Supreme Court Redefined Pharma Marketing Rules

Send us Fan Mail The Supreme Court's ruling in Loper Bright Enterprises v. Raimondo significantly impacts off-label marketing for pharmaceutical and medical device companies by challenging the FDA's authority to restrict off-label speech. This decision is poised to reshape the regulatory landscape that has traditionally limited such communications. Key Legal Context: - Historically, the FDA has prohibited off-label promotion based on misbranding statutes, which require drug and device labelin...