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 May 16, 2018, the Department of Health and Human Services (HHS) issued a notice entitled, Institutional Review Board Written Procedures: Guidance for Institutions and Institutional Review Boards. The guidance is intended for institutions and Institutional Review Boards (IRBs) responsible for review and oversight of human subject research under HHS and the Food and Drug Administration (FDA) regulations. The purpose of this guidance is to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures.
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On May 17, 2018, the FDA issued a final rule entitled, Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories. The FDA is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). The FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. The FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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On May 18, 2018, the FDA issued guidance entitled, Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry. This draft revised guidance is provided to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications.
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On May 18, 2018, the FDA issued a notice entitled, Final Determination Regarding Partially Hydrogenated Oils. Based on the available scientific evidence and the findings of expert scientific panels, the FDA made a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids (IP-TFA), are generally recognized as safe (GRAS) for any use in human food. In a declaratory order announcing FDA’s final determination, the FDA set a compliance date of June 18, 2018. The FDA is now extending the compliance date for certain uses of PHOs.
Event Notices
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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.
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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.
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May 30, 2018: The HHS announced a meeting for the Pain Management Best Practices Inter-Agency Task Force (Task Force). The Task Force will identify, review, and determine whether there are gaps or inconsistencies between best practices for pain management, including for chronic and acute pain.
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June 25, 2018: The Center for Medicare and Medicaid Services (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.
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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.
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July 9, 2018: The FDA announced a public meeting on “Patient-Focused Drug Development for Chronic Pain.” The meeting will provide patients with an opportunity to present FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments.
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July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
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August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
II. Congressional Legislation & Committee Action
U.S. Senate
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On May 15, 2018, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, Examining Oversight Reports on the 340B Drug Pricing Program. Witnesses included: Ann Maxwell, Assistance Inspector General for Evaluation and Inspections, Office of the Inspector General, Department of Health and Human Services and Debra Draper, Ph.D., Director, Health Care Team, Government Accountability Office.
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On May 16, 2018, Senate Appropriations Subcommittee on Homeland Security held a hearing entitled, Hearing to Review the Role of DHS in Stopping the Flow of Opioids & Other Dangerous Drugs. Witnesses included: Todd Owen, Executive Assistant Commission, Office of Field Operations, Customs and Border Protection; Derek Benner, Acting Executive Associate Director, Homeland Security Investigations Immigration and Customs Enforcement; Andre Hentz, Acting Deputy Under Secretary for Science and Technology, Department of Homeland Security.
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On May 17, 2018, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Hearing to Review the FY 2019 Budget Request for the National Institutes of Health. Witnesses included: Dr. Francis Collins, Director, National Institutes of Health; Dr. Norman Sharpless, Director, National Cancer Institute; Dr. Walter Koroshetz, Director, National Institute of Neurological Disorders and Stroke; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases; Dr. Richard Hodes, Director, National Institute on Aging; and Dr. Nara Volkow, Director, National Institute on Drug abuse.
House of Representatives
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On May 16, 2018, the House Ways and Means Committee held a markup entitled, Markup of Bills to Combat the Opioid Crisis. The Committee reported seven bills to the House floor for further consideration.
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On May 17, 2018, the House Energy and Commerce Committee held a markup entitled, Energy and Commerce Committee Vote on Opioids Legislation. The Committee considered 34 bills, 32 of which were reported favorably to the House floor.
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On May 17, 2018, the House Oversight and Government Reform Committee held a hearing entitled, A Sustainable Solution to the Evolving Opioid Crisis: Revitalizing the Office of National Drug Control Policy. Witnesses included: The Honorable Senator John Cornyn (R-TX); Dr. Anand Parekh, Chief Medical Advisor, Bipartisan Policy Center; Dr. Rahul Gupta, Commissioner and State Health Officer, Department of Health and Human Resources’ Bureau for Public Health; Thomas Carr, Executive Director, Washington/Baltimore High Intensity Drug Trafficking Areas Program; Gretta Goodwin, Director, Homeland Security and Justice, U.S. Government Accountability Office.
III. Reports, Studies, & Analyses
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On May 15, 2018, the Government Accountability Office (GAO) issued a report entitled, Drug Discount Program: Status of Agency Efforts to Improve 340B Program Oversight. In September 2011, the GAO issued a report finding that the Health Resources and Services Administration’s (HRSA) oversight of the 340B program was inadequate to ensure compliance with program rules, and GAO recommended actions that HRSA should take to improve program integrity. Among other things, this report describes HRSA actions in response to GAO recommendations to improve its program oversight.
IV. Other Health Policy News
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On May 15, 2018, CMS released a redesigned version of the Drug Spending Dashboards, which include year-over-year information on drug pricing. Further information is available here.
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