Sec. 5. Public meeting on clinical trial flexibilities initiated in response to COVID–19 pandemic

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Not later than 180 days after the date on which the COVID–19 emergency period ends, the Secretary of Health and Human Services shall convene a public meeting to discuss the regulatory flexibilities adopted by the Food and Drug Administration during the COVID–19 emergency period to mitigate disruption of clinical studies and clinical trials, including flexibilities detailed in the March 2020 guidance entitled Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards , and any subsequent updates to such guidance.

The Secretary shall invite to such meeting representatives from the pharmaceutical and medical device industries who sponsored clinical trials and clinical studies during the COVID–19 emergency period and organizations representing patients. Not later than 90 days after the date on which the public meeting under subsection

(a)is convened, the Secretary shall make available on the public website of the Food and Drug Administration a report on the topics discussed at such meeting. Such topics shall include discussion of— the actions drug sponsors took to utilize such regulatory flexibilities and the frequency at which such flexibilities were employed; the characteristics of the sponsors, trials, and patient populations impacted by such regulatory flexibilities; a consideration of how regulatory flexibilities to mitigate disruption of clinical trials during the COVID–19 emergency period, including decentralized clinical trials, may have affected access to clinical studies and trials for certain patient populations, especially unrepresented racial and ethnic minorities; and recommendations for incorporating certain clinical trial disruption mitigation flexibilities into current or additional guidance to improve clinical trial access and enrollment of diverse patient populations. In this section, the term COVID–19 emergency period has the meaning given the term emergency period in section 1135(g)(1)(B) of the Social Security Act ( 42 U.S.C. 1320b–5(g)(1)(B) ).

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42 USC 1320b–5(g)(1)(B)

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Sec. 5

Public meeting on clinical trial flexibilities initiated in response to COVID–19 pandemic

Cite42 USC 1320b–5(g)(1)(B)

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