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 rule requiring annual Right to Try summaries; CDC updates return-to-work guidance; U.S. Senators introduce the HEALS Act, and other Congressional moves.
Tuesday, 28 July 2020
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On 23 July, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an annual summary of such use to FDA. The agency invites public comment on several aspects of the proposed rule, including who should be required to report, and whether this information should be submitted separately from annual IND reports. Read more here. (Authored by Robert Church)
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The U.S. Centers for Disease Control and Prevention (CDC) recently released updated its guidance on the criteria for determining when a worker diagnosed with COVID-19 may return to work. The interim guidance, Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (20 July 2020), is focused on when individuals diagnosed with COVID-19 may end home isolation. It is also incorporated into CDC’s guidance for food companies managing return-to-work requirements for employees and contractors. Read more here. (Authored by Elizabeth Fawell)
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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. Senate Majority Leader Mitch McConnell (R-KY) introduced the “Health, Economic Assistance, Liability Protection, and Schools Act” (HEALS Act). The Republican proposal includes several provisions designed to get children back to school, workers back to work, and winning the health care fight against the virus, McConnell said. Details have yet to be released, but the proposal’s temporary extension that would cut unemployment benefits from $600-a-week to $200 has already been rejected by Democrats and sent all parties to start negotiations as early as early as Monday evening. The Trump administration will invest another US$472 million into expanding Moderna’s Phase 3 clinical trial to test the safety and efficacy of its coronavirus vaccine candidate that started on Monday. President Trump signed four executive orders aimed at lowering the high cost of prescription drugs in the U.S. The orders, which are subject to the regulatory review process, are designed to bring U.S. drug prices at least on par with their costs overseas. Former FDA commissioner Dr. Scott Gottlieb said the U.S. could see upwards of 300,000 deaths from COVID-19 if the country doesn't change its trajectory.
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