Alston & Bird Health Care Week in Review, October 2, 2020

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:

On Thursday, HHS announced $20 billion in new Phase 3 CARES Act provider relief funding for COVID-19 front-line health care providers. Read more about the funding and other news below.

I. Regulations, Notices & Guidance

• On September 28, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Amendments and Requests for Final Approval to Tentatively Approved Abbreviated New Drug Applications. This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (earliest lawful approval date).
• On September 28, 2020, FDA issued guidance entitled, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use.
• On September 28, 2020, FDA issued guidance entitled, Breast Implants; Certain Labeling Recommendations to Improve Patient Communication. This guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. FDA is issuing this guidance to help ensure that a patient receives and understands the benefits and risks of breast implants. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of breast implants that uniquely pertain to individual patients.
• On September 28, 2020, FDA issued guidance entitled, Failure to Respond to an Abbreviated New Drug Application Complete Response Letter Within the Regulatory Timeframe. This guidance is intended to assist applicants in responding to complete response letters (CRLs) to ANDAs submitted to FDA under the FD&C Act. This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL as well as the actions that FDA may take if the applicant fails to respond to a CRL. In addition, this guidance recommends information an applicant may submit in its request for an extension to respond to a CRL as well as a non-exhaustive list of factors that FDA will consider in determining whether such a request is reasonable.
• On September 28, 2020, FDA issued guidance entitled, M7 Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. This draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk. Since the ICH M7 Guideline was finalized, the worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities. To facilitate the implementation of the ICH M7 Guideline, the ICH M7 Implementation Working Group has developed a series of questions and answers. The scope of this draft Q&A guidance follows that of the ICH M7 Guideline. The draft Q&A guidance is intended to clarify, promote the convergence of, and improve the harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided when developing drugs, completing marketing authorization applications, and using drug master files.
• On September 28, 2020, FDA issued guidance entitled, Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. This guidance described studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs), which are for over-the-counter (OTC) home use by lay users. This guidance is not meant to address blood glucose monitoring test systems (BGMS) that are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long-term care facilities).
• On September 29, 2020, FDA issued guidance entitled, E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential—Questions and Answers; International Council for Harmonisation. This draft guidance contains revised questions and answers for the ICH guidance for industry “E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs” and new Q&As for the ICH guidance for industry “S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals” that provide recommendations on considerations for an integrated risk assessment combining nonclinical and clinical data—in particular, at later stages of drug development when clinical data are available. The draft guidance is intended to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision making.
• On September 29, 2020, the Drug Enforcement Administration (DEA) issued a final rule entitled, Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. On April 6, 2009, the DEA published the interim final rule titled “Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008,” which amended DEA’s regulations by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. This action adopts the interim final rule as a final rule without change, apart from a minor technical amendment and certain changes to DEA regulations already made by intervening rules. This action also reinstates amendments that were inadvertently removed by the Controlled Substances and List I Chemical Registration and Reregistration Fees final rule published on March 15, 2012.
• On September 30, 2020, FDA issued guidance entitled, The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls. This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, new drug applications, or abbreviated new drug applications, and supplements to these applications, for oral drug product development, manufacturing changes, and controls. The guidance covers how to develop, evaluate, and apply PBPK models for biopharmaceutics-related uses, such as establishing clinically relevant dissolution specifications and quality risk assessment for post-approval manufacturing changes.
• On October 1, 2020, FDA issued guidance entitled, Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment. This draft guidance provides recommendations to sponsors regarding the development of drugs and biologics (referred to as drugs in this document) for the adjuvant treatment of renal cell carcinoma. The draft guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. This draft guidance is intended to facilitate the development of drugs for the adjuvant treatment of renal cell carcinoma.
• On October 1, 2020, FDA issued guidance entitled, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment. This guidance addresses clinical endpoints acceptable to demonstrate effectiveness of drugs for treatment of opioid use disorder. This guidance addresses comments received for and finalizes the draft guidance of the same name issued August 7, 2018.
• On October 1, 2020, FDA issued guidance entitled, Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment. This draft guidance provides recommendations to sponsors regarding the development of drugs and biologics for the adjuvant treatment of muscle-invasive bladder cancer. The draft guidance includes recommendations regarding eligibility criteria, choice of comparator, follow up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. This draft guidance is intended to facilitate the development of drugs for the adjuvant treatment of bladder cancer.
• On October 2, 2020, DEA issued a proposed rule entitled, Registering Emergency Medical Services Agencies under the Protecting Patient Access to Emergency Medications Act of 2017. The “Protecting Patient Access to Emergency Medications Act of 2017,” which became law on November 17, 2017, amended the Controlled Substances Act to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, this law allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The DEA proposes to amend its regulations to make them consistent with this law and to otherwise implement its requirements.

Event Notices   

• October 8, 2020: FDA announced a public meeting entitled, Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder.
• October 16, 2020: The Public Health Service (PHS) announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee. The committee will discuss responses to a charge on COVID-19 vaccination and may vote on sending these responses forward to the Director of the National Vaccine Program.
• October 26, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Board of Scientific Counselors, Center for Preparedness and Response (CPR). The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates.
• October 27, 2020: FDA announced a public meeting entitled, Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027 (MDUFA V).
• October 28-29, 2020: CDC announced a public meeting entitled, Meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID-19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID-19; and the clinical laboratory’s role in identifying health inequities during the COVID-19 response.
• October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.
• November 5, 2020: CDC announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
• November 6, 2020: FDA announced a public meeting entitled, Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease.
• November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.
• November 20, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The agenda will include discussions on current topics related to breast cancer in young women. These will include Mental/Behavioral Health, Sexual Health, Genetics and Genomics, and Provider Engagement.

