Alston & Bird Healthcare Week in Review, December 15, 2017

I. Regulations, Notices, & Guidance

• On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for product name placement, size, and prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including biological products as well as animal drugs.
• On December 11, 2017, the FDA issued a notice entitled, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion. The notice announces proposed projects to help the Office of Prescription Drug Promotion (OPDP) within the FDA ensure that prescription promotion is truthful, balanced, and accurately communicated. The research will focus on the ability of consumers and healthcare professionals to identify deceptive prescription drug promotion.
• On December 12, 2017, the FDA issued a notice entitled, Orphan Products Development; Food and Drug Administration Orphan Drug Designation Request Form and The Common European Medicines Agency/Food and Drug Administration Form for Orphan Medicinal Product Designation (Formerly Orphan Drugs; Common European Medicines Agency/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671)). The FDA announced a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. The FDA is requesting information to provide a basis for a determination that a specific drug is for a rare disease or condition and satisfies the requirements for obtaining orphan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers.
• On December 13, 2017, the FDA issued a guidance entitled, Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals. The FDA announced an opportunity for public comment on the proposed collection of certain information per the Paperwork Reduction Act. The notice solicits comments on the information collection processes for the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.
• On December 13, 2017, the Center for Medicare & Medicaid Services (CMS) issued a final rule with comment period entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. This rule was originally published in the Federal Register on November 13, 2017, however, a section was omitted due to a printing error. The rule is published here in its entirety. The rule revises Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018. The CMS describes changes in the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and ASC systems. In addition, the final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. The rule is effective on January 1, 2018. Comments are due on December 31, 2017.
• On December 14, 2017, the FDA issued a draft guidance entitled, The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. The FDA utilizes a least burdensome approach for medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This guidance describes the guiding principles and recommended approach for FDA staff and industry to apply the least burdensome principles.
• On December 15, 2017, the Center for Disease Control and Prevention (CDC) issued a notice entitled, Invitation to Manufacturers of Pertussis Serological Kits. The document invites commercial manufacturers to work with CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) on the validation of pertussis serological kits prior to submission to the FDA for market authorization. The CDC is interested in development of an assay that is an Immunoglobulin G (IgG) anti-pertussis toxin enzyme-linked immunosorbent assay (ELISA), calibrated to an international reference standard. The ELISA will be used for in vitro serological diagnosis of pertussis in clinical cases of selected age groups. The CDC will provide guidance, materials, and evaluation support for the manufacturer. However, the manufacturer will be responsible for submitting a premarket submission to the FDA.
• On December 15, 2017, the FDA issued a draft guidance entitled, Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease. The guidance describes the FDA’s current recommendations on how to group patients with different molecular alterations for eligibility in clinical trials and general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.

• December 15, 2017: The FDA announced a public workshop entitled, Medical Gas Regulation Workshop I. The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
• December 18, 2017: The FDA announced a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA may be used to inform regulatory decision making. This workshop will inform development of patient-focused drug development guidance as required by the 21^st Century Cures Act.
• December 18-20, 2017: The Department of Health and Human Services (HHS) announced the next meeting of the Physician-Focused Payment Model Technical Advisory Committee which will be held in Washington, D.C. The meeting 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.
• January 9-10, 2018: The HHS announced a meeting of the National Committee on Vital and Health Statistics (Committee). Committee members will discuss several health data policy topics and begin work outlined in their 2018 work plan. In addition, an environmental scan report will be reviewed and discussed by the Committee as art of the Health Information Privacy and Security Beyond HIPAA project.
• January 10, 2018: The FDA announced a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the agency on FDA’s regulatory issues. The meeting will be open to the public.
• January 11-12, 2018: The CDC announced a public meeting for the Board of Scientific Counselors (BSC) and the National Center for Health Statistics (BSC, NCHS). The meeting will provide an update on the National Health and Nutrition Examination Survey Reports and activities; provide an update on the Division of Health Care Statistics Reports and Activities; provide an update on vital statistics activities; and an update on the international activities of the NCHS.
• January 24, 2018: The FDA announced a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the TPSAC is to provide advice and recommendations to the FDA’s regulatory issues. The TPSAC will discuss modified risk tobacco product applications submitted by tobacco companies. The FDA intends to make background material available to the public no later than two business days before the meeting.
• January 24, 2018: The NIH announced a meeting to review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The RoC is a congressionally mandated report that identifies agents, substances, mixtures, or exposures in the environment that pose a cancer hazard for people in the United States.
• January 24, 2018: The HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The Advisory Council provides advice, information, and recommendations to the Secretary of HHS. The Advisory Council will meet to discuss strategies to combat antibiotic-resistant bacteria.
• January 25, 2018: The FDA announced a public hearing on FDA’s approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including appropriate use and labeling.
• January 30, 2018: The FDA announced a public hearing entitled, Opioid Policy Steering Committee: Prescribing Intervention –Exploring a Strategy for Implementation. The purpose of the hearing is to receive stakeholder input on how the FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing and limit abuse of opioid analgesics.
• February 13, 2018: The CMS announced a Town Hall meeting to discuss fiscal year (FY) 2019 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to the meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.
• February 9, 2018: The FDA announced a public workshop entitled, Medical gas Regulation Workshop II. The topic to be discussed is potential areas of federal drug regulation that should be revised with respect to medical gases.
• 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 individuals can submit patient experience data to the FDA. The workshop will inform the development of patient-focused drug development guidance.

