Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the House of Representatives began marking up legislative proposals for COVID-19 relief under the budget reconciliation process. Read more about this action and other news below.
I. Regulations, Notices & Guidance
- On February 10, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency. Due to the COVID-19 pandemic, the FDA has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
- On February 11, 2021, FDA issued guidance entitled, Investigational COVID-19 Convalescent Plasma. On August 23, 2020, FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA has subsequently reissued this EUA with revisions. FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND). For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.
- On February 11, 2021, the Department of Health and Human Services (HHS) delayed implementation of a final rule entitled, National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table. In accordance with the Presidential directive as expressed in the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled ‘‘Regulatory Freeze Pending Review,’’ this action proposes, following a brief public comment period, to further delay until April 23, 2021, the effective date of the rule entitled “National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,” published in the Federal Register on January 21, 2021. That final rule is scheduled to take effect on February 22, 2021. HHS seeks comments on this proposed delay, which would allow it additional opportunity for review and consideration of the new rule.
- February 17, 2021: HHS announced a public meeting entitled, Tenth Meeting of the National Clinical Care Commission. The tenth meeting will consist of updates from the Commission’s three subcommittees, and include another round of potential “action plans,” or recommendations, from each subcommittee.
- February 24-25, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on cholera vaccine, hepatitis B vaccine, influenza vaccines, zoster vaccine, orthopoxvirus vaccine, pneumococcal vaccine, rabies vaccine, and tickborne encephalitis vaccine. A recommendation vote on the rabies vaccine is scheduled.
- February 26, 2021: HHS announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to introduce Task Force members and to outline the charges as directed by Executive Order 13995, Ensuring an Equitable Pandemic Response and Recovery.
- March 5, 2021: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 influenza season.
- March 24-25, 2021: FDA announced a public meeting entitled, Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss biologics license application (BLA) 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate.
II. Congressional Hearings
U.S. House of Representatives
- On February 10-11, 2021, the House Committee on Ways and Means held a markup of COVID-19 Relief Measures under the budget reconciliation process, including several health-related provisions. All provisions considered were advanced to the House Committee on Budget along party lines. Health-related measures include the following:
- Subtitle E. Budget Reconciliation Legislative Recommendations Relating to Support to Skilled Nursing Facilities in Response to COVID-19.
- Subtitle F. Budget Reconciliation Legislative Recommendations Relating to Continuation of Job-Based Coverage.
- Subtitle F. Budget Reconciliation Legislative Recommendations Relating to Promoting Economic Security.
- On February 11-12, 2021, the House Committee on Energy and Commerce held a markup of COVID-19 relief measures under the budget reconciliation process, including several health-related provisions. All health-related provisions considered were advanced to the House Committee on Budget along party lines. Health-related measures include the following:
III. Reports, Studies & Analyses
- On February 10, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, The Implications of COVID-19 for Mental Health and Substance Use. This brief explores mental health and substance use during, and prior to, the COVID-19 pandemic. It focuses on populations that were particularly at risk for experiencing negative mental health or substance abuse consequences during the pandemic, including young adults, people experiencing job loss, parents and children, communities of color, and essential workers.
- On February 11, 2021, KFF published an issue brief entitled, A Status Report on Prescription Drug Policies and Proposals at the Start of the Biden Administration. In recent years, federal and state policymakers have introduced several proposals to lower prescription drug costs in an attempt to respond to the public’s ongoing concerns about high and rising drug prices. As President Biden takes the reins, his administration inherits a handful of final rules advanced by the Trump Administration in its final months related to Medicare, importation, and 340B pricing for insulin and epinephrine. It also seems likely that lawmakers in the new 117th Congress will push to enact some of the key drug pricing proposals related to Medicare and drug prices more generally that were voted on but not enacted into law in the previous session. In this brief, the authors provide a status update on these final rules and an overview of key Medicare-related drug pricing proposals supported by President Biden during the campaign that may return to the forefront of health policy discussions in the coming years.
- On February 11, 2021, the Government Accountability Office (GAO) published a report entitled, Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges. GAO was asked to review Operation Warp Speed (OWS) vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines; (2) how developmental processes have been adapted to meet OWS timelines; and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges.
IV. Other Health Policy News
- On February 11, 2021, HHS and the Department of Defense (DOD) announced they have purchased an additional 100 million doses of COVID-19 vaccines from both Pfizer Inc. and Moderna Inc. to help meet demand for COVID-19 vaccines in the United States. More information about this announcement can be found here.
- On February 12, 2021, the Centers for Medicare & Medicaid Services (CMS) announced that the Special Enrollment Period (SEP) for the Health Insurance Marketplace® will officially be available to consumers in the 36 states that use the HealthCare.gov platform on Monday, February 15, and will continue through Saturday, May 15. At least 13 States plus the District of Columbia, which operate their own Marketplace platforms, have decided to offer a similar opportunity. More information about the SEP can be found here.
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