Attorneys at the Washington law firm of McDermott Will & Emery advised in October that companies wishing to avoid FDA challenges to drug ads and promotional pieces should review their materials in all therapeutic categories to determine whether they make implied outcomes claims.
In an online analysis, the lawyers cautioned that if such claims are made, companies should be sure they are supported by “substantial evidence.” They said their advice was prompted by warning letters and notices of violation issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to five manufacturers of ADHD drugs.
The Warning Letters went out for a professional sales aid for Lilly's Strattera and a web page and Ty Pennington YouTube video for Shire's Adderall XR capsules. Notices of violation cited professional convention panels and a consumer web page for Johnson & Johnson's Concerta extended release tablets, a professional slide deck and web page for Novartis' Focalin XR, and a brochure for Mallinckrodt's Methylin chewable tablets and oral solution.
“The message that emerges from these letters taken as a whole is the agency's consistent legal position that what it views as representations about specific outcomes in a particular disease state must be supported by substantial evidence,” the attorneys wrote. They said that it appears that the FDA is broadening the nexus between disease information and product statements that it will consider to establish an implied outcomes claim.
“The agency may well construe any promotional piece that mentions both the consequences of a disease or condition and use of a particular product in the same piece as making implied outcomes claims that require substantial evidence to support them,” they continued. “Accordingly, a careful review of a company's advertising and promotional pieces appears to be in order. Likewise, companies may wish to consider an appropriate factual situation that might be used to challenge a DDMAC policy that always requires substantial evidence to support allegedly implied outcomes claims whenever an advertising or promotional piece mentions the consequences of a disease or condition and use of a particular product.”