As the FDA keeps up the pressure on marketers for making unsubstantiated claims in their professional promotions, a Pfizer legal expert says companies may be able to avoid such notices by supporting all advertising claims with “substantial evidence.”
In March the Division of Drug Marketing, Advertising and Communications chief Thomas Abrams said he was seeing too many ads that omit or downplay risk information and that his office was stepping up enforcement to put pharmaceutical marketers on notice that they are not beyond reproach for such missteps.
“There appears to be a lack of attention on risk information, as the focus is so much on benefit,” Abrams said at the time.
His ire has spread to unsubstantiated claims. According to the FDA Law Blog, two recent warning letters to Novartis and Pfizer reinforce a DDMAC focus on ensuring that promotional pieces contain substantial evidence to back up ad claims and proper presentations of safety data. “Certainly ‘substantial evidence' is the DDMAC watchword for now and for the foreseeable future,” read a recent post.
The bloggers at food and drug law firm Hyman, Phelps & McNamara, which produces the blog, drew their inspiration from an article by Arnold Friede, Pfizer senior corporate counsel. Even before its most recent missives, DDMAC correspondence over the last few months “clearly indicates that FDA insists on ‘substantial evidence' to support all advertising claims, including, notably, comparative claims (but not limited to comparisons),” wrote Friede in the article published by the Washington Legal Foundation last week.
The Food and Drug Act sets out the definition of “substantial evidence.” It consists of adequate and well-controlled investigations, including clinical investigations—the same standards FDA applies to substantiation for advertising claims on approved products, he wrote.
In a somewhat ironic punctuation to Friede's Aug. 10 article, DDMAC's July untitled letter to Pfizer called the firm on the carpet for making an unsubstantiated superiority claim in promotional materials for Geodon (ziprisadone), its injectable for treating acute agitation in schizophrenic patients, and for leaving out important risk information. Its warning letter this month to Novartis objected to unsubstantiated superiority claims for Alzheimer's treatment Exelon (rivastigmine) made in a promotional card.
Such correspondence must be studied, urged Friede, who had this “simple and relatively straightforward" advice: "If you want to avoid problems with DDMAC, ensure that claims in prescription drug advertising and promotion are supported by 'substantial evidence,' no matter how competent and reliable the supporting evidence might otherwise be to the company and to leading experts in the field. To put it bluntly, DDMAC doesn't really care. What DDMAC cares about is like 'location,' 'location,' 'location' in the real estate purchase context. It's about 'substantial evidence,' 'substantial evidence,' 'substantial evidence.'"