David Dorsey at Brownstein Hyatt Farber Schreck

The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads

Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more

7/8/2025 / Advertising , Constitutional Challenges , Drug Pricing , First Amendment , Food and Drug Administration (FDA) , Marketing , Pharmaceutical Industry , Prescription Drugs , Proposed Legislation , Regulatory Requirements

Most-Favored-Nation Drug Pricing in the U.S.

On May 12, President Trump issued an Executive Order (EO) on drug pricing: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” The EO requires a 30-day government negotiation with drug companies...more

6/10/2025 / Drug Pricing , Executive Orders , Government Agencies , Medicaid , Medicare , Pharmaceutical Industry , Popular , Prescription Drugs , Rulemaking Process , Statutory Interpretation , Trump Administration

Reflections on the Inflation Reduction Act’s Pill Penalty

The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food...more

5/5/2025 / Biosimilars , Drug Pricing , Generic Drugs , Healthcare Reform , Inflation Reduction Act (IRA) , Medicare , New Legislation , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs

FDA Drug Review Threatened by a Government Shutdown

The Food and Drug Administration (FDA) is not likely to continue to review and approve human drugs or medical devices if the federal government shuts down in March....more

3/3/2025 / Federal Funding , Food and Drug Administration (FDA) , Government Shutdown , Medical Devices , Prescription Drugs , Regulatory Agenda

FDA Nominee Makary on the Orphan Drug Act

President-elect Trump’s nominee for commissioner of Food and Drugs, Martin A. Makary, MD, MPH, argued in 2016 that Congress should reform the Orphan Drug Act (ODA) because drug companies “are gaming the system to use the law...more

12/18/2024 / FDA Approval , Food and Drug Administration (FDA) , Generic Drugs , Life Sciences , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs

FDA’s Drug Review Gold Standard

Robert F. Kennedy Jr., President-elect Trump’s nominee for secretary of health and human services, has said one of his mandates from the president-elect is to return agencies to the gold standard of scientific review. This...more

11/25/2024 / Drug Approvals , Food and Drug Administration (FDA) , Health & Safety Standard , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Trump Administration