Royce DuBiner on Department of Health and Human Services (HHS)

Drug Enforcement Administration Signals Intent to Reschedule Marijuana

On Dec. 19, 2023, Michael Miller, acting chief of the Drug Enforcement Administration (DEA) Office of Congressional Affairs, penned a letter to Congress advising that DEA is currently reviewing the Department of Health and...more

1/11/2024 / Controlled Substances , Controlled Substances Act , DEA , Department of Health and Human Services (HHS) , Marijuana , Popular , Schedule I Drugs

HHS Rescheduling, SAFER Banking Act May Change the Marijuana Landscape

In late August 2023, the Department of Health and Human Services (HHS) recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substances Act (CSA), signaling the...more

11/15/2023 / Banking Sector , Controlled Substances Act , DEA , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Marijuana , Marijuana Related Businesses , Popular

HHS Proposes Updates to 20-Year-Old Public Health Service Policies on Research Misconduct

The U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) released a notice of proposed rulemaking to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. HHS seeks...more

10/19/2023 / Department of Health and Human Services (HHS) , HHS Office of Research Integrity (ORI) , Medical Research , Proposed Rules , Public Comment , Public Health Service (PHS)

Contract Research Organization Acquisitions: Critical Due Diligence Pathways

Bidding for attractive businesses in the pharma services space continues to accelerate, with new interest emerging daily from investors who traditionally have not focused on the sector. With this influx comes an urgent need...more

8/8/2023 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Due Diligence , Food and Drug Administration (FDA)

Pharmacy Developments Related to COVID-19 Testing and Compounding of Critical Drugs

COVID-19 has forced the healthcare system to adapt to a unique set of circumstances. As reported in prior McGuireWoods updates, a number of state and federal developments have affected the practice of pharmacy during the...more

4/28/2020 / CGMP , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Pharmacies

FDA Changes Position on Clinical Trials and Respirators During COVID-19 Crisis

In light of the urgent need for medical intervention during the coronavirus pandemic, the Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control...more

3/23/2020 / Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Infectious Diseases

FDA’s Dual Approach to Enforcing Federal Food, Drug, and Cosmetics Act During COVID-19 Crisis

The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements...more

3/23/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , FDA Warning Letters , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Warning Letters

Countermeasures and Why They Matter for Liability During COVID-19

Under the Public Readiness and Emergency Preparedness Act, the secretary of the U.S. Department of Health and Human Services can issue a declaration to provide immunity for individuals and entities from any liability arising...more

3/23/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Immunity , Liability , Manufacturers , Pharmaceutical Industry , Public Readiness and Emergency Preparedness Act (PREP Act)

House Committees Bring Pelosi's Drug Bill to Floor; Action Expected by Late November

In keeping with U.S. House Speaker Nancy Pelosi’s schedule for pushing H.R. 3, the Lower Drug Costs Now Act, through the House of Representatives, the three committees of jurisdiction held mark-ups and passed the proposal, as...more

10/30/2019 / Department of Health and Human Services (HHS) , Drug Pricing , Employee Retirement Income Security Act (ERISA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , Section 340B

Royce DuBiner

McGuireWoods LLP

Popular Topics by This Author

Latest Posts › Department of Health and Human Services (HHS)