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- On November 13, 2018, the Food and Drug Administration (FDA) issued draft guidance entitled, Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Draft Guidance for Industry; Availability. This draft guidance provides recommendations to sponsors regarding the use of metastasis-free survival as an endpoint in clinical trials for nonmetastatic, castration-resistant prostate cancer development programs for drug or biological products regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
- On November 15, 2018, the Department of Health and Human Services (HHS) issued a notice entitled, Regulatory Agenda: Semiannual Regulatory Agenda. The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout HHS, offering for public review summarized information about forthcoming regulatory actions.
- On November 16, 2018, the FDA issued a notice entitled, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability. The FDA is announcing the availability of the Agency’s annual report entitled “Report on the Performance of Drug and Biologics Firms In Conducting Postmarketing Requirements and Commitments.” Under the Federal Food, Drug, and Cosmetic Act, FDA is required to report annually on the status of postmarketing requirements and postmarketing commitments required of, or agreed upon by, application holders of approved drug and biological products.
Event Notices
- 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.
- December 5, 2018: The FDA announced a public hearing to discuss its efforts to eliminate youth electronic cigarette use as well as other tobacco use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.
- December 5-6, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, Office of Infectious Diseases (BSC OID). The BSC OID will hear updates from the infectious disease national centers and discuss recent outbreaks and affected populations.
- 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.
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 November 16, 2018, the National Center for Health Statistics issued a report entitled, Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, January – June 2018. The report presented health insurance estimates from the first six months of the 2018 National Health Interview Survey. The report found, among other things, that 28.5 million people were uninsured at the time of the interview, which is not significantly different from 2017, but 20 million fewer people than in 2010.
IV. Other Health Policy News
- On November 13, 2018, the Centers for Medicare & Medicaid Services (CMS) sent a letter to State Medicaid Directors regarding opportunities to design service delivery systems for adults with a serious mental illness or children with a serious emotional disturbance. The letter outlines existing and new opportunities for states to utilize institutions for mental diseases (IMDs) for these patients using section 1115 waiver authority. The letter is available here.