Alston & Bird Healthcare Week in Review - July 2020 #4

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care 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 Friday, President Donald Trump signed four executive orders aimed at lowering the cost of prescription drugs in the U.S. Read more about this executive action and other news below.


I. Regulations, Notices, & Guidance

  • On July 20, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. The guidance does not alter FDA’s current thinking on the regulatory criteria of minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based product (HCT/P). The guidance announced in this notice supersedes the guidance of the same title dated November 2017 and corrected December 2017. The guidance revises section V of the November 2017 guidance to communicate that FDA is extending the period of time during which it intends to exercise enforcement discretion regarding certain regulatory requirements for certain HCT/Ps; this time period will run through May 31, 2021, instead of November 30, 2020.
  • On July 20, 2020, FDA issued guidance entitled, Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders. This guidance document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility's accreditation, and/or a suspension or revocation of certificate, and/or a patient and physician notification order.
  • On July 21, 2020, FDA issued a final rule entitled, Medical Devices; Exemptions From Premarket Notification: Class II Devices. This order sets forth the FDA’s final determination to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the list of class II devices. The exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain federal regulations. FDA is also amending the codified language for the list of class II devices to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • On July 21, 2020, FDA issued guidance entitled, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. This draft guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived products: the source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products. This draft guidance has been developed to help support clinical research into development of cannabis and cannabis-derived products.
  • On July 21, 2020, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) issued guidance entitled, Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements. The document is intended primarily for institutions, IRBs, investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of nonexempt research involving human subjects conducted or supported by HHS.
  • On July 23, 2020, the Drug Enforcement Administration (DEA) issued a final rule entitled, Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants. The DEA is adjusting the fee schedule for registration and reregistration fees necessary to recover the costs of its Diversion Control Program relating to the registration and control of the manufacture, distribution, dispensing, importation and exportation of controlled substances and list I chemicals as mandated by the Controlled Substances Act (CSA). This final rule adopts the notice of proposed rulemaking published on March 16, 2020, to change the fee schedule and codify existing practices of the issuance of refunds by DEA for applicant registration fees, without change.
  • On July 23, 2020, the FDA issued a proposed rule entitled, Annual Summary Reporting Requirements Under the Right to Try Act. To facilitate implementation of the reporting requirements of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act), FDA is proposing to establish requirements for the deadline and contents of submission of an annual summary. This proposed rule, if finalized, would implement the statutory requirement under provisions of the Right to Try Act for submission of an annual summary by sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient.

Event Notices

  • July 25, 2020: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Outreach and Education (APOE). The purpose of the meeting is to discuss opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
  • July 30, 2020: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the National Advisory Committee on Rural Health and Human Services. At this meeting, the National Advisory Committee on Rural Health and Human Services (NACRHHS) will discuss the development of a vision statement that emphasizes rural community transformation, sustainable services, and resiliency.
  • August 6, 2020: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on HIV/AIDS. The purpose of the meeting is to discuss COVID-19 and HIV, and Ready, Set, PrEP enrollment.
  • August 11, 2020: FDA announced a public meeting entitled, Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI. The meeting will include a presentation from an independent third-party contractor about its assessment of FDA-sponsor communications during the investigational new drug (IND) stage of drug/biologic development in the Prescription Drug User Fee Act (PDUFA) VI; a series of presentations by and a panel discussion with invited regulatory and industry representatives, and an open public comment period.
  • August 13, 2020: FDA announced a public meeting entitled, Meeting of the Oncologic Drugs Advisory Committee. The committee will discuss biologics license application 125706, for remestemcel-L (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion), submitted by Mesoblast, Inc. The proposed indication for this product is for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.
  • August 26, 2020: 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 COVID-19 vaccines.
  • September 15, 2020: FDA announced a public meeting entitled, Meeting of the Pediatric Advisory Committee. The committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).

