use of such data and related information in drug development (though FDA has 18 months to publish a draft guidance on the subject).
• Under Section 404N, called “Population Focused Research,” NIH Director Francis Collins shall convene a workshop of experts on pediatric and older populations to provide input on “appropriate age groups to be included in research studies involving human subjects” and “acceptable justifications for excluding participants from a range of age groups from human subjects research studies.”
• Under Section 3059, Price will identify and publish a list of reusable device types that have been validated with regard to cleaning, disinfection and sterilization.
• Additional patient data protections under Section 2012.