Wednesday, 23 February 2022

• Yesterday, the U.S. Food and Drug Administration (FDA) hosted a webinar on its draft guidances on transition plans for COVID-19 related medical devices, which we previously summarized online here. FDA’s CDRH is holding a virtual town hall today to help answer technical questions about the development and validation of tests for SARS-CoV-2. Also yesterday, FDA posted a new resource, the “At-Home OTC COVID-19 Diagnostic Tests” web page, which provides a list of all FDA-authorized at-home OTC COVID-19 diagnostic tests. Last, FDA’s weekly roundup included a warning letter to the operator of a website for offering for sale in the U.S. unapproved drugs for multiple diseases, including COVID-19. (Authored by Randy Prebula)

• On 17 February, the U.S. Department of Justice (DOJ) Antitrust Division announced that it is launching a joint initiative with the Federal Bureau of Investigation (FBI) to “deter and prosecute those who would exploit supply chain disruptions to engage in collusive conduct.” In a statement announcing the initiative, Assistant Director Luis Quesada of the FBI’s Criminal Investigative Division said that the “lingering challenge” of supply chain disruptions stemming from the COVID-19 pandemic has created opportunities for price-fixing that has resulted in increased prices for consumers. Quesada pledged to work with law enforcement partners to investigate activity that violates the antitrust laws. Read more online here. (Authored by Katie Hellings)

• In response to the pandemic, the rise in telemedicine has rapidly changed patient care - as providers look to deliver services in a safe and effective way. While an impressive step-change, the use of telemedicine has certainly caught the attention of the Department of Justice as well as the qui tam relators’ bar. We’re seeing greater enforcement actions and an increase in False Claims Act (FCA) cases. In our latest FCA podcast episode, Hogan Lovells partners Gejaa Gobena and Michele Sartori dig into this a bit to find out what it means for companies in this space.

Wednesday, 16 February 2022

• FDA news: 

  • On Friday, the U.S. Food and Drug Administration (FDA) sent a letter to Eli Lilly allowing the emergency use of bebtelovimab for the treatment of mild-to moderate COVID-19 in adults and pediatric patients who are at high-risk for progression to severe COVID-19, including hospitalization or death.

  • FDA postponed a long-awaited review of COVID -19 vaccines for children younger than 5 years-old because it needs more data; the review may now take place in April at the earliest.

  • FDA held a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss a request to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine for administration to children 6 months through 4 years of age. (Authored by Randy Prebula)

• Other U.S. news:

  • Stakeholder concern is also growing about the end of the U.S. government’s declaration of a Public Health Emergency and the associated waivers of health care regulations. Currently set to expire on April 16, the Biden Administration has previously extended the PHE a number of times, but the federal government may pivot from the PHE this year, sparking concerns about a “COVID waiver cliff.”

  • The U.S. Health Resources and Services Administration (HRSA) is distributing $66.5 million to community groups working in 38 states and in Washington, D.C.; this the fourth round of the $250 million in funding allocated in the American Rescue Plan.

  • The U.S. Centers for Disease Control and Prevention (CDC) will not lift its masking recommendations until COVID-19 community transmission dips below "high" or "substantial levels," the agency's director, Rochelle Walensky, said on 9 Feb.

  • CDC released two new studies that discussed safety and effectiveness of the COVID-19 booster shots. In the first study, CDC found that people 18 years and older who received the same mRNA vaccine brand for all their vaccinations experienced fewer adverse reactions following the booster dose than they did after their second dose of mRNA vaccine. A second study reveals that a third dose of mRNA vaccine continues to offer high levels of protection against severe disease, even months after administration, underscoring the importance of staying up to date when eligible after receiving a primary series.

