Alston & Bird Health Care Week in Review - June 2021 #1

Alston & Bird

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 Biden Administration unveiled its strategy for global vaccine sharing. Read more about the plan and other news below.

I. Regulations, Notices & Guidance

  • On June 2, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations. This draft guidance provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube. In addition, it supports the development of clear product-specific enteral tube administration instructions in labeling for administration to patients unable to ingest oral drug products.
  • On June 3, 2021, FDA issued guidance entitled, Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act. The draft guidance is intended to help industry better understand the definitions of “suspect” and “illegitimate” product as defined in the Drug Supply Chain Security Act (DSCSA). The draft guidance lays out FDA’s current understanding of the following key terms used to define “suspect” and “illegitimate” product: “Counterfeit,” “diverted,” “stolen,” “fraudulent transaction,” and “unfit for distribution.” This revised draft guidance clarifies certain points of the draft guidance for industry “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act” issued in March 2018 (March 2018 draft guidance), including FDA’s current understanding of the term “stolen.”
  • On June 3, 2021, FDA issued guidance entitled, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA. The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. In addition, this guidance describes when manufacturers should notify FDA of a high risk that a product is illegitimate.
  • On June 3, 2021, FDA issued guidance entitled, Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act. The DSCSA outlines critical enhanced drug distribution security requirements for building an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs at the package level as they are distributed within the United States. This draft guidance clarifies these requirements and provides recommendations on the system attributes necessary to enable the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary.
  • On June 3, 2021, FDA issued guidance entitled, Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers. The guidance is intended to address questions regarding product identifiers that, under the FD&C Act as amended by the DSCSA, are required to be affixed to, or imprinted on, packages and homogenous cases of certain drug products intended to be introduced in a transaction into commerce. This guidance is intended to clarify FDA’s interpretation of these requirements, including as they relate to the linear barcode requirements under the Code of Federal Regulations.

Event Notices

  • June 9, 2021: FDA announced a public workshop entitled, Model Informed Drug Development Approaches for Immunogenicity Assessments. The purpose of this public workshop is to discuss the best practices and future directions of quantitative methods for predicting immunogenicity of biological products.
  • June 16-17, 2021: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During this meeting, NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
  • June 23, 2021: FDA announced a public workshop entitled, Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
  • June 24, 2021: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting regarding new and reconsidered clinical diagnostic laboratory test codes for the Clinical Laboratory Fee Schedule for calendar year (CY) 2022. This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for CY 2022. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
  • June 29-30, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This meeting will be dedicated to the council’s deliberation and vote on two reports to transmit to the HHS Secretary, the first from the Disparities in Antibiotics Access and Use Working Group, and the second from the Working Group on Antimicrobial Resistance (AMR) in Inter-Professional Education. The remainder of the two-day public meeting will include an update on the status of the antibiotic development pipeline and an open council discussion on provocative questions in AMR (no recommendations will be made), in addition to presentations from subject matter experts on Operationalizing One Health and the Environmental Dimensions of AMR.
  • July 28-29, 2021: CMS announced a public meeting entitled, Meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The purpose of the Panel is to advise the HHS Secretary and CMS Administrator on issues related to clinical diagnostic laboratory tests.

II. Congressional Hearings

There were no health-related hearings this week.

III. Reports, Studies & Analyses

  • On June 2, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Are Health Centers Facilitating Equitable Access to COVID-19 Vaccinations? Community health centers are a national network of safety net primary care providers and are a primary source of care for many low-income populations and communities of color. This updated analysis examines the extent to which COVID-19 vaccination efforts through community health centers are reaching people of color using data from the federal government’s weekly Health Center COVID-19 Survey for the weeks of January 8 through May 21, 2021 (the latest data available).

IV. Other Health Policy News

  • On June 1, 2021, HHS announced it is launching a partnership with the nonprofit organization Global Health Investment Corporation (GHIC) to accelerate development and commercialization of technologies and medical products needed to respond to or prevent public health emergencies, such as pandemics, and other health security threats. More information about this partnership can be found here.
  • On June 3, 2021, the Biden Administration unveiled its strategy for global vaccine sharing. This framework reveals the Administration’s plans for sharing at least 80 million U.S. vaccine doses globally by the end of June and the plan for the first 25 million doses. More information about this announcement can be found here.
  • On June 4, 2021, CMS issued the 2021 Navigator Notice of Funding Opportunity (NOFO), which will make $80 million in grant funding available to Navigators in states with a Federally-Facilitated Marketplace (FFM) for the 2022 plan year. This is the largest funding allocation CMS has made available for Navigator grants to date. More information on this funding decision 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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