Alston & Bird Health Care Week in Review, September 20, 2019

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

On September 19, 2019, House Speaker Nancy Pelosi (D-CA) released the text of her drug-pricing bill. The bill is similar to the draft that was leaked last week; however, the updated bill directs the HHS Secretary to negotiate prices on drugs without generic or biosimilar competition while the earlier draft called for third-party price negotiation on drugs with less than two competing generics or biosimilars. More information about the bill can be found below.

I. Regulations, Notices, & Guidance

• On September 16, 2019, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance. The DEA proposes to designate the precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) as an immediate precursor for the schedule II controlled substance fentanyl. Furthermore, the DEA proposes to control norfentanyl as a schedule II substance under the Controlled Substances Act (CSA). Norfentanyl is the immediate chemical intermediary in a synthesis process currently used by clandestine laboratory operators for the illicit manufacture of the schedule II controlled substance fentanyl. The distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years. The DEA believes that the control of norfentanyl as a schedule II controlled substance is necessary to prevent its diversion as an immediate chemical intermediary for the illicit production of fentanyl.
• On September 16, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Product-Specific Guidances. The FDA is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance.
• On September 18, 2019, FDA issued guidance entitled, Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act. This guidance provides FDA’s current thinking on what constitutes a 505(q) petition and describes some of the considerations that FDA will take into account in determining whether a petition is submitted with the primary purpose of delaying the approval of an application. This guidance finalizes the draft guidance for industry entitled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act" issued in October 2018.
• On September 18, 2019, FDA issued guidance entitled, Safer Technologies Program for Medical Devices. This draft guidance describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k)). Consistent with the FDA's statutory mission to protect and promote public health, FDA believes that this "Safer Technologies Program" or "STeP" will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance. This draft guidance is not final nor is it in effect at this time.
• On September 19, 2019, FDA issued guidance entitled, Safety and Performance Based Pathway Device-Specific Guidance. The FDA is announcing the availability of several device-specific draft guidance documents for the Safety and Performance Based Pathway—specifically, "Spinal Plating Systems--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff"; "Cutaneous Electrode for Recording Purposes--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff"; "Conventional Foley Catheters--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff"; and "Orthopedic Non-Spinal Metallic Bone Screws and Washers--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff." These device-specific draft guidances were developed in accordance with the finalized guidance entitled "Safety and Performance Based Pathway." These draft guidances are not final nor are they in effect at this time.
• On September 20, 2019, FDA issued a proposed rule entitled, Premarket Tobacco Product Applications and Recordkeeping Requirements. This proposed rule would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally marketed. The proposed rule would help to ensure that PMTAs contain sufficient information for FDA to determine whether a marketing order should be issued for a new tobacco product, including detailed information regarding the physical aspects of a tobacco product, as well as full reports of information to demonstrate the scope of, and details regarding, investigations that may show the potential health risks of the product. The proposed rule would codify the general procedures FDA would follow when evaluating PMTAs, including application acceptance, application filing, and inspections, and would also create postmarket reporting requirements for applicants that receive marketing orders. The proposed rule would allow for the submission of PMTAs in alternative formats in certain instances to reduce the burden of submitting a PMTA for modifications to a product that previously received a PMTA marketing order or resubmitting a PMTA to address deficiencies specified in a no marketing order. The proposed rule would also require tobacco product manufacturers to keep records regarding the legal marketing of certain tobacco products without a PMTA, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
• On September 20, 2019, FDA issued guidance entitled, Interacting with the Food and Drug Administration on Complex Innovative Clinical Trial Designs for Drugs and Biological Products. This draft guidance provides recommendations to sponsors and applicants on interacting with the FDA on complex innovative clinical trial design proposals for drugs or biological products. In accordance with the mandate under the 21st Century Cures Act, the draft guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review.
• On September 20, 2019, FDA issued guidance entitled, The Accreditation Scheme for Conformity Assessment Pilot Program. The Pilot Accreditation Scheme for Conformity Assessment Program (or ASCA Pilot) is authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In accordance with amendments made to the FD&C Act by the FDA Reauthorization Act of 2017 (FDARA) and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA was directed to issue a draft guidance regarding the goals and implementation of the ASCA Pilot. The establishment of the goals, scope, procedures, and a suitable framework for the voluntary ASCA Pilot supports the Agency’s continued efforts to use its scientific resources effectively to protect and promote public health by simplifying certain aspects of premarket review, thereby reducing burdens on the Agency for individual submissions. FDA believes the voluntary ASCA Pilot may further encourage international harmonization of medical device regulation because it incorporates elements, where appropriate, from a well-established set of international conformity assessment practices and standards. The voluntary ASCA Pilot does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions. This draft guidance is not final nor is it in effect at this time.

