Companies Must Focus on Substantial Evidence in Ads, Former FDA Official Says

Substantial evidence should be the “watchword” for companies who do not want to be cited for violating regulations by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC), former agency Associate Chief Counsel Arnold Friede said.

Recent letters from DDMAC show the FDA is focusing on “substantial evidence” to support all advertising claims, especially comparative claims, according to Friede.

DDMAC’s warning letters, notices of violation and untitled letters are the best statement of the agency’s views on the law, Friede said in a piece for the Washington Legal Foundation.

To avoid problems with DDMAC, companies must ensure claims on their advertisements and promotional materials are supported by substantial evidence, even if experts could question the evidence’s reliability, Friede said.

Novartis recently received a warning letter for a promotional file card that suggested its drug, Exelon (rivastigmine tartrate) “is safer than has been demonstrated by substantial evidence,” among other violations.

Pfizer also received a warning letter for its print advertisement that claimed its drug Geodon (ziprasidone HCl) was more effective than haloperidol IM. “The FDA is not aware of any substantial evidence to support this claim,” the letter said.

The agency uses the definition of “substantial evidence” in the Federal Food, Drug and Cosmetic Act, he added. The act defines substantial evidence as “consisting of adequate and well-controlled investigations … by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved.” Evidence that satisfies this definition is more important to the FDA than lots of evidence or competent and reliable evidence, according to Friede.

Sometimes, claims in an advertisement are not taken from claims approved in labeling, such as when they come from a retrospective data analysis. “No matter how robust these analyses, DDMAC is likely to have a problem with them,” Friede said.

As long as the company has substantial evidence to support its advertising claims, it does not matter “how competent and reliable the supporting evidence might otherwise be to the company and to other experts in the field. To put it bluntly, DDMAC doesn’t really care,” Friede said. — Emily Ethridge