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

Hogan Lovells

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 warns over drug misbranded as COVID-19 treatment; podcast discusses Trump's "Buy American" executive order; an op-ed on the importance of protecting biomedical innovation; HHS sees high level departures; and U.S. negotiations over a testing strategy and relief bill stall.

Tuesday, 27 October 2020

  • Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These letters, to Nalpropion and Nephron, rebuke drug sponsors for failing to communicate safety risk information. And, the Nephron letter cites emails that claim budesonide can treat COVID-19 symptoms, which is notable because it is one of the first OPDP warning letters in recent years to cite promotion of an unapproved use. Read more here. (Authored by Meredith Manning and Heidi Gertner)

  • In the midst of a global pandemic, the biopharmaceutical industry’s pivotal role in developing vaccines and therapies to combat COVID-19 and restart the economy is readily apparent. Yet skeptics remain, and recent proposals to severely cut prices threaten to limit future biomedical innovation long after the pandemic has run its course. We understand that some patients cannot afford to pay the full cost (or even the copay) of some medicines, and that we must take steps to ensure universal access to essential therapies. But to do so by arbitrarily linking prices to those established by overseas governments risks losing yet-to-be-developed therapies that will address tomorrow’s unmet medical needs. Read more here. (Authored by John E. Osborn)

  • 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. In a letter to colleagues on Monday, House Speaker Nancy Pelosi (D-CA) said the White House has refused to sign on to Democratic lawmakers’ plan for a coronavirus testing strategy, despite earlier public statements to the contrary by Treasury Secretary Steve Mnuchin. Pelosi’s letter to House Democrats came only minutes before a planned conversation with Treasury Secretary Steven Mnuchin as the two push to reach a stimulus agreement. The chances of Congress approving a relief bill before Election Day have all but evaporated. At least five of Vice President Mike Pence’s staff, including chief of staff Marc Short, have tested positive for coronavirus. The Vice President has tested negative so far. The Department of Health and Human Services (HHS) continues to see an alarming number of high-level departures; POLITICO reports that at least 27 top political appointees have left the department since the COVID-19 pandemic, and more officials are expected to depart this week, including Danielle Steele, a top adviser to Secretary Alex Azar on FDA and National Institutes of Health. On 25 Oct., White House Chief of Staff Mark Meadows told CNN’s Jake Tapper that the U.S. was “not going to control the pandemic” but instead “control the fact that we get vaccines, therapeutics and other mitigation areas.” On Monday, Meadows defended his remarks saying that the “full context” of his comments referred to the “need to make sure that we have therapeutics and vaccines” to treat COVID-19. Read about these and other updates here: 22 Oct.; 23 Oct.; and 26 Oct. (Authored by Ivan Zapien)

  • Our "Talking the Cure" podcast analyzes cutting-edge topics including COVID-19, digital health, clinical trials, supply chain, Brexit, and more. In a new episode, we discuss the Trump Administration's "Buy American" Executive Order, which is aimed at shoring up domestic manufacture of "essential medicines", "medical countermeasures", and "critical inputs" (API and other raw materials), and decreasing dependency on non-domestic sources. Philip Katz leads a discussion with Joy Sturm, Mike Heyl, Kelly Ann Shaw, and David Horowitz about what they're seeing, what they expect, and what actions companies are – or should be – taking or considering.

[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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