August 9, 2019

Alston & Bird Healthcare Week in Review, August 9, 2019

Below is Alston & Bird’s Healthcare 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.

I. Regulations, Notices, & Guidance

  • On August 6, 2019, the Food and Drug Administration (FDA) issued a notice entitled, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products.
  • On August 6, 2019, FDA issued a notice entitled, Request for Nominations: Nonvoting Industry Representatives on the Vaccines and Related Biological Products Advisory Committee. The FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the VRBPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
  • On August 6, 2019, the Health Resources and Services Administration (HRSA) issued a notice entitled, Agency Information Collection Activities; Proposals, Submissions, and Approvals: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program. In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. Comments on this ICR should be received no later than September 6, 2019.
  • On August 7, 2019, FDA issued guidance entitled, Fabry Disease: Developing Drugs for Treatment Guidance for Industry. This draft guidance describes the FDA’s current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints to be used in clinical development programs of investigational drugs to treat Fabry disease. Through this draft guidance, the FDA provides clear and specific guidance to foster greater efficiency in drug development in this rare disease with the goal of enhancing clinical trial data quality and supporting the development of treatments for Fabry disease.
Event Notices         
  • August 21, 2019: The Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Center for Substance Abuse Prevention. The meeting will include discussion of the substance use prevention workforce, as well as marijuana and HIV. The meeting will also include updates on Center for Substance Abuse Prevention (CSAP) program developments.
  • August 22-23, 2019: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The topics to be discussed during this meeting will include strategies to improve the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities with an emphasis on infectious disease, particularly HIV and Hepatitis B. The recommendations will be given to the Deputy Assistant Secretary for Minority Health.
  • September 9-11, 2019: HRSA announced a public meeting entitled, National Advisory Committee on Rural Health and Human Services. The National Advisory Committee on Rural Health and Human Services (NACRHHS) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning both rural health and rural human services. During the September 9, 2019, through September 11, 2019, meeting, NACRHHS will examine the current delivery of health care and human services in rural areas. Agenda items are subject to change as priorities dictate. Refer to the NACRHHS website for any updated information concerning the meeting.
  • November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the public meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's (CDER's) Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.

II. Congressional Hearings

There were no health-related hearings this week.

III. Reports, Studies, & Analyses

  • On August 7, 2019, the Government Accountability Office (GAO) released a report entitled, Generic Drug Applications: FDA Should Take Additional Steps to Address Factors That May Affect Approval Rates in the First Review Cycle. Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for FDA approval to market them. After reviewing an application, FDA may return it with comments. The company can address the comments and resubmit. On average, applications go through three of these review cycles before approval (which may take years). GAO found that FDA approved 12 percent of generic drug applications in the first cycle in 2015-2017. FDA took steps to try to increase first-cycle approvals, but GAO found cases where FDA’s comments were unclear and potentially hard to address. In this report, GAO makes recommendations to help FDA address those concerns.
  • On August 7, 2019, the Bipartisan Policy Center released a report entitled, Expanding the Use of Real-World Evidence in Regulatory and Value-Based Payment Decision-Making for Drugs and Biologics. The authors of this report examined electronic health care data sources and their potential applications in improving the evidence base for the development of new drugs and biologics, regulatory evaluation by the Food and Drug Administration (FDA), and new value-based payment arrangements, which align pricing or payments with outcomes. The recommendations made in the report “are expected to advance the generation and use of real-world evidence for regulatory evaluation and value-based payment decision-making.”

IV. Other Health Policy News

  • On August 5, 2019, the Centers for Medicare & Medicaid Services (CMS) released new guidance to states to promote proper use of prescription opioids by updating standard requirements for the Medicaid Drug Utilization Review (DUR) program. The Medicaid DUR program is a two-phase process that screens drug claims to help identify clinical misuse or abuse and examines claims data to identify patterns of abuse. More information about the DUR guidance is available here.
  • On August 7, 2019, CMS finalized the decision to cover FDA-approved Chimeric Antigen Receptor T-cell, or “CAR T-cell” therapy, which is a form of cancer treatment that uses a patient’s own genetically-modified immune cells to fight disease. Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia. A compendium is used in determining medically-accepted uses of drugs and biologicals. Information about CMS-approved compendia is available here.
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