Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says
Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
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Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
GlaxoSmithKline win shows value of going to court as US FDA is less likely to take action against comparative promotions. Court was swayed by GSK survey showing likely harm caused by ‘false and misleading statements not supported by scientific studies.’