Wednesday, 29 December 2021

• The U.S. Food and Drug Administration (FDA) recently released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs for drug development programs. The draft guidance, “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products,” discusses the investigational new drug (IND) requirements for interventional studies, and recommends early engagement with FDA if non-interventional (observational studies) utilizing RWD are intended to support a marketing application. We have summarized this latest guidance online here. We predict FDA will continue to apply lessons from its RWE efforts, especially those learned during the COVID-19 pandemic, to evolve policies for collecting and submitting RWD/RWE to support applications. (Authored by Lynn Mehler and Lowell Zeta)

• Yesterday, FDA limited the emergency use authorization (EUA) for COVID-19 convalescent plasma to that with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment. On the same day, FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information regarding the impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests. The update includes preliminary study results of some antigen tests using patient samples containing live virus. Early data suggest that antigen tests do detect the omicron variant but may have reduced sensitivity. Last week, FDA had released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies. FDA said data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant. FDA updated the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered together, REGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant. (Authored by Randy Prebula)

• Last Wednesday, the U.S. Food and Drug Administration issued an EUA for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Then on Thursday, FDA issued an EUA for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Also last week, FDA authorized the OTC COVID-19 antigen test SD Biosensor, Inc. COVID-19 At-Home Test, which is the first test where validation data were gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). Then, this week, a U.S. District Court entered a consent decree that temporarily prohibits Natural Solutions Foundation from distributing any drugs, after FDA alleged the company unlawfully sold unapproved and misbranded drugs intended to cure, mitigate, treat or prevent COVID-19. (Authored by Randy Prebula)

Wednesday, 22 December 2021

• On 17 December 2021, the U.S. Court of Appeals for the Sixth Circuit lifted a stay on the Occupational Safety and Health Administration's (OSHA) "vaccination-or-test" Emergency Temporary Standard (ETS), allowing the ETS to take effect. The ETS requires, among other things, that employees of employers with 100 or more employees be fully vaccinated against COVID-19 or tested weekly. Although ETS opponents have asked the U.S. Supreme Court to reinstate the stay while legal challenges proceed before the Sixth Circuit, unless and until the Supreme Court or Sixth Circuit rules otherwise, employers will need to come into compliance with the ETS. Fortunately, OSHA has provided employers with some breathing room on the ETS compliance deadlines, as discussed in greater detail below. Employers that paused their compliance efforts should carefully review the new legal landscape, strongly consider ramping up good faith compliance efforts, and be prepared for further uncertainty as litigation continues. Read more online here. (Authored by George Ingham)

• On 15 December, the U.S. Food and Drug Administration (FDA) approved an abbreviated new drug application (ANDA 211538) for Vasopressin Injection, 20 Units/mL Multiple Dose Vials, indicated to increase blood pressure in adults with vasodilatory shock (sudden relaxation of blood vessels) who remain hypotensive (low blood pressure) despite fluids and catecholamines (a class of neurotransmitters). This is the first approval of an ANDA for this product. FDA remarked in approving it that it recognized the increased demand for certain products during the COVID-19 public health emergency. Then, on 16 December, FDA approved a manufacturing change for Comirnaty (COVID-19 Vaccine, mRNA) to include a formulation that uses a different buffer. Buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers. FDA previously authorized this vaccine formulation for the Pfizer-BioNTech COVID-19 Vaccine in October. (Authored by Randy Prebula)

• On 6 December, New York City announced that beginning 27 December it would require all private employers to require their employees to show proof of COVID-19 vaccination before entering the workplace. Since the announcement, the commissioner of the Department of Health and Mental Hygiene (DOHMH) and the NYC Department of Health have issued an order and subsequent guidance on the specifics of the mandate including who is covered and what obligations are facing employers. We have analyzed these new requirements online here. (Authored by Michael DeLarco)

Wednesday, 15 December 2021

• On 7 December 2021, a U.S. federal district court issued a nationwide preliminary injunction prohibiting the government from enforcing its COVID-19 vaccination mandate for federal contractors while a legal challenge to the mandate is litigated. Following this ruling, there is now a trifecta of nationwide stays of all three federal vaccination mandates applicable to private employers – the federal contractor mandate, the OSHA ETS, and the CMS rule. Employers in the U.S. need to weigh a variety of considerations – including state laws prohibiting or restricting vaccination mandates – to determine whether to press forward with mandatory vaccination policies or to pause while the issues in litigation are resolved. We have analyzed these competing concerns online here. (Authored by William Ferreira and Joy Sturm)