Event Notices         

• September 24, 2019: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Advisory Committee on Heritable Disorders in Newborns and Children. During this meeting, the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a discussion of the role of health information technology within state newborn screening programs and general updates on ACHDNC projects focused on newborn screening.
• September 26, 2019: FDA announced a public meeting entitled, Joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. During the meeting, committee members will discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by the Food and Drug Administration Safety and Innovation Act, and to discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana IR as an example.
• September 26, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Substance Abuse and Mental Health Services Administration’s National Advisory Council. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion with SAMHSA NAC members.
• September 27, 2019: The Department of Health and Human Services (HHS) announced a public meeting entitled, National Clinical Care Commission. The National Clinical Care Commission (the Commission) is charged to evaluate and make recommendations to HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases. This virtual meeting will consist of an update on the Data Call to federal agencies and Commission discussion on key topics for secondary research in support of the Report to Congress.
• September 27, 2019: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The topics to be discussed during this meeting will include strategies to address HIV-related health disparities among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform the Office of Minority Health (OMH) and the Office of Infectious Disease and HIV/AIDS Policy of efforts related to the Federal Ending the HIV Epidemic Initiative.
• October 2, 2019: HHS announced a public meeting entitled, Meeting of the Secretary’s Advisory Committee on 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 proposed health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will discuss the role of data partnerships and deliberate recommendations for establishing data partnerships for implementing and achieving the Healthy People 2030 objectives. Pursuant to the Committee’s charter, the Committee’s advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
• October 11, 2019: HRSA announced a public meeting entitled, Advisory Committee on Interdisciplinary, Community-Based Linkages. The Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning activities under sections 750 – 760, Title VII, Part D of the Public Health Service Act. At this meeting, ACICBL members will discuss issues related to the pending Committee reports.
• October 16-17, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. Matters proposed for discussion during the upcoming meeting include: Cancer Prevention and Control; Obesity Prevention and Control; Pregnancy Health; and Tobacco Cessation.
• November 6-7, 2019: CDC announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. Presentations and discussions will focus on a follow up on CLIAC recommendations; an update on the clinical laboratory workforce; improving integration of laboratory information systems with electronic health records; and future CLIAC topics. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
• November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
• November 13-14, 2019: HHS announced a public meeting entitled, Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of the meeting is to discuss issues related to the President’s initiative on “Ending the HIV Epidemic: A Plan for America,” building community capacity, strategies for engaging people with HIV who are out of care, models of clinical care, workforce issues, pre-exposure prophylaxis services in community health centers, and pending committee reports.

II. Congressional Hearings

House of Representatives

• On September 18, 2019, the House Committee on Appropriations Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Oversight Hearing: Mental Health Needs of Children in HHS Custody. Witnesses present included: Jonathan Hayes, Director, Office of Refugee Resettlement, Department of Health and Human Services; Ann Maxwell, Assistant Inspector General, Office of Inspector General, Department of Health and Human Services; and Jonathan White, Commander, Public Health Service Commissioned Corps, Department of Health and Human Services.
• On September 19, 2019, the House Committee on Energy and Commerce Subcommittee on Consumer Protection & Commerce held a hearing entitled, Profits Over Consumers: Exposing How Pharmaceutical Companies Game the System. Witnesses present included: Michael A. Carrier, Distinguished Professor, Rutgers Law School, Co-Director, Rutgers Institute for Information Policy and Law; David Mitchell, Founder, Patients for Affordable Drugs, Patients for Affordable Drugs NOW (P4ADNOW); Joanna M. Shepherd, Professor of Law, Emory University School of Law; and Jeff Francer, Senior Vice President and General Counsel, Association for Accessible Medicines (AAM).

III. Reports, Studies, & Analyses

• On September 16, 2019, the Government Accountability Office (GAO) released a report entitled, Medicaid: Additional CMS Data and Oversight Needed to Help Ensure Children Receive Recommended Screenings. GAO was asked to examine the extent to which Medicaid beneficiaries aged 20 and under receive health care services under the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit. Among other things, GAO examined what is known about the provision of EPSDT services based on CMS required annual state reporting and CMS oversight of the EPSDT benefit. To do this, GAO analyzed annual state reporting data from fiscal years 2010 through 2017, the most current year data were available; CMS documentation; and federal internal control standards. GAO also interviewed CMS officials and Medicaid officials from 16 states selected, in part, on the variation in number of beneficiaries and geographic diversity.
• On September 18, 2019, the Kaiser Family Foundation released a report entitled, Estimated Impacts of Final Public Charge Inadmissibility Rule on Immigrants and Medicaid Coverage. This analysis evaluates the potential impacts of the August 2019 Department of Homeland Security (DHS) final rule to change “public charge” inadmissibility policies. In particular, it examines impacts on the share of noncitizens who originally entered the United States without lawful permanent resident status who have characteristics that DHS could potentially weigh negatively in a public charge determination; and the number of individuals who might disenroll from Medicaid under different scenarios in response to the rule.
• On September 19, 2019, GAO released a report entitled, CMS Could More Effectively Ensure Its Quality Measurement Activities Promote Its Objectives. The Bipartisan Budget Act of 2018 contains a provision for GAO to review CMS’s quality measurement activities. For this report, GAO assessed the information CMS maintains on funding of health care quality measurement activities and described and assessed how CMS makes decisions to develop and to use quality measures. GAO analyzed CMS funding data for 2009 through 2018 and data on CMS quality measurement selections for 2014 through 2018. GAO reviewed CMS documentation related to its decisions on quality measurement and interviewed program and contractor officials.

IV. Other Health Policy News

• On September 17, 2019, a federal judge overturned the CMS rule that cut Medicare payments for some hospital clinic visits, siding with hospitals who sued to prevent the changes. U.S. District Judge Rosemary Collyer ruled that the Trump Administration had exceeded its authority when it expanded the so-called site-neutral pay policy to evaluation and management services at off-campus hospital clinics. The goal was for Medicare to pay the same rate to hospitals as to independent physicians. More information about this decision can be found here.
• On September 19, 2019, House Speaker Nancy Pelosi (D-CA) released the text of her drug-pricing bill. The bill is similar to the draft that was leaked last week; however, the updated bill directs the HHS Secretary to negotiate prices on drugs without generic or biosimilar competition while the earlier draft called for third-party price negotiation on drugs with less than two competing generics or biosimilars. More information about the bill can be found here.
• On September 19, 2019, President Trump signed an executive order entitled, Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health. The order is intended to encourage the development of better vaccines to protect against seasonal influenza as well as a potential pandemic flu outbreak. The order does not allocate additional funding for now, but it calls for an evaluation of current flu vaccine manufacturing abilities and a task force report including cost estimates. More information about the order can be found here.