II. Congressional Hearings

U.S. House of Representatives

• On September 30, 2020, the House Committee on Oversight and Reform held a hearing entitled, Unsustainable Drug Prices: Testimony from the CEOs (Part I). Witnesses present included Mark Alles, Former CEO, Celgene Corporation; Dr. Giovanni Caforio, CEO, Bristol Myers Squibb; and Kare Schultz, CEO, Teva Pharmaceuticals.
• On September 30, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Pathway to a Vaccine: Ensuring a Safe and Effective Vaccine People Will Trust. Witnesses present included Dr. Helene Gayle, MD, MPH, Co-Chair, Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, National Academies of Sciences, Engineering, and Medicine; Dr. Ashish K. Jha, MD, MPH, Dean, School of Public Health, Brown University; Dr. Ali S. Khan, MD, MPH, MBA, Dean, College of Public Health, University of Nebraska Medical Center; Dr. Mark McClellan, MD, Ph.D., Founding Director, Duke-Margolis Center for Health Policy, Duke University; and Dr. Paul A. Offit, MD, Director, Vaccine Education Center, Children’s Hospital of Philadelphia.
• On October 1, 2020, the House Committee on Oversight and Reform held a hearing entitled, Unsustainable Drug Prices: Testimony from the CEOs (Part II). Witnesses present included: Robert Bradway, CEO, Amgen, Inc.; Mark Trudeau, CEO, Mallinckrodt Pharmaceuticals; and Thomas Kendris, U.S. Country President, Novartis AG.
• On October 2, 2020, the House Select Subcommittee on the Coronavirus Crisis held a hearing with Secretary of Health and Human Services Alex Azar.

III. Reports, Studies & Analyses

• On September 28, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Affordability in the ACA Marketplace Under a Proposal Like Joe Biden's Health Plan. While Democratic Presidential Candidate Joe Biden’s public option proposal has received significant attention, his proposal to expand Affordable Care Act (ACA) premium subsidies has not been the subject of much public discussion or analysis, especially his plan to extend eligibility for subsidies to people with employer coverage. This analysis examines current insurance affordability challenges under the ACA, and the effects of a proposal like Biden’s to expand subsidies for people currently purchasing Marketplace or employer coverage.
• On September 30, 2020, KFF published an issue brief entitled, Effects of the ACA Medicaid Expansion on Racial Disparities in Health and Health Care. This issue brief builds on a previous literature review that broadly investigated the effects of Medicaid expansion by examining how the expansion has affected racial disparities in health coverage, access to care, health outcomes, and economic outcomes. It is based on a review of 65 studies published beginning in January 2014 (when the coverage provisions of the ACA went into effect) through July 2020. This brief groups outcomes into four broad categories: coverage; access to and use of care; health outcomes and quality of care; and economic measures.
• On October 1, 2020, the Government Accountability Office (GAO) published a report entitled, Prescription Drug Monitoring Programs: Views on Usefulness and Challenges of Programs. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act includes a provision for GAO to study the operation of prescription drug monitoring programs (PDMPs). In this report, GAO describes (1) physicians’ views on the usefulness of PDMPs when making patient care decisions; and (2) challenges to using PDMPs when making patient care decisions, as well as state and federal efforts to address these challenges.

IV. Other Health Policy News

• On September 28, 2020, President Trump announced his Administration’s plans for distributing the 150 million Abbott BinaxNOW Ag Card rapid tests they purchased on August 27, 2020. At a press briefing on the subject, President Trump said that 50 million of these tests will be sent to the most vulnerable communities, including 18 million to nursing homes, 15 million for assisted living facilities, 10 million for home health and hospice care agencies, and 1 million for historically black colleges and universities. The remaining 100 million tests will be distributed to states and territories over the next few weeks at no cost to support efforts to reopen their economies and schools. More information about this announcement can be found here.
• On September 29, 2020, the Department of Health and Human Services (HHS) announced that it is launching an initiative to measure health information technology (health IT) use among office-based physicians across the country. More information about this initiative can be found here.
• On September 29, 2020, CMS announced an update to the methodology the agency employs to determine the rate of COVID-19 positivity in counties across the country. This information is critical to nursing homes, which are required to test their staff for COVID-19 at a frequency based on the positivity rate of their respective counties. More information about the updated testing methodology can be found here.
• On September 30, 2020, CMS released its first monthly Medicaid and CHIP Enrollment Trends Snapshot. This new summary report captures impacts of the COVID-19 Public Health Emergency by tracking total Medicaid and CHIP program enrollment trends for adults and children over a 12-month period. The monthly snapshot can be found here.
• On October 1, 2020, HHS announced that approximately $2.24 billion in Ryan White HIV/AIDS Program grants were awarded to cities, counties, states, and local community-based organizations in fiscal year (FY) 2020. More information about this funding can be found here.
• On October 1, 2020, HHS, through the Health Resources and Services Administration (HRSA), announced $20 billion in new funding for providers on the frontlines of the coronavirus pandemic. Under this Phase 3 General Distribution allocation, providers that have already received Provider Relief Fund (PRF) payments will be invited to apply for additional funding that considers financial losses and changes in operating expenses caused by the coronavirus. Previously ineligible providers, such as those who began practicing in 2020, will also be invited to apply, and an expanded group of behavioral health providers confronting the emergence of increased mental health and substance use issues exacerbated by the pandemic will also be eligible for relief payments. Providers can begin applying for funds on Monday, October 5, 2020. More information about this new PRF allocation can be found here.
• On October 2, 2020, HHS Secretary Alex Azar renewed the COVID-19 public health emergency, extending it for another three months, unless terminated sooner.

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