• Last week, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.  FDA also issued an EUA for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms). This week, FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers, which now include a contraindication to the administration of the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine. (Authored by Randy Prebula)

• On 18 November 2021, District of Columbia Mayor Muriel Bowser signed emergency legislation that requires private employers in D.C. to provide eligible employees with paid time off for their own and their children’s COVID-19 vaccinations and recovery from vaccination side effects. The new law also extends the availability of unpaid, job-protected COVID-19 leave under the D.C. Family and Medical Leave Act (DCFMLA) for employees whose employers have 20 or more employees in the District. We have analyzed this new Act online here. (Authored by George Ingham)

Wednesday, 8 December 2021

• On Monday, the U.S. Food and Drug Administration (FDA) updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information, adding new information about FDA recommendations for clinical laboratory staff and health care providers. FDA added information about the Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test, including the impact of the SARS-CoV-2 omicron variant on test performance and the laboratories where the test is performed (it is not believed to be used for high volume testing). FDA updated the list of tests with S-gene drop out; FDA said that since these tests are designed to detect multiple genetic targets, the overall test sensitivity should not be impacted. (Authored by Randy Prebula)

• On the Hill last week, U.S. Rep. Ralph Norman (R-SC) introduced legislation that would require FDA to release all records of information submitted to the agency regarding the authorization of emergency use of, or licensing of all COVID-19 vaccines. Also last week, U.S. President Biden announced his administration’s plans to fight COVID-19 this winter and changes needed due to the omicron variant, saying the U.S. will focus on expanding at-home testing, expanding booster access, and accelerating vaccine donations. Meanwhile, U.S. public health agencies are stepping up COVID-19 monitoring as they plan to wait two to four weeks to discover how much the current vaccines protect against the omicron variant. The U.S. Centers for Medicare & Medicaid Services (CMS) seeks to expand access to individualized medical advice in all communities by requiring states to cover COVID-19 vaccine counseling visits in which health care providers talk to families about the importance of kids’ vaccination. (Authored by Ivan Zapien)

• In the latest episode of our "Thanks... Good Talk" Shortcast titled, “Current developments in politics and the economy,” Ivan Zapien and Mark Irion sit down with Neil Chatterjee, a new member of Hogan Lovell’s Energy Regulatory and Government Relations and Public Affairs practices, to discuss Chatterjee's background and current developments happening in politics and the economy, including the impact of the pandemic on U.S. political races.

• In the latest episode of our Talking the Cure podcast, Christian Di Mauro, who is heading the Italian litigation and arbitration practice at Hogan Lovells, talks about his 17 years of experience in the Life Sciences and Health Care industry, and his work for manufacturers of pharmaceuticals, vaccines, medical devices. He discusses his advice for Italian and French companies as a litigator, his biggest matter, and his approach to work-life balance.

Wednesday, 1 December 2021

• Yesterday, the U.S. Food and Drug Administration issued a statement that it is actively working with federal partners, international regulators, and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic. And in a new project funded by the FDA, Embleema and George Washington University will conduct bioinformatic research and system development to expand the FDA-ARGOS database. FDA-ARGOS contains curated, quality-controlled genomic sequence data to support research and regulatory decisions. For example, researchers can use the FDA-ARGOS along with bioinformatics tools to validate the performance, sensitivity and specificity of diagnostic tests with computer modeling. Building on expansions during the COVID-19 pandemic, this project aims to further improve the utility of the FDA-ARGOS database as a key tool for medical countermeasure development and validation. (Authored by Randy Prebula)

• The COVID-19 pandemic has caused upheaval across labor markets and resulted in what some have termed the “Great Resignation.” In the midst of these challenging labor market conditions, employers should be aware that the Department of Justice Antitrust Division and Federal Trade Commission (FTC) in the U.S. continue to expand their scrutiny of agreements that restrict the solicitation, wages, or movement of employees. It is important to stay up to date on these developments and to understand what circumstances may separate common, lawful business practices from possible antitrust violations. Online here we have analyzed how U.S. antitrust enforcement actions in labor markets continue to evolve in response to the pandemic and other global trends. (Authored by Benjamin Holt)

Compiled by Aaron Armstrong