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Prescription Drugs › Regulatory Requirements › Constitutional Challenges

Brownstein Hyatt Farber Schreck

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

Brownstein Hyatt Farber Schreck on

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

Morgan Lewis

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Morgan Lewis on

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

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