Recent Warning Letters For Ads Reflect FDA’s Fixation On 'Substantial Evidence'

Many of us in the world of pharmaceuticals – and their promotion – are avid readers of the
compliance correspondence from FDA’s Division of Drug Marketing, Advertising, and
Communications (“DDMAC”) to pharmaceutical companies. We also avidly read the constitutional,
Administrative Procedures Act (“APA”), and other legal and policy criticisms leveled against much of
this correspondence by the Washington Legal Foundation (“WLF”). As a practical matter, it may not
matter all that much that FDA is in violation of the APA when it announces policy through compliance
correspondence instead of through notice-and-comment rulemaking. The fact remains that unless and
until a court holds that the agency has exceeded its statutory or constitutional authority, DDMAC
Warning Letters, Notices of Violation, and Untitled Letters represent the best and most authoritative
statement of FDA’s own views on the law. For this reason, and whether one agrees or disagrees with
the government’s assertions, they deserve careful study by anyone engaged in advertising and promoting
prescription drugs or counseling clients who do. Moreover, and while the letters do not say so
expressly, DDMAC compliance correspondence also reflects, and must be understood in the context of,
the broader drug safety debate that will soon culminate in new drug safety legislation from Congress,
including new provisions that directly implicate prescription drug advertising. Finally, they represent a
mirror for many of the criticisms of the industry that abound in the generally toxic external political and
public policy environments.