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
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On March 13, 2018, the Food and Drug Administration (FDA) issued a rule entitled, Medical Devices: Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit. The FDA is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the counter (OTC) denture repair kits. These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. The FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act permitting the exemption of a device from the requirement to submit a 510(k).
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On March 13, 2018, the Health Resources and Services Administration (HRSA) issued a notice entitled, Proposed Changes to the Graduate Psychology Education Program. The Graduate Psychology Education (GPE) Program is authorized by section 756 of the Public Health Service Act and administered by HRSA. The program provides financial support to organizations and institutions that train doctoral-level psychologists. This notice seeks public comment to inform and guide policy and planning associated with the GPE Program.
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On March 14, 2018, the Department of Health and Human Services (HHS) issued a notice entitled, Request for Nominations: Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The HHS is soliciting nominations of individuals who are interested in being considered a voting member for appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. Nominations from qualified individuals who wish to be considered for appointment to this member category of the Advisory Council are currently being accepted.
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On March 15, 2018, the FDA issued a proposed rule entitled, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes. The FDA is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, the FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or non-addictive, using the best available science to determine a level that is appropriate for the protection of the public health. The FDA is using the term “non-addictive” in this document specifically in the context of a potentially non-addictive cigarette. The FDA acknowledges the highly addictive potential of nicotine itself depending upon the route of delivery. As discussed elsewhere in the document, questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or non-addictive for specific members or segments of the population. The FDA envisions the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers. The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM.
Event Notices
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March 19, 2018: The FDA announced a public workshop entitled, Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. The workshop will discuss how to individuals can submit patient experience data to the FDA. The workshop will inform the development of patient-focused drug development guidance.
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March 19, 2018: The FDA announced a public workshop entitled, Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings; Public Workshop. This workshop is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring rare disease stakeholders together to discuss the challenges associated with the development and regulatory decision-making for rare disease treatments and to also discuss promising study designs and analytical methods that can help overcome these challenges.
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March 20, 2018: The FDA announced a public meeting entitled, Promoting the Use of Complex Innovative Designs in Clinical Trials. The topic to be discussed is the use of complex innovative designs in clinical trials of drugs and biological products to inform regulatory decision making.
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March 21, 2018: the FDA announced a public meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Committee. The Committee will function as a medical device panel to provide advice and recommendations to the FDA on classification of devices. The Committee will also provide advice and recommendations to the FDA on research programs in the Office of Blood Research and Review.
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March 22, 2018: The FDA announced a meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The PAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia.
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March 27, 2018: The HHS announced two meetings for the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). The meetings will be an orientation session for the ACICBL members and identify potential topics to work on for 2018.
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March 26-27, 2018: The HHS announced the March meetings of the Physician-Focused Payment Model Technical Advisory Committee (PTAC) which will be held in Washington, DC. The link contains the dates of all 2018 PTAC meetings. The meetings will include voting and deliberations on proposals for physician- focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
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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.
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April 10, 2018: The Centers for Disease Control and Prevention (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.
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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.
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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.
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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.
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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.
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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.
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May 14-16, 2018: The Centers 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.
II. Congressional Legislation & Committee Action
U.S. Senate
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On March 15, 2018, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, Perspectives on the 340B Drug Discount Program. Witnesses present included: Bruce Siegel, MD, MPH, President and Chief Executive Officer, America’s Essential Hospitals; Lori M. Reilly, Executive Vice President, Policy, Research & Membership, Pharmaceutical Research and Manufacturers of America; Sue Veer, MBA, President and Chief Executive Officer, Carolina Health Centers, Inc.; and Joseph M. Hill III, MA, Director, Government Relations Division, American Society of Health-System Pharmacists.
House of Representatives
III. Reports, Studies, & Analyses
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On March 13, 2018, the Journal of the American Medical Association released a study entitled, Health Care Spending in the United States and Other High-Income Countries. The study found that the United States spent twice as much on health care and performed worse in many population health measures compared to other high-income countries. The study can be accessed here.
IV. Other Health Policy News
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On March 13, 2018, the House failed to pass H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (referred to as the ‘Right to Try’ bill) by a vote of 259-140. The bill can be accessed here.
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