General Publications December 7, 2018

Alston & Bird Healthcare Week in Review, December 7, 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 December 3, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; Guidance for Industry; Availability. This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022.
  • On December 6, 2018, the FDA issued a notice entitled, Framework for a Real-World Evidence Program; Availability. The FDA is establishing a public docket to collect comments on a framework created by the Center for Drug Evaluation and Research and the Center for Biologic Evaluation and Research for implementing a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision making. This framework is entitled “Framework for the Real-World Evidence Program.” The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA establish a framework for implementing a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or satisfy post-approval study requirements. The FDA has created this framework to satisfy the Cures Act mandate and is establishing a docket to receive public comments.
  • On December 7, 2018, the Department of Health and Human Services (HHS) issued a final rule entitled, Patient Protection and Affordable Care Act; Adoption of the Methodology for the HHS operated Permanent Risk Adjustment Program for the 2018 Benefit Year Final Rule. This final rule adopts the HHS-operated risk adjustment methodology for the 2018 benefit year. In February 2018, a district court vacated the use of statewide average premium in the HHS-operated risk adjustment methodology for the 2014 through 2018 benefit years. Following review of all submitted comments to the proposed rule, HHS is adopting for the 2018 benefit year an HHS-operated risk adjustment methodology that utilizes the statewide average premium and is operated in a budget-neutral manner.

Event Notices   

  • December 11, 2018: The FDA announced a public meeting entitled, Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI. The meeting is intended to fulfill commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act (Cures Act) by soliciting comments on Drug Development Tool Qualification at FDA related to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); discussing taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.
  • April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging industry needs and technology initiatives.

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 December 7, 2018, The Commonwealth Fund issued a report entitled, The Cost of Employer Insurance is a Growing Burden for Middle-Income Families. The report found that between 2011 and 2016, average premiums for employer health plans climbed moderately but then spiked in 2017. The annual premium for a single person climbed above $7,000 in eight states and the average deductible for a single person policy rose to $1,808 in 2017.

IV. Other Health Policy News

  • On December 6-7, 2018, the Medicare Payment Advisory Commission (MedPAC) held their December meeting. The agenda is available here.
Media Contact
Nicholas Clarke
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Phone: 212.210.1222
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