Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, Congress and the Administration focused almost exclusively on addressing the coronavirus. Below provides an overview of the major published notices and announcements. We also include a list of resources related to the coronavirus outbreak at the bottom of the report.
I. Regulations, Notices, & Guidance
- On March 9, 2020, the Department of Health and Human Services (HHS) issued a notice entitled, Emergency Use Declaration. On February 4, 2020, the Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, the Secretary declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak.
- On March 13, 2020, HHS issued a notice entitled, Declaration under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. The Secretary is issuing this Declaration pursuant to section 319F-3 of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID-19.
- On March 13, 2020, the Food and Drug Administration (FDA) issued a guidance entitled, Competitive Generic Therapies. This guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT. In addition, this guidance includes information on the actions that FDA may take to expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. Further, this guidance provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for drugs designated as a CGT. This guidance finalizes the draft guidance of the same title dated February 19, 2019.
Event Notices
- March 10, 2020: FDA announced a public meeting entitled, Patient-Focused Drug Development for Stimulant Use Disorder. The purpose of the meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder.
- April 15, 2020: the National Institutes of Health (NIH) announced a Committee meeting of the National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Resource-Related Research Projects.
- April 16, 2020: the FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusions of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
II. Congressional Hearings
U.S. Senate
House of Representatives
- On March 10, 2020, the House Appropriation Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Centers for Disease Control and Prevention Budget Request for FY 2021.
- On March 11, 2020, the House Homeland Security Committee held a hearing entitled, Community Perspectives on Coronavirus Preparedness and Response.
- On March 11, 2020, the House Energy & Commerce Committee Subcommittee on Health marked up 13 health bills.
- On March 11, 2020, the House Committee on Oversight and Reform Committee held a hearing entitled, Coronavirus Preparedness and Response.
- On March 11, 2020, the House Appropriations Subcommittee on the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, Food and Drug Administration Budget Request for FY 2021.
III. Reports, Studies, & Analyses
- On March 13, 2020, the Congressional Budget Office (CBO) released a cost estimate of the Prescription Drug Pricing Reduction Act of 2019. The CBO estimated that the bill would save $94 billion over ten years.
IV. Other Health Policy News
- On March 13, 2020, President Trump announced a National Emergency Declaration for the coronavirus outbreak.
Informational Links on the Coronavirus:
Situation Updates:
Other Information:
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