NAD Refers Claims Made by Synergy to FTC After Pharma Company Declines to Participate; Claims Challenged by Allergan

New York, NY – Nov. 8, 2017  – The National Advertising Division has referred advertising claims made Synergy Pharmaceuticals, Inc.,  to the Federal Trade Commission after the advertiser declined to participate in a proceeding before NAD.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

Claims made by Synergy in online advertising, medical journals, and printed waiting room advertising, as well as through in-person detailing, for its Trulance Chronic Idiopathic Constipation prescription drug were challenged by Allergan, Inc., the maker of a competing drug, Linzess.

Allergan challenged express claims that included:

• “Diarrhea isn’t the goal of constipation relief. It’s a compromise.”
• “New once-daily Trulance may provide more regular, well-formed bowel movements for adults with Chronic Idiopathic Constipation (CIC).”
• “Going shouldn’t mean going to extremes.”
• “Diarrhea is not efficacy – it’s time to address the age-old tradeoff in CIC.”
• “Now there’s Trulance, the only treatment that is thought to replicate the pH-sensitivity of naturally occurring uroguanylin.”
• “Trulance provided more regular, well-formed bowel movements.”

Allergan also contended that the advertising implied that Trulance can be used without the risk of diarrhea and is superior to Linzess.

Synergy, which decided not to participate in NAD’s review, denied Allergan’s characterization of its claims, and contended that the FDA has primary jurisdiction for the advertising and promotion for prescription pharmaceutical products and is uniquely positioned to evaluate prescription pharmaceutical advertising.

NAD determined that the challenged claims are within its purview. As NAD noted in its decision, the FDA’s mandate differs from that of the NAD, which is charged with ensuring that advertising claims, in the context in which they appear, are truthful and accurate such that consumers can make informed purchasing decisions.

“While the FDA has jurisdiction over the advertising and promotion of prescription pharmaceutical products, FDA jurisdiction does not preclude NAD from providing self-regulatory guidance on the challenged advertising, particularly whether the challenged advertising for Trulance communicates a misleading message about competing products,” NAD said.

Given that the advertiser has elected not to participate in this NAD inquiry, NAD will refer this matter to the appropriate regulatory authorities pursuant to Section 2.10(B) of NAD/NARB Procedures.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.