General Publications February 15, 2019

Alston & Bird Healthcare Week in Review, February 15, 2019

Alston & Bird’s Week in Review 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.

I. Regulations, Notices, & Guidance

  • On February 11, 2019, the National Institutes of Health (NIH) issued a notice entitled, Request for Information for a Review of the NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding Document. Through this Request for Information, the Office of AIDS Research in the Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH invites feedback from interested stakeholders on a review of the NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding (NOT-OD-15-137) now entering year four of implementation. The original Notice was released on August 12, 2015 to inform the scientific community of the overarching HIV/AIDS research priorities and the guidelines used by NIH to determine HIV/AIDS funding beginning in fiscal year 2016 for the next three to five years.
  • On February 13, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Center for Drug Evaluation and Research’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality; Draft Guidance for Industry; Availability. This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. This program, once established, will facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition. CDER believes that this informal program, which is different than the formal recognition standards program in FDA’s Center for Devices and Radiological Health, will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications for products regulated by CDER. CDER is issuing this draft guidance to obtain public comments on the proposed program.
  • On February 15, 2019, the FDA issued guidance entitled, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. The guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life threatening diseases or conditions with FDA's recommendations on the expedited development and review of these therapies. The guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions, including those products designated as regenerative advanced therapies (which FDA refers to as "regenerative medicine advanced therapy'' (RMAT) designation). The guidance also describes considerations in the clinical development of regenerative medicine therapies and opportunities for sponsors of regenerative medicine therapies to interact with the Center of Biologics Evaluation and Research review staff.
  • On February 15, 2019, the FDA issued guidance entitled, Competitive Generic Therapies; Draft Guidance for Industry; Availability. This draft guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT. This draft guidance also includes information on the actions FDA may take to expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. This draft guidance also provides information on how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for drugs designated as CGTs.

Event Notices   

  • February 20, 2019: The Health Information Technology Advisory Committee announced a public meeting. The Committee will develop recommendations to the National Coordinator on interoperability.
  • February 27, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment National Advisory Council (NAC). The NAC will discuss recovery housing and expanding access to medication-assisted treatment.
  • April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.

II. Congressional Legislation & Committee Action

U.S. Senate

  • On February 12, 2019, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, Managing Pain During the Opioid Crisis. Witnesses present included: Cindy Steinberg, U.S. Pain Foundation, Policy Council Chair; Halena Gazelka, MD, Mayo Clinic Inpatient Pain Service Chair, Mayo Clinic Opioid Stewardship Program; Andrew Coop, PhD, Professor and Associate Dean for Academic Affairs; and Anuradha Rao-Patel, MD, Lead Medical Director, Blue Cross and Blue Shield of North Carolina.

House of Representatives

  • On February 12, 2019, the House Ways and Means Committee held a hearing entitled, the Rising Cost of Prescription Drug Prices. Witnesses present included: Odunola Ojewumi, Cancer Patient, Testifying on behalf of Families USA; Mark E. Miller, PhD, Executive Vice President of Health Care, Arnold Ventures; Rachel Sachs, Associate Professor of Law, Washington University in St. Louis, MO; Alan Ruether, Legislative Consultant, UAW Retiree Medical Benefits Trust; and Joseph R. Antos, PhD, Wilson H. Taylor Scholar In Health Care and Retirement Policy, American Enterprise Institute.
  • On February 13, 2019, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Strengthening Our Health Care System: Legislation to Reverse ACA Sabotage and Ensure Pre-Existing Conditions Protections. Witnesses present included: Grace-Marie Turner, President, Galen Institute, Katie Keith, Associate Research Professor and Adjunct Professor of Law, Georgetown University; and Jessica Altman, Commissioner, Pennsylvania Insurance Department.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On February 15, 2019, the Centers for Medicare & Medicaid Services proposed a policy to cover FDA-approved Chimeric Antigen Receptor (CAR) T-cell therapy. Currently, there is no national Medicare policy for covering CAR T-cell therapy so Medicare Administrative Contractors have discretion over whether to pay for it. The proposed coverage determination would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study. The proposed coverage decision is available here.
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