II. Congressional Legislation & Committee Action

• On December 12, 2017, the Senate Judiciary Committee held a hearing entitled, Oversight of the Ensuring Patient Access and Effective Drug Enforcement Act. The witnesses present included: Demetra Ashley, Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration; Jan Favero Chambers, President, National Fibromyalgia & Chronic Pain Association; The Honorable Brian Frosh, Attorney General, State of Maryland; Carmen Catizone, M.D., Executive Director, National Association of Board of Pharmacy; John Gray, President and CEO, Healthcare Distribution Alliance.
• On December 12, 2017 the Senate HELP Committee held a hearing entitled, The Cost of Prescription Drugs: An Examination of The National Academies of Sciences, Engineering, and Medicine Report “Making Medicines Affordable: A National Imperative.” The witnesses present included: Norm Augustine, Chair of Committee on Ensuring Patient Access to Affordable Drug Therapies National Academies of Sciences, Engineering and Medicine; David Mitchell, President and Founder, Patients for Affordable Drugs; Douglas Holtz-Eakin, M.D., President, American Action Forum.
• On December 13, 2017, the Senate HELP Committee held a hearing entitled, Implementation of the 21^st Century Cures Act: Responding to Mental Health Needs. The witness present was Elinor McCance-Katz, M.D., Ph.D., Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration (SAMHSA).

• On December 12, 2017, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Examining Concerns of Patient Brokering and Addiction Treatment Fraud. Witnesses present included: Dave Aronberg, State Attorney, 15^th Judicial Circuit; Eric Gold, Assistant Attorney General, Health Care Division, Office of the Massachusetts Attorney General; Alan Johnson, Chief Assistant State Attorney, 15^th Judicial Circuit; Pete Nielsen, Chief Executive Officer, California Consortium of Addiction Programs and Professionals; Douglas Tieman, President and CEO, Caron Treatment Centers.
• On December 13, 2017, The House Energy and Commerce Subcommittee on Health held a hearing entitled, Examining the Drug Supply Chain. The witnesses present included: Chip Davis, President and CEO, Association for Accessible Medicines; Tom DiLenge, President, Advocacy, Law, and Public Policy, Biotechnology Innovation Organization; Matt Eyles, Senior Executive Vice President and Chief Operating Officer for Policy and Regulatory Affairs, America’s Health Insurance Plans; Elizabeth Gallenagh, Senior Vice President, Government Affairs and General Counsel, Health Care Distribution Alliance; Gerald Harmon, M.D., Chair, Board of Trustees, American Medical Association; B. Douglas Hoey, CEO, National Community Pharmacists Association; Mark Merritt, President and CEO, Pharmaceutical Care Management Association; David Mitchell, Founder and President, Patients for Affordable Drugs; Tom Nickels, Executive Vice President for Government Relations and Public Policy, American Hospital Association; Lori Reilly, Executive Vice President for Policy, Research and Membership, Pharmaceutical Research and Manufacturers of America

• On December 14, 2017, the Government Accountability Office (GAO) issued a report entitled, Health Insurance Exchanges: Changes in Benchmark Plans and Premiums and Effects of automatic Re-enrollment on Consumers’ Costs. In the report, GAO studied nearly 2,600 counties and found the plans identified as benchmark plans, and the premiums for these plans, changed from year to year. Further, the report found that gross benchmark premiums increased from year to year, and the increases were higher from 2016 to 2017 than they were from 2015 to 2016.

1. Other Health Policy News

• On December 14, 2017, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) held their December meeting. MACPAC’s agenda can be found here.