FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency

April 23, 2020 Alerts and Newsletters

On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and answers to the guidance’s appendix. To learn more about the FDA’s guidance, please see our prior alerts here and here.

The guidance’s latest questions and answers tackle the following issues:

  • Obtaining informed consent remotely, when electronic consent in not an option, including through the use of fax, email, and telephone. FDA’s prior guidance addressed obtaining informed consent for participants in COVID-19 isolation.
  • Determining whether to implement remote performance outcome (PerfO) assessments and/or interview-based clinician-reported outcome (ClinRO) assessments, including considerations for minimizing variability, ensuring accuracy and reliability, ensuring feasibility for subjects with disabilities, protecting subject safety and privacy, and providing technical support to facilitate assessments.
  • Conducting site monitoring visits, including source document review, remotely, including considerations for prioritizing sites for remote monitoring as well as remote document access options such as establishing a secure remote viewing portal, obtaining remote access to electronic health records, or uploading certified copies of source records to a sponsor-controlled electronic system or other cloud-based repository that contains appropriate security controls.
  • Obtaining a short-term waiver from electronic common technical document (eCTD) requirements.
  • Shipping investigational products to locations other than clinical trial sites (for example, local health care providers who are not sub-investigators), including appropriate documentation and required approvals. This topic was addressed more generally in FDA’s prior guidance.
  • Local sourcing by clinical trial subjects or health care providers of investigational products that are FDA-approved for other uses, including compliance with investigational new drug (IND) regulations regarding charging for an investigational drug and labeling.
  • Consulting with FDA review divisions on COVID-19 issues for drug and device clinical trials.

This updated guidance shows FDA’s efforts to respond in a timely manner to operational and logistical issues faced by researchers, institutional review boards, and clinical trial sponsors navigating these unprecedented times. We expect FDA will continue to update its question-and-answer appendix as it continues to engage with the research community on these topics.

As noted in our separate alert on the U.S. Department of Health & Human Services Office for Human Research Protections (“OHRP”) guidance from April 8, 2020, OHRP has endorsed FDA’s guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” as consistent with the requirements of the Common Rule (the regulations applicable to research conducted, supported, or otherwise subject to regulation by 20 federal agencies, including the U.S. Department of Health and Human Services). However, it is unclear how questions and answers added to the appendix of FDA’s guidance after the issuance of OHRP’s endorsement will be treated.

For questions, please contact Sarah V. Ferranti, Emily Chi Fogler, Kate Gallin Heffernan, Andrew P. Rusczek, or your regular Verrill attorney.

Firm Highlights

News

65 Verrill Attorneys Recognized by Best Lawyers® 2022, Including Eight Named Lawyers of the Year

(August 31, 2021) – 65 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2022 , including 8 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer in...

Publication/Podcast

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...

Publication/Podcast

Hospital Price Transparency Rule: Full Steam Ahead

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services ( CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should...

Publication/Podcast

340B Providers Get Partial Relief from New Dispute Resolution Regulation

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...

Publication/Podcast

Massachusetts Health Care Bill Makes Several Significant Changes

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...

Publication/Podcast

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...

Publication/Podcast

Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.

Health care attorney Paul Shaw co-authored Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition with Robert Griffith, published by the American Health Law Association (AHLA). Paul and Robert provide legal...

Publication/Podcast

“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments

News

Verrill Welcomes Jeffrey A. Smagula, Experienced Health Care and Life Sciences Attorney, Former Health Plan Compliance Executive

(May 12, 2021) – Verrill is pleased to welcome Jeffrey A. Smagula to the firm’s Boston office as Counsel in its nationally recognized Health Care & Life Sciences Group. Jeff Smagula brings to Verrill...

Contact Verrill at (855) 307 0700