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 February 26, 2018, the Food and Drug Administration (FDA) issued a final order entitled, Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test. The FDA is classifying Lynch syndrome test systems into class II (special controls). The special controls that apply to the device type are identified in the order and will be part of the codified language for the Lynch syndrome test systems’ classification. The FDA is taking this action because they have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. The FDA also believes this action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
- On February 27, 2018, the Health Resources and Services Administration (HRSA) issued a notice entitled, Women’s Preventative Services Guidelines. Applicable as of December 29, 2017, HRSA updated the Women's Preventive Services Guidelines for purposes of health insurance coverage for preventive services that address health needs specific to women based on clinical recommendations from the Women's Preventive Services Initiative. This 2017 update adds two additional services - Screening for Diabetes Mellitus after Pregnancy and Screening for Urinary Incontinence – to the nine preventive services included in the 2016 update to the HRSA supported Women’s Preventive Services Guidelines. The nine services included in the 2016 update are as follows: Breast Cancer Screening for Average Risk Women, Breastfeeding Services and Supplies, Screening for Cervical Cancer, Contraception, Screening for Gestational Diabetes Mellitus, Screening for Human Immunodeficiency Virus Infection, Screening for Interpersonal and Domestic Violence, Counseling for Sexually Transmitted Infections, and Well-Woman Preventive Visits. This notice serves as an announcement of the decision to update the document.
- On February 28, 2018, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Request for Information Regarding Patient-Reported Outcome Measures. The AHRQ is seeking information submissions from the public. Information is being solicited to inform AHRQ’s work on patient-reported outcomes (PROs). Access to information regarding physical function PRO measure use will assist the selection of measures for AHRQ’s efforts to develop and implement user-friendly technical tools to collect and integrate PRO data in electronic health records or other health information technology products.
- On March 1, 2018, the FDA issued guidance entitled, Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act. The FDA is announcing the availability of a draft guidance entitled “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.” The draft guidance is intended to describe FDA’s interpretation of terms used in the definitions of “suspect product” and “illegitimate product” in the Drug Supply Chain Security Act (DSCSA), for purposes of trading partners’ verification obligations (including notification). The draft guidance lays out FDA’s current understanding of the following key terms: counterfeit, diverted, fraudulent transaction, and unfit for distribution.
- February 28, 2018: The HHS announced the next meeting of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. The meeting will be held online via webinar and is open to the public. The Committee will discuss the nation’s health status and health risk goals for the nation by the year 2030.
- March 1, 2018: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). VRBPAC will meet in open session to hear an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), CBER, FDA. Also the committee discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2018-2019 influenza season. FDA intends to make background material available to the public no later than 2 business days before the meeting.
- March 2, 2018: The HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Council). The meeting will be dedicated to the Council’s deliberation and vote on a letter drafted by the Immediate Action subcommittee. The meeting agenda will be posted on the council’s website at http://www.hhs.gov/ash/carb/ when it has been finalized.
- March 6, 2018: The CDC’s National Center for Health Statistics announced a meeting of the ICD-10 Coordination and Maintenance Committee. The Committee will discuss many coding topics specified in the link. The meeting is open to the public and will be broadcast live via webcast.
- March 8, 2018: The HHS announced an upcoming meeting of the Advisory Commission on Childhood Vaccines (ACCV). The meeting will be open to the public. The meeting agenda will include, but not limited to, updates from the Department of Justice, National Vaccine Program Office, Immunization Safety Office, and Center for Biologics. A draft agenda will be posted on the ACCV website prior to the meeting.
- March 8, 2018: The FDA announced an upcoming public meeting of the Gastrointestinal Drugs Advisory Committee. The general function of the Committee is to provide advice and recommendations to the FDA on regulatory issues. The Committee will discuss supplemental new drug applications (sNDA) 203214 supplement 18, XELJANZ tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitor therapy.
- March 13-14, 2018: The HHS announced a meeting of the Advisory Committee on Human Research Protections. The meetings will cover various topics pertaining to or associated with the protection of human research subjects.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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 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.
- 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 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
- On February 27, 2018, Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, The Opioid Crisis: The Role of Technology and Data in Preventing and Treating Addiction. Witnesses present included: Snezana Mahon, PharmD, Vice President, Clinical Product Development, Express Scripts; Sherry L. Green, Esq., Chief Executive Officer, Sherry L. Green & Associates, LLC, Co-Founder, National Alliance for Model State Drug Laws (NAMSDL); H. Westley Clark, MD, JD, MPH, Dean’s Executive Professor, Public Health Program, Santa Clara University; and Sanket Shah, Clinical Assistant Professor, Health Informatics, University of Illinois at Chicago.
House of Representatives
- On February 27, 2018, the House Judiciary Committee Subcommittee on Regulatory Reform, Commercial and Antitrust Law held a hearing entitled, Competition in the Pharmaceutical Supply Chain: The Proposed Merger of CVS Health and Aetna. Witnesses present included: Thomas Moriarty, Executive Vice President, Chief Policy and External Affairs Officer, General Counsel, CVS Health; Thomas Sabatino, Jr., Executive Vice President, General Counsel, Aetna, Inc.; Craig Garthwaite, PhD, Associate Professor of Strategy, Director, Health Enterprise Management Program, Kellogg School of Management, Northwestern University; Lawrence Wu, PhD, President, National Economic Research Associates Economic Consulting (NERA); George Slover, Senior Policy Council, Consumer Union (CU); Geoffrey Manne, Executive Director, International Center for Law and Economics (ICLE).
- On February 28, 2018, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety. Witnesses present included: Susan A. Gibson, Deputy Assistant Attorney, Diversion Control Division, Drug Enforcement Administration (DEA); Frank L. Fowler, Chief of Police, Syracuse Police Department (SPD); Patrick M. Beardsley PhD, Professor, Department of Pharmacology and Toxicology, Virginia Commonwealth University (VCU); Ponni Subbiah, MD, Chief Medical Officer, Indivior PLC; John Mulder, MD, Director, Trillium Institute; David Y. Kan, MD, President, California Society of Addiction Medicine (CSAM); Richard J. Nance, Director, Utah County Department of Drug and Alcohol Prevention and Treatment (UCDDAPT); Thomas J. Cosgrove, Partner, Covington and Burling LLP; Andrew Kolodny, MD, Co-Director, Opioid Policy Research, Brandeis University; and Richard N. Logan, PharmD, Owner, L&S Pharmacy.
III. Reports, Studies, & Analyses
- On March 1, 2018, the Kaiser Family Foundation released findings from a recent health-care related poll. The poll found that a plurality of all voters – 22 percent – rank health care costs as the most important health care-related issue.
IV. Other Health Policy News