II. Congressional Hearings

U.S. House of Representatives

  • On July 20, 2020, the House Committee on Oversight and Reform Subcommittee on Government Operations hearing entitled, Federal IT Modernization: How the Coronavirus Exposed Outdated Systems. Witnesses present included: Gordon Bitko, Senior Vice President of Policy, Information Technology Industry Council; Matthew Cornelius, Executive Director, Alliance for Digital Innovation; Steve O’Keeffe, Founder, MeriTalk; and Hana Schank, Director of Strategy, Public Interest Technology, New America.
  • On July 21, 20202, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing entitled, Pathway to a Vaccine: Efforts to Develop a Safe, Effective, and Accessible COVID-19 Vaccine. Witnesses present included: Dr. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca; Dr. Macaya Douoguih, Head of Clinical Development and Medical Affairs, Janssen Vaccines, Johnson & Johnson; Dr. Julie Gerberding, Executive Vice President and Chief Patient Officer, Merck; Dr. Stephen Hoge, President, Moderna; and Mr. John Young, Chief Business Officer, Pfizer.
  • On July 22, 2020, the House Committee on Homeland Security hearing entitled, Examining the National Response to the Worsening Coronavirus Pandemic: Part II. Witnesses present included: Hon. Peter T. Gaynor, Administrator, Federal Emergency Management Agency.
  • On July 23, 2020, the House Committee on Ways and Means Subcommittee on Trade hearing entitled, Trade, Manufacturing, and Critical Supply Chains: Lessons from COVID-19. Witnesses present included: Erica Fuchs, Professor of Engineering and Public Policy, Carnegie Mellon University; Dr. Prashant Yadav, Senior Fellow, Center for Global Development; Ms. Roxanne Brown, International Vice President at Large, United Steelworkers; Ms. Kim Glas, President and CEO, National Council of Textile Organizations; and Dr. Thomas Duesterberg, Senior Fellow, Hudson Institute.

U.S. Senate

  • On July 21, 2020, the Senate Committee on Aging held a hearing entitled, , The COVID-19 Pandemic and Seniors: A Look at Racial Health Disparities. Witnesses present included: Dominic Mack, Professor of Family Medicine and Director of the National Center for Primary Care, Morehouse School of Medicine; Dr. Mercedes Carnethon, Professor of Epidemiology and Vice Chair of the Department of Preventive Medicine, Northwestern University; Eugene Woods, President and CEO, Atrium Health; and Rodney Jones, Sr., CEO, East Liberty Health Center.

III. Reports, Studies, & Analyses

  • On July 21, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, An Early Look at 2021 Premium Changes on ACA Exchanges and the Impact of COVID-19 on Rates. This brief summarizes preliminary premium rate filings in the 10 states and the District of Columbia where filings have been made publicly available in a way that shows how premiums are calculated. The authors reviewed published filings for the overall average premium increase across all plans and any language or estimate attributing a portion of the rate change to the impacts of the coronavirus pandemic. Thus far, many rate changes for 2021 appear to be moderate, with increases or decreases of a few percentage points. However, because many insurers have not yet incorporated a rate impact from the pandemic, it is too soon to say how Marketplace premiums will change next year.
  • On July 21, 2020, KFF published an issue brief entitled, How Much Fiscal Relief Can States Expect From the Temporary Increase in the Medicaid FMAP? This brief examines how much fiscal relief states can expect from the increase in the FMAP under The Families First Coronavirus Response Act under different assumptions about the duration of the relief, how the FMAP increase provides broad fiscal relief to states, and the factors that affect how much relief is available across states.

IV. Other Health Policy News

  • On July 20, 2020, the HHS Office for Civil Rights (OCR) issued guidance to ensure that recipients of federal financial assistance understand that they must comply with applicable federal civil rights laws and regulations that prohibit discrimination on the basis of race, color, and national origin in HHS-funded programs during COVID-19. This bulletin focuses on recipients' compliance with Title VI of the Civil Rights Act of 1964 (Title VI). More information on the guidance can be found here.
  • On July 21, 2020, HHS announced the creation of a new national COVID-19 Testing Implementation Forum. This program is intended to capture feedback between federal officials and the private sector and will bring together representatives from key stakeholder groups to share information and provide input to federal leaders about SARS-CoV-2, testing, and diagnostics. Members of the forum will provide their perspectives on how HHS can best identify and address end-to-end testing supply chain issues across commercial, public health, academic, and other sectors and define optimal testing in various settings (diagnostic, screening, surveillance, others). More information on this new forum can be found here.
  • On July 22, 2020, CMS announced several new initiatives designed to protect nursing home residents from COVID-19. These initiatives include providing new funding to build nursing home skills and enhance nursing homes’ response to COVID-19; enhanced testing requirements; providing additional technical assistance and support for nursing homes; and releasing weekly data on high-risk nursing homes. More information about these initiatives can be found here.
  • On July 24, 2020, President Trump signed four executive orders aimed at lowering the cost of prescription drugs in the U.S. The first order will require federal community health centers to pass the 340B Program discounts they receive from drug companies on insulin and EpiPens directly to their patients. The second order will allow states, wholesalers, and pharmacies to import drugs from Canada and other countries where the price of drugs is much lower. The third order will target pharmacy benefit managers and ensure that the discounts PBMs receive from drug companies are passed on directly to patients. The fourth order will require Medicare to purchase drugs at the same price that other countries pay. Under this final order, Medicare will determine what other medically advanced nations pay for their most expensive drugs and negotiate based on this information. President Trump announced that his administration will not implement this fourth order until August 24, 2020, providing drug companies with 30 days to respond and provide viable alternatives for lowering the cost of drugs. More information about the executive orders can be found here.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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