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Yesterday, the U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges presented by the COVID-19 pandemic. However, in its announcement, FDA emphasized that this policy for IND and premarket approval requirements does not apply to products that have been associated with reported safety concerns or have the potential to cause significant safety concerns to patients. This “grace period” for HCT/P sponsors now ends on 31 May 2021. Read more here. (Authored by Mike Druckman)
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On 18 July 2020, the FDA reissued an emergency use authorization (EUA) to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test (initially authorized for individual samples) for use with pooled samples containing up to 4 individual swab specimens. Sample pooling is efficient in areas with a low prevalence, where most results are anticipated to be negative. It is expected that by pooling samples less resources will be used, fewer tests will be run, and patients will receive their results much faster. Sample pooling can be used with samples collected by both health care providers and patient self-collected samples and this testing strategy will be important as large portions of the population begin to be tested. Although there is concern that combining samples makes it more difficult to detect positives, validation data for this EUA demonstrated that all pooled samples containing a positive sample were correctly identified. FDA has also updated its FAQs on Testing for SARS-CoV-2 with templates and recommendations for developers on how to validate a test with sample pooling. Finally, FDA is providing regulatory flexibility for developers that offer validated diagnostic tests, including for use with sample pooling, while developers pursue an EUA. (Authored by Christine Zimmerman)
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FDA announced on 16 July 2020 that the agency would close its COVID-19 industry hotline on 17 July, at 8:00 p.m. EST. Given FDA’s recent public statements about EUA priorities and workloads, and the existence of alternate FDA pathways for supporting industry, this change appears to be aimed at streamlining information sharing and reducing redundancies. Moving forward, to meet the ongoing needs related to COVID-19, FDA will continue provide support to address questions regarding COVID-19 and medical devices through an extensive directory of email contacts for topics related to the following: EUAs; device availability; enforcement policies; imports; manufacturing; and fraudulent products. FDA’s directory of COVID-19 related contacts for medical devices can be found on FDA’s website. The COVID-19 industry may also still contact the Agency at its normal information hotline at 1-888-INFO-FDA. (Authored by Seth Olson)
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The Virginia Safety and Health Codes Board on 15 July 2020 adopted the United States' first workplace safety standards designed to establish requirements for employers to control, prevent, and mitigate the spread of COVID-19. At this time, the text of the Emergency Temporary Standard (ETS) has not been finalized; however, it will take effect immediately upon final publication, which is expected sometime during the week of 27 July 2020. These standards will be enforceable by the Virginia Department of Labor and Industry's Occupational Safety and Health Program (VOSH), which can inspect workplaces and impose financial penalties for violation, including up to US$130,463 for each willful or repeated violation (with smaller penalties for lesser violations), as well as criminal penalties in certain circumstances. Read more here. (Authored by George W. Ingham)
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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. Congress returns from recess sprinting to get several must-pass bills, including another coronavirus relief package, passed before they head out for the August recess and don’t return until 8 September. Senate Majority Leader Mitch McConnell (R-KY) is expected to reveal the Republican’s Phase Four coronavirus package this week to begin negotiations. President Trump is demanding that the package include a payroll tax cut while Senate Majority Leader Mitch McConnell (R-KY) insists that the Senate will not pass the next package without liability protections concerning COVID-19. Five companies working to develop a coronavirus vaccine are set to appear before a House subcommittee to discuss their work in creating inoculations. Officials from five companies developing potential COVID-19 vaccine will testify before the House Committee of Energy and Commerce on 21 July. The House Education and Labor Committee says the White House refused to allow the CDC to testify at a hearing next week on reopening schools. President Trump says he'll resume regular coronavirus briefings starting Tuesday as the country experiences a resurgence of cases. Read about these and other updates online here. (Authored by Ivan Zapien)
