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 20, 2018, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Short-Term, Limited-Duration Insurance. The rule contains proposals amending the definition of short-term, limited-duration insurance plans, which according to HHS, will provide more affordable consumer choice for health coverage. Comments on the proposed rule must be received by April 23, 2018.
- On February 20, 2018, the Food and Drug Administration (FDA) issued a final rule entitled, Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. The FDA is amending its regulations on acceptance of data from clinical investigations for medical devices. The FDA is requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP). GCP includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, the FDA is also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.
- On February 22, 2018, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Patient Safety Organizations: Expired Listing for Quality Solutions. The AHRQ is authorized to list Patient Safety Organizations (PSOs), which are entities or organizations whose mission and primary activity are to improve patient safety and quality of care. A PSO can be delisted if it is found to no longer meet statutory and regulatory requirements. This notice includes those entities that are now delisted.
- On February 23, 2018, the FDA issued a notice entitled, Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability. The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance “Q11 Development and Manufacture of Drug Substances,” published November 20, 2012. The guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The questions and answers focus on chemical entity drug substances, and provide recommendations on the information that should be provided in marketing authorization applications and/or master files to justify the starting materials.
- 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 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.
- No health care-related hearings this week.
House of Representatives
- No health care-related hearings this week.
III. Reports, Studies, & Analyses
- On February 22, 2018, the Congressional Budget Office released a report entitled, How CBO and JCT Analyze Major Proposals That Would Affect Health Insurance Coverage. The CBO and Joint Committee on Taxation (JCT) estimate the budgetary effects of most types of major legislative proposals that would affect spending and revenues using a process that involves many steps. This report focuses on the process that the agencies use to analyze proposals affecting health insurance coverage for people under age 65, such as legislation that would make major changes to the Affordable Care Act.
IV. Other Health Policy News
- On February 23, 2018, a bi-partisan group of governors released a document entitled, A Bipartisan Blueprint for Improving Our Nation’s Health System Performance. The governors identified four principles: improving affordability; restoring stability to insurance markets; providing state flexibility and encouraging innovation; and improving the regulatory environment. The signing governors include: John Hickenlooper (D-CO); John Kasich (R-OH); Bill Walker (I-AK); Tom Wolf (D-PA); and Brian Sandoval (R-NV).