COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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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: U.S. GOP unveils relief proposal; FDA increases use of virtual tools & optimizes inspectional activities; Biden to fund mass production of OTC test; and an analysis of how blockchain could help supply chain issues.

Tuesday, 2 February 2021

  • The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has been forced to pilot new inspectional initiatives, including increased use of records requests under 21 USC 374(a)(4) and increased reliance other health authorities’ inspections under the Mutual Reliance Initiative (MRI). FDA has published a summary report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative, which is aimed at strengthening FDA’s ongoing COVID-19 response and building the agency’s resilience to respond to future emergencies, including by identifying several “broad cross-cutting ‘Action Areas’ that reflect ongoing and potential prospective actions.” Notably, these action areas include “continu[ing] to evolve and optimize inspectional operations, building on the COVID-19 experience as a catalyst” and “strengthen[ing] supply chain surveillance for regulated products,” suggesting that several of FDA’s COVID-related inspection pilot projects will continue into the future. Read more online here. (Authored by Jim Johnson)

  • 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. A group of 10 GOP senators unveiled an estimated $618 billion coronavirus relief proposal on Monday ahead of a meeting with President Biden to discuss relief legislation. Monday evening, Senator Susan Collins (R-ME) and the Republican Senators emerged from the longer-than-expected meeting, saying there was a "good exchange of views" as they discussed the differences between the packages. Collins said they didn't come together on a single package but did agree to follow up at the staff level as they work further among themselves and with President Biden and Vice President Harris on a COVID-19 relief package. The nonpartisan Congressional Budget Office (CBO) projects that the U.S. economy will return to its pre-pandemic size by mid-2021. The Biden Administration is funding the mass production of a rapid, over-the-counter COVID-19 test. A top FDA official said Friday that the agency will try to have a "streamlined" FDA process for authorizing any updates required for COVID-19 vaccines to adapt to the threat of new variants. Johnson & Johnson announced that results from its clinical trials show that it provides strong protection against COVID-19. Read about these developments here: 28 Jan.; 29 Jan.; and 1 Feb. (Authored by Ivan Zapien)

  • This month has seen the rollout of the Oxford/AstraZeneca COVID-19 vaccine in the UK and Prime Minister, Boris Johnson, forecasts that "tens of millions" of COVID-19 vaccinations will be administered over the next three months. But how can such a large-scale rapid rollout of vaccines be accurately monitored, and effectively delivered, especially when a program like that is completely unprecedented? Online here IPMT Associate Hannah Schofield explores how Blockchain could have helped with supply chain issues.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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