On January 30, 2008, WLF issued a comprehensive report that concludes that FDA regulation of prescription drug promotion is being conducted in a manner that routinely violates both the First Amendment and FDA’s statutory mandate. The report, part of WLF’s “DDMAC Watch” program, is based on WLF’s study of all regulatory compliance letters sent by FDA within the past year to pharmaceutical manufacturers. The report concludes that FDA routinely orders suppression of truthful speech, demands that manufacturers engage in “corrective advertising” in the absence of any evidence that consumers have been misled by supposedly misleading advertising, and violates federal administrative law by using compliance letters (rather than established notice-and-comment procedures) to adopt new agency policies regarding product promotion. WLF issued a similar report last year, covering the previous year’s FDA compliance letters.
