Thomas Barker on Food and Drug Administration (FDA)

HHS Under the Second Trump Administration

On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of...more

4/2/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Healthcare , Healthcare Reform , Loper Bright Enterprises v Raimondo , Regulatory Reform , Rulemaking Process , Trump Administration

Chevron’s Demise—And What It Means for Healthcare and Life Sciences Companies

Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more

7/3/2024 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Chevron Deference , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Loper Bright Enterprises v Raimondo , SCOTUS , Statutory Interpretation

Enforcing Medicaid’s Guarantee of Access to Prescription Drugs

Over the years, we’ve written about the difficulties in challenging the entitlement to Medicaid in the federal courts. In light of a series of Supreme Court decisions dating back to 1990, the pathway for an aggrieved Medicaid...more

3/15/2022 / Affordable Care Act , Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Medicaid , Pharmaceutical Industry , Prescription Drugs

Paying for Value in Medicaid Prescription Drug Coverage

My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or...more

7/6/2020 / Best Buy , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , MDRP , Medicaid , Medicaid Drug Rebate Program , Prescription Drug Coverage , Value-Based Purchasing

Antitrust Implications of HHS Proposal to Limit Manufacturer Rebates

I. Introduction - In May 2018, the Department of Health and Human Services (HHS) introduced a “Blueprint” and Request for Information setting forth proposed actions and policies as a means to purportedly help lower...more

8/28/2018 / Antitrust Division , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Centers for Medicare & Medicaid Services Proposes Changes to Six Protected Class Rule under Medicare Part D

On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (the “MMA”) was signed into law by former President George W. Bush1. Prior to the enactment of the MMA, Medicare prescription drug...more

1/13/2014 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Healthcare , Medicaid , Medicare , Medicare Modernization Act , Medicare Part D , Prescription Drugs

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more

12/24/2012 / Excise Tax , Exemptions , Food and Drug Administration (FDA) , IRS , Manufacturers , Medical Devices

Thomas Barker

Foley Hoag LLP

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