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 September 5, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Development of Human Gene Therapy Products. The FDA is extending the comment period for the notices of availability for six draft guidance documents relating to the development of human gene therapy products that appeared in the Federal Register of July 12, 2018. The FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments and any new information.
- On September 5, 2018, the FDA issued a notice entitled, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the FDA. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the identification of a suspect product and the termination of notifications regarding an illegitimate product.
- On September 5, 2018, the Center for Disease Control and Prevention (CDC) issued a notice entitled, Surgeon General’s Call to Action: “Community Health and Prosperity.” The CDC announced the opening of a docket to obtain comment on an upcoming Surgeon General’s call to action with a working title “Community Health and Prosperity.” The CDC is the lead agency to support the Office of the Surgeon General to publish a call to action that will be science informed and actionable, outlining a conceptual framework with case examples and available evidence on the business case for investing in community health. The goal of the call to action is to: clearly demonstrate that investments in community health have the potential to improve the health and prosperity of communities and issue a call to action to the private sector and local policy makers for investment in communities, unilaterally or as part of multi-sector or other consortium, to improve community health.
- On September 7, 2018, the FDA issued a notice entitled, Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the States and the Food and Drug Administration; Revised Draft; Availability. This revised draft Memorandum of Understanding (MOU) describes the responsibilities of a State that chooses to sign an MOU in investigating and responding to complaints related to compounded drug products compounded in the State and distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded drug products.
Event Notices
- September 10-11, 2018: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD will discuss oral health training programs and finalize its recommendations on funding and appropriate levels to be included in its report.
- September 12, 2018: The FDA announced a public hearing to solicit comments on FDA’s Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review.
- September 12, 2018: The FDA announced a public meeting of the Pharmacy Compounding Advisory Committee (PCAC). The PCAC will receive information on balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements.
- September 20, 2018: The FDA announced a public meeting entitled, Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care. The meeting is intended to generate discussion with providers and health system stakeholders on the armamentarium of medications to treat opioid use disorder, current barriers to appropriate use of these medications, opportunities to reduce stigma, and methods to expand access to effective pharmacotherapies.
- September 25-26, 2018: The FDA announced a public meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will discuss updates to existing best practices and recommendations based on gaps and inconsistencies for pain management, including chronic and acute pain.
- September 28, 2018: The FDA announced a conference entitled, Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery – Influences of Sex and Gender. The purpose of the conference is to discuss the biological and sociological influences on misuse, abuse, and cessation of opioids and tobacco.
- November 5, 2018: The FDA announced a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in the above notice and associated web content that will be published before the hearing.
- November 27, 2018: The FDA announced a public meeting entitled, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The purpose of the hearing is to give stakeholders the opportunity to provide input on the underlying systemic causes of drug shortages and make recommendations for actions to prevent or mitigate drug shortages.
II. Congressional Legislation & Committee Action
U.S. Senate
- No health-related hearings this week.
House of Representatives
- On September 5, 2018, the House Ways and Means Committee passed four health-related bills, including H.R. 6662, Empowering Seniors’ Enrollment Decision Act of 2018; H.R. 6690, Fighting Fraud to Protect Care for Seniors Act of 2018; H.R. 6561, Comprehensive Care for Seniors Act of 2018; and H.R. 3635, Local Coverage Determination Clarification Act of 2017. Additional information on the legislation is available here.
- On September 5, 2018, the House Energy and Commerce Subcommittee on health held a hearing entitled, Opportunities to Improve Health Care. Witnesses included: Hugh Chancy, Owner, Chancy Drugs, Hahira, Georgia, and Member of the Board of Directors, National Community Pharmacists Association; Curtis Cunningham, Vice President, National Association of States United for Aging and Disabilities and Assistant Administrator, Long-Term Care Benefits and Programs, Department of Health and Human Services, State of Wisconsin; Rick Merrill, President and Chief Executive Officer, Cook Children’s Health Care System, Fort Worth, Texas; Matt Salo, Executive Director, National Association of Medicaid Directors; Derek Schmidt, Attorney General, State of Kansas; and David Yoder, Pharm. D., Executive Director of Member Care and Benefits, Blue Cross Blue Shield Association’s Federal Employee Plan.
- On September 5, 2018, the House Veterans Affairs Committee held a hearing entitled, Reusable Medical Equipment: Continuing to Examine VHA's Sterile Processing Problems. Witnesses present included Teresa Boyd, D.O., Assistant Under Secretary for Health for Clinical Operations, Department of Veterans Affairs; Sharon Silas, Government Accountability Office (GAO); John Daigh, M.D., Assistant Inspector General for Healthcare Inspections.
- On September 6, 2018, the House Energy and Commerce Committee held a hearing entitled, Examining Federal Efforts to Ensure Quality of Care and Resident Safety in Nursing Homes. Witnesses present included John Dicken, Director, GAO; Ruth Ann Dorrill, Regional Inspector General, Office of Inspector General, Department of Health and Human Services. Kate Goodrich, M.D., Director, Center for Clinical Standards and Quality, and Chief Medical Officer, Centers for Medicare and Medicaid Services.
- On September 7, 2018, the House Energy and Commerce Committee held a markup on a number of health related bills and discussion drafts. The bills considered included: H.R. 3325, Advancing Care for Exceptional (ACE) Kids Act; H.R. 3891, To amend title XIX of the Social Security Act to clarify the authority of State Medicaid fraud and abuse control units; H.R. 5306, Ensuring Medicaid Provides Opportunities for Widespread Equity, Resources, and (EMPOWER) Care Act; H.R. __, Strengthening the Health Care Fraud Prevention Task Force Act of 2018; H.R. __, To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to prohibit; H.R. __, To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission.
III. Reports, Studies, & Analyses
- On September 5, 2018, Wells Fargo issued their August 2018 Drug Pricing Report. The report found that, across all drug manufacturers, 60 products increased in price, while 48 products decreased in price. Additional information is available here.
IV. Other Health Policy News
- On September 6-7, 2018, the Medicare Payment Advisory Commission (MedPAC) held their September meetings. MedPAC’s September agenda is available here.