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.

Render illustration of computer keyboard; with the print OFF-LABEL on a red button; and a small bottle of pillls.

The US FDA is treading lightly in its enforcement of advertising regulations because of First Amendment concerns, one reason the number of letters issued has plummeted in recent years, Center of Drug Evaluation and Research Director Janet Woodcock said.

The comment confirms what stakeholders had long suspected in the wake of recent court rulings that seemed to place the...