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 April 16, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Listing of Ingredients in Tobacco Products. The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act.
- On April 18, 2018, the FDA issued guidance entitled, Metered Dose Inhaler and Dry Powder Inhaler Drug Products -- Quality Considerations. The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (MDIs)) and inhalation powders (also known as dry powder inhalers (DPIs)). Although not explicitly discussed, some of the principles and recommendations provided in this guidance may be applicable to nasal delivery products as well. The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.
- On April 18, 2018, the Drug Enforcement Agency (DEA) issued a proposed rule entitled, Controlled Substances Quotas. The DEA is publishing this proposed rule to strengthen controls over diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances.
- On April 20, 2018, the FDA issued guidance entitled, Opioid Dependence: Developing Depot Buprenorphine Products for Treatment. This draft guidance addresses drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation).
Event Notices
- April 23, 2018: The FDA announced a public meeting of the Arthritis Advisory Committee. The committee will discuss the new drug application for baricitinib tablets submitted by Eli Lilly for the treatment of rheumatoid arthritis.
- April 23, 2018: The FDA announced a meeting of the Science Board to the Food and Drug Administration. The Science Board will hear a report from the Center for Biologics Evaluation and Research Program Subcommittee; hear about FDA’s Patient Affairs Initiative; and discuss how the FDA can leverage its existing tools and authorities.
- April 24-25, 2018: The FDA announced a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss the findings of a recent study and interpret the study to better understand the safety risks of a number of NSAIDs.
- May 3, 2018: The FDA announced a public meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee. The general function of the committees is to provide advice and recommendations for the FDA on regulatory issues.
- May 3, 2018: The Department of Health and Human Services (HHS) announced a public meeting of the National Vaccine Advisory Committee. The public meeting will be dedicated to the deliberation of various recommendations to the Director of the National Vaccine Program.
- May 9, 2018: The FDA announced a public workshop entitled, Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation. The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity when approving a product with a tissue agnostic indication.
- May 14-16, 2018: The Center for Medicare and Medicaid Services (CMS) announced the public meetings on the Healthcare Common Procedure Coding System (HCPCS) for 2018. The public meetings will cover CMS’ preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments.
- May 22, 2018: The FDA announced a public meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss the new drug application for buprenorphine sublingual spray that would treat moderate-to-severe acute pain.
- May 24, 2018: The FDA announced a public workshop entitled, FY 2018 Generic Drug Regulatory Science Initiatives. The purpose of the workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on the initiatives.
- June 25, 2018: The CMS announced the Annual Laboratory Public Meeting. The meeting will gather public input on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HSPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule for calendar year 2019.
- June 25-26, 2018: The FDA announced a public symposium to discuss scientific topics related to the regulation of biologics and to highlight science conducted at the Center for Biologics Evaluation and Research. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.
II. Congressional Legislation & Committee Action
U.S. Senate
- On April 17, 2018, the Senate Finance Committee held a hearing entitled, Tackling Opioid and Substance Use Disorders in Medicare, Medicaid, and Human Services Programs. Witnesses present included Brett Giroir, M.D., Admiral, Assistant Secretary for Health, Office of the Assistant Secretary for Health, Senior Advisor to the Secretary for Mental Health and Opioid Policy, Department of Health and Human Services; and Kimberly Brandt, Principal Deputy Administrator for Operations, Center for Medicare and Medicaid Services.
House of Representatives
- On April 17, 2018, the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, FY 2019 Budget – Food and Drug Administration. FDA Commissioner Scott Gottlieb was the only witness present.
- On April 18, 2018, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, FY 2019 Budget Health and Human Services Biodefense Activities. Witnesses present included Robert Kadlec, M.D., Assistant Secretary for Preparedness and Response, HHS; Anthony Fauci, M.D., Director of the National Institute of Allergy and Diseases, NIH; and Stephen Redd, M.D. (RADM, USPHS), Director, Office of Public Health Preparedness and Response, CDC.
III. Reports, Studies, & Analyses
- On April 18, 2018, the HHS Office of Inspector General (OIG) issued a report entitled, CMS’s Policies and Procedures Were Generally Effective in Ensuring That Prescription Drug Coverage Capitation Payments Were Not Made After the Beneficiaries’ Dates of Death. The HHS OIG found CMS had policies that were generally effective in ensuring that capitation payments to sponsors for Medicare Part D coverage were not made on behalf of deceased beneficiaries after the individuals’ dates of death. However, CMS did not identify and recoup all improper capitation payments. Specifically, as of March 7, 2017, CMS had not recouped $1.1 million associated with 65,398 separate capitation payments. The HHS OIG recommended that CMS utilize information within the report to recoup the $1.1 million in payments and continue to implement systems enhancements to identify, adjust, and recoup improper capitation payments.
IV. Other Health Policy News
- On April 19-20, 2018, the Medicaid and CHIP Payment and Access Commission (MACPAC) held their April meetings. MACPAC’s meeting agenda can be accessed here.