  • Reps. Kim Schrier (D-WA) and Richard Hudson (R-NC) introduced HR 6634, a bill to prevent and address staffing shortages during disaster and pandemic responses. (Authored by Cybil Roehrenbeck)

• In 2021, we saw an increasing number of carve out transactions as businesses spun off non-core or non-performing businesses or sold businesses to obtain capital for other activities. These types of transactions continue to accelerate as companies emerge from the COVID-19 pandemic. On 10 February, we held a webinar exploring structuring considerations and many of the key issues that need to be solved in a carve-out transactions, with focus on the U.S., UK, and Japanese markets, as well as cross-border coordination. Topics covered include principal structuring considerations; interface between the carve-out and the sale or spin-off process; key legal issues that frequently arise in the context of carve out transactions in these markets, and recommended solutions; as well as possible pit-falls in carve-out transactions and how to avoid them. (Authored by Ben Higson)

• Since the pandemic, cyber related crime is on the rise. And with that comes an increase in cyber fraud. Many of our clients who conduct business with the U.S. government are also keenly aware of the risks associated with the False Claims Act, which is the civil statute that permits treble damages for the government in a number of circumstances, including when a false or misleading claim for payment is made to the government. In the latest episode of our False Claims Act Guide: 2021 and the road ahead podcast, we discuss the now clear intersection between these two important issues. (Authored by David Sharfstein)

Wednesday, 9 February 2022

• In the latest edition of our False Claims Act Guide: 2021 and the road ahead, we analyze the key developments from 2021 and discuss how the most important cases and issues are shaping FCA enforcement now and in the year to come. For example, we explain how the easing of restrictions stemming from the COVID-19 pandemic has prompted a dramatic increase in the use of telehealth, which has in turn increased opportunities for fraud and abuse. In addition to the release of this annual guide, we are featuring a four-part podcast series based on select sections of the report. In episode one of this podcast, we discuss the rapid developments occurring in technology alongside great economic pressures brought on by the pandemic. We also talk about the new Administration that's settled into Washington, D.C. - one that seems to take a more aggressive approach to the enforcement of corporate crime. (Authored by Anthony Fuller)

• FDA news: Yesterday, the U.S. Food and Drug Administration (FDA) issued the guidance “COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels” to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, which are tunnels, walkways, chambers, and similar systems, that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19. Last week, FDA warned against using the E25Bio COVID-19 Direct Antigen Rapid Test (DART); the agency expressed concern about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test’s performance is accurate. Yesterday, FDA held a town hall on Coronavirus test development and validation. FDA has also extended the 506J notification draft guidance comment deadline by extended 30 days, to April 11; we have analyzed this guidance (“Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act”) online here. (Authored by Randy Prebula)

• U.S. News: Starting in early spring, Americans on Medicare and Medicare Advantage will be able to receive eight free over-the-counter (OTC) COVID-19 tests (per month) through their Medicare Part B coverage at participating pharmacies and other outlets, the Centers for Medicare and Medicaid Services (CMS) announced, touting how this is the first time that Medicare has covered an over-the-counter test at no cost to beneficiaries. Yesterday, the Senate HELP Committee held a hearing on “Lessons Learned from COVID-19: Highlighting Innovations, Maximizing Inclusive Practices and Overcoming Barriers to Employment for People with Disabilities." U.S. Sens. Baldwin (D-WI) and Cassidy (R-LA) have introduced the Tracing Pathogens Act, which purports to enhance the United States' ability to prepare for future pandemics and strengthen to conduct genomic sequencing for pathogens. The National Institutes of Health (NIH) announced that it is conducting a study to assess the antibody response to an additional dose of a COVID-19 mRNA vaccine in kidney and liver transplant recipients. (Authored by Cybil Roehrenbeck)

Wednesday, 2 February 2022

• Earlier this week, the U.S. Food and Drug Administration (FDA) approved the Moderna COVID-19 Vaccine (Spikevax) for the prevention of COVID-19 in individuals 18 years of age and older, which had been available under emergency use authorization (EUA), marking the second vaccine approved to prevent COVID-19. Also on Monday, FDA’s Center for Drug Evaluation and Research (CDER) issued the CDER Drug Safety Priorities 2021 report that details CDER’s work to manage drug safety issues through modernized safety surveillance methods and innovative responses to safety concerns, highlighting how CDER responded to the pandemic. (Authored by Randy Prebula)

