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 March 26, 2018, the Food and Drug Administration (FDA) issued a noticed entitled, Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee. The FDA is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (Committee), Division of Advisory Committee Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. The FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
- On March 28, 2018, the FDA issued guidance entitled, Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability. The FDA is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled “Product-Specific Guidance for Doxycycline Hyclate.” The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for doxycycline hyclate oral delayed-release tablets.
- On March 30, 2018, the FDA issued a notice entitled, Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan; Request for Comments. The FDA is announcing the availability of a draft 5-year plan describing the FDA’s approach to further the implementation of structured benefit-risk assessment, including the incorporation of the patient’s voice in drug development and decision-making, in the human drug review program and the opportunity for public comment on the draft plan.
- On March 30, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities which Meet Minimum Standards to Engage in Urine Drug Testing for Federal Agencies. This notice lists all certified laboratories and Instrumental Initial Testing Facilities (IITF) to administer Federal workplace drug testing programs.
Event Notices
- April 6, 2018: The FDA announced a public meeting entitled, S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Humans Use (ICH). The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Kobe, Japan. The topics to be address at the meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly meeting in Kobe, Japan.
- April 10, 2018: The CDC announced a meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will focus on the clinical laboratory workforce; implementation of next generation sequencing in clinical laboratories; laboratory interoperability; and using clinical laboratory data to improve quality and laboratory medicine practices.
- April 16, 2018: The FDA announced a public meeting entitled, Evaluating Inclusion and Exclusion Criteria in Clinical Trials. The purpose of the meeting is to bring together stakeholders to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.
- April 17, 2018: The FDA announced a public meeting entitled, Patient-Focused Drug Development in Opioid Use Disorder. The purpose of the meeting is to obtain patients’ perspectives on treatment approaches for opioid use disorder. The meeting is part of FDA’s ongoing work aimed at reducing the impact of opioid abuse and addiction.
- April 16-18, 2018: the HRSA announced a public meeting of the National Advisory Committee on Rural Health and Human Services. During the meeting the Committee will examine the issues of Assessing and Mitigating the Effect of Adverse Childhood Experiences and Health Insurance Markets in Rural Areas; conduct site visits to the Adirondack Health Institute in Glens Falls, New York and St. Vincent de Paul Catholic Church in Cobleskill, New York, to visit the Head Start Program; and summarize key findings and develop a work plan for the next quarter.
- April 19, 2018: The FDA announced a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The Committee provides advice and recommendations to FDA on regulatory issues. The Committee will discuss new drug application 210365, cannabidiol oral solution, sponsored by GW pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
- 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 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 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
- No health-related hearings this week.
House of Representatives
- No health-related hearings this week.
III. Reports, Studies, & Analyses
- On March 29, 2018, Avalere published an analysis on the performance of accountable care organizations (ACOs). According to Avalere, the Congressional Budget Office projected a $1.7 billion in net savings for the federal government from ACOs, but federal spending has increased by $348 million since 2010.
IV. Other Health Policy News
- On March 26-27, the Physician-Focused Payment Model Technical Advisory Committee (PTAC) held its March meeting. PTAC’s March meeting agenda can be accessed here.