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, HHS Secretary Alex Azar extended the COVID-19 Public Health Emergency, and the department issued two final rules. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On January 4, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Mouse Embryo Assay for Assisted Reproduction Technology Devices. This guidance document provides recommendations on conducting the mouse embryo assay to support premarket submissions and lot release of assisted reproduction technology devices.
- On January 4, 2021, FDA issued guidance entitled, Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations. FDA is publishing this draft guidance to help sponsor-investigators developing individualized antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening genetic disease. Most often, individuals with such diseases will not have adequate alternative therapy available for treating their disease. This draft guidance is intended to help sponsors of such development programs, who may be relatively unfamiliar with FDA regulations, processes, and practices, with the administrative and procedural aspects of interacting with FDA, including seeking feedback from FDA on their development programs and making regulatory submissions related to these development programs.
- On January 5, 2021, FDA issued guidance entitled, Safer Technologies Program for Medical Devices. This final guidance describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k)), taking into account the specific eligibility factors described in this guidance. Consistent with the Agency's statutory mission to protect and promote public health, FDA believes that this "Safer Technologies Program" or "STeP" will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.
- On January 5, 2021, FDA issued guidance entitled, Human Gene Therapy for Neurodegenerative Diseases. Neurodegenerative diseases are a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. The draft guidance document provides recommendations to sponsors developing a human gene therapy (GT) product for neurodegenerative diseases affecting adult and pediatric patients. The guidance focuses on considerations for product development, preclinical testing, and clinical trial design.
- On January 6, 2021, FDA issued guidance entitled, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The purpose of this guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the FDA regarding potential or planned medical device Investigational Device Exemption (IDE) applications, PMA applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act).
- On January 7, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled, Health and Human Services Grants Regulation. This final rule repromulgates and adopts changes to certain provisions in the Department’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS awards (UAR). This rule repromulgates sections of the UAR dealing with payments, access to records, indirect allowable cost requirements, and a portion of the provision dealing with shared responsibility payments under the Affordable Care Act. This rule also amends sections dealing with national policy requirements to bring them into compliance with the authority under which the UAR is promulgated and OMB guidance, as well as to reflect those nondiscrimination requirements that have been adopted by Congress.
- On January 8, 2021, HHS issued a final rule entitled, Securing Updated and Necessary Statutory Evaluations Timely. The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department’s regulations have appropriate impacts, HHS is issuing this final rule amending its regulations to set expiration dates for the Department’s regulations (subject to certain exceptions), unless the Department periodically assesses the regulations to determine if they are subject to the RFA, and if they are, performs a review that satisfies the criteria in the RFA.
- January 19, 2021: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The purpose of the meeting is for the Institute Director and other Institute staff to present their report.
- January 25, 2021: HHS announced a public meeting entitled, Meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The Advisory Council will hear presentations on the impact of COVID-19 on people with dementia, health disparities in dementia research, and the implications of new technologies to identify Alzheimer’s disease through a blood tests.
- February 2, 2021: FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
- February 2, 2021: NIH announced a public meeting entitled, Meeting of the National Advisory Child Health and Human Development Council. The agenda will include opening remarks, administrative matters, Director’s Report, Division of Extramural Research Report, and other business of the Council.
- February 4, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
- February 10-11, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria (PACCARB). The February 10-11 public meeting will be dedicated to presentations from two new working groups of the PACCARB, one on Inter-Professional Education and another on Antibiotics Access and Use, which were formed in response to a task letter from the Assistant Secretary for Health. The two-day virtual public meeting will also include an update on the impact of COVID-19 on antimicrobial resistance.
- February 11, 2021: NIH announced a public meeting entitled, Meeting of the National Cancer Institute President’s Cancer Panel. The purpose of the meeting is to discuss innovation to increase cancer screening.
- February 11-12, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. During the meeting, the Advisory Committee will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a presentation on potential processes for reviewing conditions on the RUSP; potential revisions to the condition nomination form; continuity of operations planning; innovations in long-term follow-up for conditions identified through newborn screening; and workgroup dates.
II. Congressional Hearings
There were no health-related Congressional events this week.
III. Reports, Studies & Analyses
IV. Other Health Policy News
- On January 6, 2021, HHS announced two upcoming actions by the Centers for Disease Control and Prevention (CDC) to provide more than $22 billion in funding to states, localities, and territories in support of the nation's response to the COVID-19 pandemic, as directed by the Coronavirus Response and Relief Supplemental Appropriations Act. Funding will provide critical support for testing and vaccination-related activities to jurisdictions before January 19, 2021. Specifically, more than $19 billion will go to jurisdictions through the existing CDC Epidemiology and Laboratory Capacity (ELC) cooperative agreement and over $3 billion will go to jurisdictions through the existing CDC Immunization and Vaccines for Children cooperative agreement. More information about this funding distribution can be found here.
- On January 7, 2021, HHS Secretary Alex Azar renewed the current COVID-19 Public Health Emergency (PHE), which would have ended on January 20, 2021. The renewal is effective on January 21, 2021.
- On January 7, 2021, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state health officials designed to drive the adoption of strategies that address the social determinants of health (SDOH) in Medicaid and the Children’s Health Insurance Program (CHIP) so states can further improve beneficiary health outcomes, reduce health disparities, and lower overall costs in Medicaid and CHIP. More information on this guidance can be found here.
- On January 7, 2021, HHS announced the extension of the Community Based Testing Site program for COVID-19 testing, through partnership with national pharmacy and retail chains CVS, Rite-Aid, Walgreens, Quest (through services at Walmart) and service provider eTrueNorth (through services at Health Mart and Topco locations). More information about this announcement can be found here.