• Last week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act” (“PREVENT Pandemics Act”), a sweeping package broadly intended to better prepare for future pandemics as well as the ongoing COVID-19 pandemic. Because the discussion draft carries bipartisan sponsorship, it is possible that at least some parts of it could ultimately be enacted into law. Several sections of the proposed legislation – relating to the use of real-world evidence (RWE), advanced platform technologies, and foreign facility inspections and registration – may have an immediate and significant impact on pharmaceutical and biotechnology companies, and we have summarized these key provisions online here. (Authored by Lowell Zeta)

• Other U.S. news: NIH published a study of the impact of a booster dose of any of the three COVID-19 vaccines authorized or approved in the U.S.  Rep. Gus Bilirakis (R-FL) wrote a letter to HHS Secretary Xavier Becerra regarding FDA’s decision to revoke EUAs for two monoclonal antibody drugs, noting that this decision forced all of the state’s monoclonal antibody treatment sites to close. Senators sent a letter on Jan. 28 with over 45 lawmakers asking for an extension of telehealth flexibilities provided during the COVID-19 pandemic. Rep. Morgan Griffith (R-VA) introduced the Domestic Security Using Production Partnerships and Lessons from Yesterday (SUPPLY) Act, which would require the Federal Government to enter into partnerships with domestic manufacturers of personal protective equipment (PPE) in order to ensure a supply of PPE during national emergencies. On 2-3 Feb., HHS will hold a meeting of the National Advisory Council on Nurse Education and Practice on the nursing workforce, nursing practice improvement, nursing education, and the response to the COVID-19 pandemic. A Texas court issued a nationwide injunction Friday blocking President Joe Biden's COVID-19 vaccination mandate for federal workers and effectively preventing the federal government from enforcing a mandate upon its own employees. Medicare recipients were not included in the Biden Administration order requiring private insurers to pay for up to eight at-home COVID-19 tests each month. (Authored by Cybil Roehrenbeck)

Wednesday, 26 January 2022

• In Germany, pharmaceutical and medical technology companies are already required to check the status of their employees as vaccinated, recovered, or negative tested before they enter their own workplaces or those of other employers. Visitors to certain facilities (e.g. hospitals, doctors' and dentists' surgeries) also require a negative test; however, these regulations expire on 19 March 2022. Moving forward, all persons working in certain facilities in Germany are subject to a "facility-related vaccination obligation" for the period from 16 March to 31 December 2022. The Federal Ministry of Health (BMG) has published FAQs on this topic. This shows that the regulation should also apply to employees of pharmaceutical and medical technology companies if they enter corresponding facilities for their work. We have summarized the most important points from these changes online here. (Authored by Joerg Schickert)

• An English employment tribunal decided that it was fair for an employer to dismiss a care home worker when she refused to be vaccinated against COVID-19. However, employers should not assume that the decision means that it will always be fair to dismiss employees for refusing vaccination. We have analyzed this case online here. (Authored by Ed Bowyer)

• FDA updates: The U.S. Food and Drug Administration (FDA) expanded the approved indication for Veklury and revised its Emergency Use Authorization (EUA). FDA announced Monday it revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. On 22 January, FDA added the following frequently asked question to the COVID-19 Test FAQs: Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures? On 21 January, FDA had updated the In Vitro Diagnostics EUAs – Molecular and Antigen Diagnostic Tests for SARS-CoV-2 web pages to add details about the design of SARS-CoV-2 diagnostic tests, including which authorized molecular and antigen diagnostic tests are designed with single or multiple viral targets, and which tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants. On 19 January, FDA authorized the MaximBio ClearDetect COVID-19 Antigen Home Test over-the-counter (OTC) COVID-19 antigen test. (Authored by Randy Prebula)

