Craig Bleifer at McGuireWoods LLP

As FDA Cracks Down on Direct-to-Consumer and Social Media Ads, Pharma Companies Should Prepare

On Sept. 9, 2025, the U.S. Department of Health and Human Services and the Food and Drug Administration jointly announced a crackdown on deceptive direct-to-consumer (DTC) pharmaceutical advertising, including promotion...more

9/17/2025 / Advertising , Department of Health and Human Services (HHS) , Enforcement Actions , Food and Drug Administration (FDA) , Influencers , Pharmaceutical Industry , Popular , Prescription Drugs , Regulatory Oversight , Rulemaking Process , Social Media

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

5/6/2025 / Appeals , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Regulatory Requirements

First Circuit Adopts “But For” AKS Standard, Leaving Third Circuit Alone in Causal-Link Standard

On Feb. 18, 2025, the U.S. Court of Appeals for the First Circuit adopted the “but for” causality standard for violations of the federal Anti-Kickback Statute (AKS) that give rise to violations of the federal False Claims Act...more

3/5/2025 / Anti-Kickback Statute , Appeals , Causation , Department of Justice (DOJ) , False Claims Act (FCA) , Healthcare Fraud , Medicare , Pharmaceutical Industry , Relators

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more

1/30/2025 / Centers for Medicare & Medicaid Services (CMS) , CMMI , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , MedPAC , New Guidance , Pharmaceutical Industry

Dairy Industry Alerted to New USDA Order Requiring National Raw Milk Testing

In response to an outbreak of the H5N1 strain of bird flu among dairy cows in at least 15 states, the U.S. Department of Agriculture (USDA) issued a new federal order (the Order) requiring dairy farms and other entities...more

12/11/2024 / Dairy Farmers , Department of Health and Human Services (HHS) , Food Manufacturers , Food Safety , Food Supply , USDA

Craig Bleifer

McGuireWoods LLP

Popular Topics by This Author

Latest Publications

As FDA Cracks Down on Direct-to-Consumer and Social Media Ads, Pharma Companies Should Prepare

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

First Circuit Adopts “But For” AKS Standard, Leaving Third Circuit Alone in Causal-Link Standard

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

Dairy Industry Alerted to New USDA Order Requiring National Raw Milk Testing

Craig Bleifer

McGuireWoods LLP

Popular Topics by This Author

Latest Publications

As FDA Cracks Down on Direct-to-Consumer and Social Media Ads, Pharma Companies Should Prepare

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

First Circuit Adopts “But For” AKS Standard, Leaving Third Circuit Alone in Causal-Link Standard

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

Dairy Industry Alerted to New USDA Order Requiring National Raw Milk Testing

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