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 lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House news.
Tuesday, 3 November 2020
Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced today that it published a list of 223 drug and biological product essential medicines and medical countermeasures, as well as 96 device medical countermeasures; the list is online here. FDA also published its criteria for inclusion in the list, and seeks public comment on these criteria and on the list itself. One important consequence of the EO is that, if implemented, the U.S. government will be permitted to buy drugs and medical devices (within the categories included on the lists) that are made in China and India. Purchases of drug products from these countries largely have been restricted, as these countries are considered ineligible “nondesignated countries.” Read more here. (Authored by Joy Sturm)
FDA updated their March 2020 (revised in June) guidance “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” to add gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the COVID-19 pandemic – will not require a new premarket notification to be marketed for remote monitoring. The guidance so far only applies to legally marketed non-invasive remote monitoring devices that measure or detect common physiological data, and the products listed can be connected via Bluetooth, Wi-Fi and other means to share patient data with health care providers. (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. According to Politico, President Trump and his top aides are planning a huge Cabinet overhaul if he wins a second term. Many of those that he is looking to replace are key health-related officials who he views as “disloyal, slow-acting or naysayers” including those who “take a different, more strict tact on the coronavirus response. The White House has moved its election party from the Trump International Hotel on Tuesday night to the White House, according to spokeswoman Kayleigh McEnany on Monday. The CDC recommendations for isolation and quarantine do not preclude Americans from voting in the election, a CDC spokesperson said on Monday. World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus announced late last night that he is self-quarantining after he came into contact with someone who had tested positive for the virus, although he added that he was symptom-free and feeling well. Read about these and other updates here: 29 Oct.; 30 Oct.; and 2 Nov. (Authored by Ivan Zapien)
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