The increasingly conservative stance of the Food and Drug Administration (FDA) against pharmaceutical companies continues to impact public relations and advertising agencies servicing this sector. Actions over the past year relating to adverse event reporting, social media and media statements highlight this changing approach.
Janssen Pharmaceuticals and Johnson & Johnson were hit with multimillion and billion dollar fines, respectively, in connection with the promotion of Risperdal, an anti-psychotic drug, for off-label uses. Janssen had received repeated warnings over what the FDA contended were misleading marketing messages targeting physicians. These actions recall the DOJ’s settlement on behalf of the FDA with GlaxoSmithKline for $3 billion for violations that, the government alleged, included unlawfully promoting certain drugs and failing to report adverse event data.
The FDA also cracked down on the distribution of pharmaceuticals marketed for off-label uses. Late last year, the CEO of Aegerion Pharmaceuticals appeared on “Fast Money” and promoted Juxtapid for unapproved off-label uses. In a warning letter, the FDA determined that the statements caused the drug to be misbranded and made the distribution of the drug a violation of the Food, Drug, and Cosmetic Act. This action echoes the FDA’s enforcement action against Cornerstone Therapeutics for allegedly failing to include risk information in a pitch letter, even though the press release accompanying the pitch letter included the risk information.
Over the past year, the FDA even expanded its enforcement presence to social media sites and search engines. In a Warning Letter to AMARC Enterprises, the FDA determined that when a company “Likes” a consumer’s statement, it’s the same as adopting that statement. In AMARC’s case, the consumer said that AMARC’s dietary supplement “enabled me to keep cancer at bay without the use of chemo and radiation.” The FDA found that AMARC’s “Like” impermissibly promoted its dietary supplement for conditions that caused the product to be a drug.
Looking ahead to 2014
Adapting to the FDA’s increasingly conservative stance will require:
Working in conjunction with pharmaceutical companies to ensure all promotional materials, speeches and marketing materials promote drugs for approved uses and do not inadvertently promote drugs for off-label uses.
Managing pharmaceutical companies’ social media presence and drafting social media policies to ensure that they do not “like” posts that may invite FDA enforcement actions.
Carefully reviewing agreements with pharmaceutical companies. If an advertiser or agency is required to report adverse events under the agency-client agreement, then the agency should have policies and procedures in place to ensure that adverse events are reported appropriately.