Supreme Court Redefined Pharma Marketing Rules
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 labeling to specify only F...