Thursday, 5 November 2020

• On 3 November 2020, the U.S. Food and Drug Administration (FDA) issued a letter to clinical laboratory staff and health care providers (HCPs) alerting them of the potential for false positive results from antigen tests used for the rapid detection of SARS-CoV-2. FDA warned that when users do not properly follow the manufacturer's instructions for use (IFU) for these rapid detection COVID-19 antigen tests, false positive results can occur. FDA provided several recommendations and considerations for clinical laboratories and HCPs, which included, but was not limited to, the following: Follow the manufacturer's IFU when performing the testing and reading test results; Reading test results before or after the specified time could result in false positive or false negative results; Processing multiple specimens in batch mode may make it more challenging to incubate each specimen for the correct amount of time; Be careful to minimize risks of cross-contamination; Remember that positive predictive value (PPV) varies with disease prevalence when interpreting diagnostic test results (i.e., as disease prevalence decreases, the percent of false positives increases); Consider positive results in combination with clinical observations, patient history, and epidemiological information; Consider patient specific factors, such as the presence of human antibodies (e.g., Rheumatoid Factor, or other non-specific antibodies) or highly viscous specimens. FDA also stated that antigen testing is an important tool with respect to the overall response to COVID-19. Although antigen tests are historically not as sensitive as molecular tests, one of their main advantages is their ability to provide test results in a matter of minutes. FDA indicated that antigen tests may provide the ability to test millions of Americans for SARS-CoV-2 very rapidly. FDA indicated that it continues to work with test manufacturers to ensure that their test IFUs are as clear as possible to reduce the occurrence of false results. (Authored by Seth Olson)

• 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) outlined a busy lame-duck agenda Wednesday, saying he wants another coronavirus relief bill by the end of the year and a government spending bill by the December 11 government funding deadline. Four in 10 voters named the COVID-19 pandemic as their top issue in the presidential race, according to the Associated Press VoteCast. Voters were more likely to say that the government should focus on limiting the spread of the virus, even if it damages the economy, than to say the economy should be prioritized above all else. Litigation over the COVID-19-prompted surge in mail-in balloting continues post-election. The U.S. Postal Service (USPS) said Wednesday that it completed court-ordered sweeps of postal facilities for over 300,000 ballots late Tuesday. But the Service admitted to missing the 3 pm Tuesday deadline to do so. As coronavirus cases continue to surge across the U.S., many of the hardest-hit states are declining to take action to slow the spread, the New York Times reports. Governors, particularly Republicans, are resisting many types of recommended restrictions. Read about these and other updates here: 2 Nov. & 4 Nov. (Authored by Ivan Zapien)

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)

Compiled by Aaron Armstrong