• Other U.S. news: Sen. Elizabeth Warren (D-MA) and six other Democratic lawmakers wrote a letter to Chief Scientific Officer for the COVID-19 Response Kessler and White House Coronavirus Response Coordinator Zients urging them to invoke the Defense Production Act (DPA) to increase the global supply of COVID-19 vaccines. Meanwhile, Sen. Ed  Markey (D-MA) also sent letters to at-home test manufacturers about the pricing of at-home rapid COVID-19 tests. The U.S. Health and Human Services Department (HHS) said recent requirements that at-home COVID-19 tests be reimbursed by insurers apply to U.S. citizens with private health coverage, but not for the millions covered under Medicare. Dr. Anthony Fauci said that the coronavirus pandemic won’t end with the elimination of the virus, but that a less dangerous and disruptive strain of the virus will likely take hold and become endemic. (Authored by Cybil Roehrenbeck)

• The U.S. District of Columbia (D.C.) released an updated poster on COVID-19 leave available under the D.C. Family and Medical Leave Act (DCFMLA). Employers with 20 or more employees in the District should promptly post this poster, as we explain online here. (Authored by George Ingham)

Wednesday, 19 January 2022

• Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to assist medical device manufacturers in providing timely, informative notifications about changes in the production of certain medical device products to help prevent or mitigate shortages of such devices as the government transitions out of temporary rules put in place for the duration of the public health emergency. This guidance does not apply only to the COVID-19 pandemic, but provides lasting recommendations to manufacturers on when and how they must notify FDA of a permanent discontinuance or interruption in manufacturing during a public health emergency or if the conditions are such that a public health emergency may well be imminent. FDA is accepting comments on the draft guidance through 11 March. We have have analyzed the draft guidance online here. (Authored by Jodi K. Scott and Randy Prebula)

• On 13 January, the U.S. Supreme Court reinstituted a stay on the Occupational Safety and Health Administration Emergency Temporary Standard (OSHA ETS), which mandated that employers with 100 or more employees require their employees to either be fully vaccinated for COVID-19 or get weekly tests. As a result of the ruling, employers subject to the OSHA ETS are no longer required to comply with it. At the same time, in a separate decision, the Court allowed the Centers for Medicare and Medicaid Services Interim Final Rule (CMS Rule) to take effect nationwide. The CMS Rule requires staff in most healthcare settings to be fully vaccinated for COVID-19, with limited exceptions. Employers with workers in health care settings should promptly establish a plan to comply with upcoming deadlines. We have analyzed the Supreme Court decision in depth online here. (Authored by George Ingham)

• How regulators from across the Americas are responding to the challenges posed by the COVID-19 pandemic and what lessons can be learned from this experience were the primary topics during the recent 10th Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs at the Center for Devices and Radiological Health (CDRH), was the keynote speaker in advance of a panel discussion on what the regional regulatory systems had done in response to the COVID-19 pandemic. Hillebrenner described the balancing act involved in CDRH’s evaluation of COVID-19 diagnostic and antibody tests, face masks, respirators, decontamination systems, and other products related to the pandemic. In a standard premarket review for a medical device, FDA evaluators look at whether a product is safe and effective, whereas in the EUA process they look at whether the product may be effective. Other factors are considered too, she explained, such as whether an adequate approved or available alternative to the product exists. (Authored by Randy Prebula)

Wednesday, 12 January 2022

• Yesterday, Acting FDA Commissioner Janet Woodcock, M.D., testified before the U.S. Senate HELP Committee in a hearing titled, “Addressing New Variants: A Federal Perspective on the COVID-19 Response.”  The U.S. Food and Drug Administration (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. These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), and includes information about reports of adverse events following use of the vaccine which suggest an increased risk of ITP during the 42 days following vaccination.  Last week, FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.  FDA recently issued warning letters to Varigard, LLC and to Amcyte Pharma, Inc. for selling unapproved products with fraudulent COVID-19 claims. (Authored by Randy Prebula)

• On 22 December 2021, FDA published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the COVID-19 public health emergency to increase availability of medical devices. The first draft guidance covers the transition plan for medical devices that were issued emergency use authorizations (EUAs) during the pandemic; and the second draft guidance applies to devices falling within the scope of FDA’s temporary enforcement discretion policies that will end as businesses return to normal operations. We have analyzed these documents in depth online here, and FDA will accept comments on the guidance documents until 23 March 2022. (Authored by Lina Kontos and Blake Wilson)

Compiled by Aaron Armstrong