General Publications October 19, 2018

Alston & Bird Healthcare Week in Review, October 19, 2018

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 October 15, 2018, The Food and Drug Administration (FDA) issued guidance entitled, Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings. The purpose of this draft guidance is to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to advance and facilitate the development of drugs and biological products for the treatment of rare diseases.
  • On October 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs; Regulation to Require Drug Pricing. This proposed rule would revise the Federal Health Insurance Programs for the Aged and Disabled by amending the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC, or “list price”) of that drug or biological product. CMS is proposing this regulation to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize not only their out-of-pocket costs, but also expenditures borne by Medicare and Medicaid, both of which are significant problems.
  • On October 17, 2018, the FDA issued guidance entitled, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. There is a need to provide manufacturers with specific technical recommendations (e.g., appropriate threat modeling and other premarket testing) to help ensure device cybersecurity. This draft guidance updates the existing “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” guidance and is anticipated to better protect against risks, such as ransomware campaigns, that could disrupt clinical operations and delay patient care and risks. This draft guidance is not final nor is it in effect at this time.
  • On October 18, 2018, the FDA issued a rule entitled, Medical Devices: General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application. The FDA is classifying the light based energy source device for topical application into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the light based energy source device for topical application’s classification. The FDA is taking this action because the FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.

Event Notices   

  • 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 7, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The CLIAC will hear updates from other agencies on a range of laboratory-related issues, including laboratory interoperability.
  • November 8, 2018: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review.
  • 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

  • There were no health-related hearings this week.

House of Representatives

  • There were no health-related hearings this week.

III. Reports, Studies, & Analyses

  • On October 15, 2018, the Government Accountability Office (GAO) issued a report entitled, Medicaid: Access to Health Care for Low-Income Adults in States with and without Expanded Eligibility. The GAO analyzed a 2016 National Health Interview Survey (NHIS) and found that low-income adults in expansion states were less likely to report having any unmet medical needs compared with those in non-expansion states. The report further describes the number of demographic characteristics for low-income adults who were uninsured in expansion and non-expansion states.

IV. Other Health Policy News

  • On October 15, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced its members would take a new approach to direct-to-consumer (DTC) television advertising. PhRMA said its members’ DTC television advertisements will direct patients to information regarding their products, including list prices. For additional information is available here.
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