The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
In Tuesday's Report: FDA proposes clarification on "intended use" rules, revokes May 2020 umbrella EUA for infusion pumps, and previews forthcoming guidance on post-pandemic EUAs; Luxembourg promotes virtual meetings; Trump administration plans to deploy 150 million rapid tests, and other U.S. governmental updates.
Tuesday, 29 September 2020
On 23 September, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical device, drug, or combination product. The proposed rule’s preamble says that certain types of evidence, standing alone, are not dispositive of intended use, while reserving the ability to look to other relevant sources of evidence that might inform a product’s intended use. This is consistent with FDA’s longstanding practice and with the agency’s January 2017 final rule, which we summarized here. FDA delayed the effective date of that final rule due to concerns expressed by industry stakeholders over the regulation’s requirements around whether a manufacturer is required to update labeling if it has knowledge of unapproved, or “off label” use, leaving in effect text indicating that such knowledge does trigger this manufacturer responsibility. Read more here. (Authored by Susan Lee, Meredith Manning, and Jodi Scott).
On 21 September, FDA announced the revocation of its May 2020 umbrella emergency use authorization (EUA) for infusion pumps and infusion pump accessories, which it had granted for use by health care providers (HCPs) to treat conditions caused by COVID-19 with the controlled infusion of medications, total parenteral nutrition (TPN), and/or other fluids. This umbrella EUA had included infusion pumps with remote monitoring, remote manual control features, or administration sets with increased length to reduce HCP exposure and to help maintain a safe physical distance between HCPs and patients with confirmed or suspected COVID-19. To date, no devices have been placed under this umbrella EUA. Now, FDA says that, based on information and experience since issuance of the umbrella EUA, circumstances support revocation of the umbrella EUA to protect the public health and safety. Instead, FDA may issue individual EUAs for infusion pumps and infusion pump accessories that meet the requisite statutory criteria. FDA stated that individualized EUAs for these devices will allow for: a) tailored indications and scopes of authorization, including those for different environments of use, routes of administration, and patient populations; b) specific conditions of authorization to address any issues unique to a particular device; and c) streamlined EUA amendments, including additional uses that would not have been encompassed by the umbrella EUA. (Authored by Christine Zimmerman and Lina Kontos)
Speaking at the Regulatory Affairs Professionals Society (RAPS) Convergence 2020 conference, Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said FDA is drafting a guidance document that will offer industry recommendations on how to handle products granted emergency use authorization (EUA) during the COVID-19 pandemic, after the public health emergency ends. Shuren said the guidance would focus on two types of products: 1) medical devices currently under an EUA for which full marketing authorization will be sought; and 2) products that now have full marketing authorization, but that have been modified under temporary COVID-19-related enforcement discretion policies. Regarding CDRH’s goals with the forthcoming guidance, Shuren remarked, “[W]e’re not anticipating any big changes anytime soon, but we also think it’s a good time to at least get feedback on what an appropriate approach to transition should look like.” (Authored by Randy Prebula)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. President Trump announced Monday a plan to deploy 150 million rapid tests to states and vulnerable communities. Dr. Deborah Birx is not the only person on the White House coronavirus task force to question the task force’s newest member, Dr. Scott Atlas; Centers for Disease Control and Prevention (CDC) Director Robert Redford told a colleague during a 25 Sept. phone call that “everything” Dr. Atlas says “is false.” Redfield warned his colleague that Atlas was misleading President Trump with everything from mask efficacy to herd immunity. The CDC now projects between 214,000 to 226,000 COVID-19 deaths in the U.S. by 17 October. The National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) warn that political interference has pervaded the U.S. government’s scientific and public health workers responding to the coronavirus response. Read about these and other updates online here. (Authored by Ivan Zapien)
As the COVID-19 pandemic is still disrupting businesses in continental Europe, including the Grand Duchy of Luxembourg, the Luxembourg government continues to encourage social distancing and home-office whenever possible. In this context, the Luxembourg parliament adopted a new law on 23 September 2020 to extend the measures allowing virtual meetings until 31 December 2020. The law of 20 June 2020 extended the measures concerning the holding of meetings in companies and other certain legal persons without the physical presence of the participants, initially provided for in the Grand Ducal Regulation of 20 March 2020. Read more here. (Authored by Gerard Neiens)