COVID-19 Expanded Access Template

March 19, 2020 Alerts and Newsletters

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements are not required to be and are not always documented in written agreements, there can be benefits to both parties (company and treatment provider) to memorializing the circumstances of the provision of an investigational drug.

To that end, we have created a simple Memorandum of Understanding template that may be useful to companies and providers seeking to document these arrangements quickly and efficiently in light of the current public health emergency. The template is intentionally streamlined and balanced, to capture the common denominator of terms that are often included in these agreements in a way that is reasonable for both parties. The template is drafted to focus on the provision of investigational drugs, as we understand drugs to be the primary expanded access treatment option at this stage of the pandemic. To the extent there is a demand for the expanded access use of investigational devices, this template can be modified (or we can tailor and re-circulate a device version). The template is also focused on the requirements for expanded access under the FDA’s regulations (21 C.F.R. § 312.300 et seq.) and would require modification for the provision of investigational drugs pursuant to the federal Right to Try Act.

Please note that this template is not intended as legal advice, and our circulation of this resource does not create an attorney-client relationship. We merely want to make as many tools available to the regulated community as we can during these challenging times.

Click here to download the Memorandum of Understanding template.

Firm Highlights

Matter

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...

Publication/Podcast

Responsible Research During the COVID-19 Pandemic

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Matter

Research Non-Compliance Investigations

Test Tubes
Matter

On-Site Counsel

Provided coverage to in-house research counsel and the research compliance department at various institutions during times of staffing transitions, working hand-in-hand with the client to manage daily legal needs related to research compliance.

Matter

Research Misconduct

Represented various hospital systems in connection with research misconduct investigations, including advising on the internal investigation, assisting with the drafting of required reports, and communicating with federal regulators and respondents' legal counsel.

Matter

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

Matter

Institutional Review Board

Assisted a prominent university with the development of a NIH-funded national IRB reliance model in facilitation of NIH's Single IRB Review Policy.

Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

Publication/Podcast

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to...