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 September 10, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Post-Approval Changes to Drug Substances; Draft Guidance for Industry; Availability. This draft guidance provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application post-approval period. The draft guidance applies to synthetic drug substances and the synthetic steps involved in the preparation of semisynthetic drug substances. The draft guidance covers facility, scale, and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, raw materials, intermediates, and the unfinished and final drug substance; synthetic manufacturing process changes; changes in the source of drug substance; and change to container closure system of the drug substance.
• On September 12, 2018, the FDA issued a proposed rule entitled, Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format. The FDA is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. If finalized, this action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA’s premarket submission program for medical devices. This action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the FDA to achieve their public health mission and fulfill statutory obligations.
• On September 13, 2018, the FDA issued guidance entitled, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. Voluntary consensus standards can be a valuable resource for industry and FDA staff because such standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. FDA developed this document to provide guidance to industry and FDA reviewers about the appropriate use of voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. This guidance applies to all articles that meet the definition of a "device" under the Federal Food, Drug, and Cosmetic Act (FD&C Act).   
• On September 13, 2018, the FDA issued guidance entitled, 510(k) Third-Party Review Program. This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third-Party (3P) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to issue draft guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P Review Program is intended to allow review of devices by 3P Review Organizations to provide manufacturers of these devices an alternative review process that allows FDA to best utilize resources on higher risk devices. This draft guidance is not final nor is it in effect at this time.

Event Notices   

• September 20, 2018: The FDA announced a public meeting entitled, Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care. The meeting is intended to generate discussion with providers and health system stakeholders on the armamentarium of medications to treat opioid use disorder, current barriers to appropriate use of these medications, opportunities to reduce stigma, and methods to expand access to effective pharmacotherapies.
• September 25-26, 2018: The FDA announced a public meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will discuss updates to existing best practices and recommendations based on gaps and inconsistencies for pain management, including chronic and acute pain.
• September 28, 2018: The FDA announced a conference entitled, Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery – Influences of Sex and Gender. The purpose of the conference is to discuss the biological and sociological influences on misuse, abuse, and cessation of opioids and tobacco.
• October 27, 2018: The FDA announced a public meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general functions of the committees is to provide advice and recommendations to the FDA on regulatory issues.
• November 5, 2018: The FDA announced a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in the above notice and associated web content that will be published before the hearing.
• November 27, 2018: The FDA announced a public meeting entitled, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The purpose of the hearing is to give stakeholders the opportunity to provide input on the underlying systemic causes of drug shortages and make recommendations for actions to prevent or mitigate drug shortages.

II. Congressional Legislation & Committee Action

U.S. Senate

• No health-related hearings this week.

House of Representatives

• On September 13, 2018, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Examining Barriers to Expanding Innovative, Value-based Care in Medicare. Witnesses present included: Michael Robertson, M.D., Chief Medical Officer, Covenant Health Partners;  Michael Weinstein, M.D., President, Digestive Health Physicians Association; Morgan Reed, President, The App Association; Nishant Anand, M.D., Chief Medical Officer, Adventist Health System; Timothy Peck, M.D., CEO, Call9; and Mary Grealy, President, Healthcare Leadership Council.
• On September 13, 2018, the House Energy and Commerce Committee held a markup on a number of health-related bills. All bills were passed by a voice vote. Legislation included: H.R. 3325, Advancing Care for Exceptional (ACE) Kids Act; H.R. 3891, To amend title XIX of the Social Security Act to clarify the authority of State Medicaid fraud and abuse control units to investigate and prosecute cases of Medicaid patient abuse and neglect in any setting, and for other purposes; H.R. 5306, Ensuring Medicaid Provides Opportunities for Widespread Equity, Resources, and (EMPOWER) Care Act; H.R. 6733, To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to prohibit group health plans, health insurance issuers, prescription drug plan sponsors, and Medicare Advantage organizations from limiting certain information on drug prices; and H.R. 6753, To amend title XI of the Social Security Act to direct the Secretary of Health and Human Services to establish a public-private partnership for purposes of identifying health care waste, fraud, and abuse.

III. Reports, Studies, & Analyses

• On September 13, 2018, the West Institute and NORC at the University of Chicago issued a report entitled, What Should Be Done About The High Cost of Prescription Drugs. According to the report, seventy-seven percent of Americans regard the cost of prescription medication as unreasonable and few Americans approve of how President Trump and Congress are handling the issue.

IV. Other Health Policy News

On September 12, 2018, the FDA took steps to address youth e-cigarette use by requesting manufacturers to provide a plan for mitigating youth sales within 60 days. More information is available here.

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