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 4, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation. This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs), reviewed by the Center for Drug Evaluation and Research (CDER).
- On April 5, 2018, the FDA issued guidance entitled, Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.
- On April 6, 2018, the FDA issued guidance entitled, Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs. This draft guidance addresses FDA’s current thinking about the relevant age groups to study and how early in the drug development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD).
- On April 6, 2018, the Center for Medicare and Medicaid Services (CMS) issued a final rule entitled, Contract Year 2019 Policy and Technical Changes to Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, Medicare Prescription Drug Benefit Programs, and PACE Program. This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to reduce the number of beneficiaries who may potentially misuse or overdose on opioids while still having access to important treatment options; implement certain provisions of the 21st Century Cures Act; support innovative approaches to improve program quality, accessibility, and affordability; attempt to offer beneficiaries more choices and better care; attempt to improve the CMS customer experience and maintain high beneficiary satisfaction; address program integrity policies related to payments based on prescriber, provider and supplier status in MA, Medicare cost plan, Medicare Part D and the PACE programs; provide an update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.
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 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 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 April 3, 2018, CMS released its final report on the 2018 health insurance exchanges open enrollment period. The report found that 11.8 million consumers were selected or automatically re-enrolled in exchange plans in the 50 states, plus Washington, D.C.
IV. Other Health Policy News
- On April 2, 2018, CMS announced the Calendar Year (CY) 2019 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. The letter can be accessed here.
- On April 5-6, 2018, the Medicare Payment Advisory Commission (MedPAC) held their April meeting. The meeting agenda can be accessed here.