Alston & Bird Healthcare Week in Review, December 22, 2017

• On December 18, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Ophthalmic Devices; Classification of the Tear Electrostimulation Device. The FDA is classifying tear electrostimulation device into class II (special controls). The FDA is taking the action because they have determined that classifying the device as special controls will provide a reasonable assurance of safety and effectiveness of the device. The FDA also believes the action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On December 18, 2017, the FDA issued a rule entitled, Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. The FDA is classifying the fetal head elevator device into class II (special controls). The FDA is taking the action because they have determined that classifying the device as special controls will provide a reasonable assurance of safety and effectiveness of the device. The FDA also believes the action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens
• On December 19, 2017, the FDA issued a guidance entitled, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability. The FDA intends to no longer grant orphan drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of over 200,000 people in the United States), unless the drug meets regulatory criteria for an orphan subset or the disease is considered a different disease from the disease in the adult population. According to the FDA, this clarification will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population and be exempt from studies typically required under PREA.
• On December 19, 2017, the FDA issued a rule entitled, Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. The FDA is classifying the image processing device for estimation of external blood loss into special controls. The FDA is taking the action because they have determined that classifying the device as special controls will provide a reasonable assurance of safety and effectiveness of the device. The FDA also believes the action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens
• On December 19, 2017, the FDA issued a rule entitled, Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. This rule establishes that certain active ingredients used in nonprescription (over-the-counter (OTC)) antiseptic products intended for use by health professionals in a hospital setting or other situations outside the hospital are not generally recognized as safe and effective. The FDA is issuing the rule after considering recommendations from the Nonprescription Drugs Advisory Committee (NDAC); public comments on the FDA’s notice of proposed rulemaking; and all data and information on OTC health care antiseptic products that have come to the FDA’s attention. The rule is effective December 20, 2018.
• On December 19, 2017, the FDA issued a guidance entitled, Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability. This draft guidance describes how the FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval.
• On December 22, 2017, the FDA issued a proposed rule entitled, Center for Devices and Radiological Health: Medical Devices and Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers. The FDA is announcing a proposed program for manufacturer reporting of certain device malfunction called the Voluntary Malfunction Summary Reporting Program. The program reflects goals for streamlining device malfunction reporting outlined in the commitment letter agreed to by the FDA and industry. The goals of the program include permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in summary format.
• On December 22, 2017, the FDA issued a rule entitled, Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid. The FDA is classifying the external negative pressure airway aid into special controls. The FDA is taking the action because they have determined that classifying the device as special controls will provide a reasonable assurance of safety and effectiveness of the device. The FDA also believes the action will enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On December 22, 2017, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period entitled, Medicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017. The interim final rule establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and uncontrollable circumstances during performance year 2017. Under the Shared Savings Program, providers and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs in performance-based risk agreements may also share in losses. The interim rule establishes extreme and uncontrollable circumstances policies for the Shared Savings Program that will apply to ACOs subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, effective for performance year 2017.
• On December 22, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule correction entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction. This corrects technical errors that appeared in the final rule with comment period published on December 14, 2017. Corrections were made to the Preamble and to the Addenda posted on the CMS website.

• January 9, 2018: The FDA announced a public workshop entitled, New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products. The purpose of the workshop is to present outcomes from FDA’s recent research activities and obtain input from the public on how analytical methods and procedures should be applied in the development and review of abbreviated new drug applications (ANDAs).
• 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 18, 2018: The HHS announced a public meeting of the Health Information Technology Advisory Committee (HITAC). The HTAC was established in accordance with the 21^st Century Cures Act and the Federal Advisory Committee Act. The HITAC will identify priorities and make recommendations to the National Coordinator of Health Information Technology on policy to advance an interoperable health information technology infrastructure.
• 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 to 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

U.S. Senate

•  There were no health care-related hearings.

House of Representatives

•  There were no health care-related hearings.

III. Reports, Studies, & Analyses

• On December 20, 2017, the Government Accountability Office (GAO) released a report entitled, Drug Industry: Profits, Research and Development Spending, and Merger and Acquisition Deals. The GAO analyzed revenues, profit margins, and merger and acquisition deals within the worldwide drug industry from 2006-2015. The GAO found that the estimated pharmaceutical and biotechnology sales revenue increased from $534 billion to $775 billion and about 67 percent of all drug companies saw an increase in their annual average profit margins. Among the largest 25 companies, annual average profit margin fluctuated between 15 and 20 percent. Non-drug company profits fluctuated between four and nine percent. Additionally, the number of reported mergers and acquisitions generally held steady, but the median disclosed value increased.

IV. Other Health Policy News

• On December 18-19, 2017, the Physician-Focused Payment Model technical Advisory Committee (PTAC) held their December meeting. The PTAC agenda can be found here. (Note: the deliberation of the Annual Wellness Visit at Rural Health Clinics model was held December 18, 2017, not December 20, 2017.)