Drugmakers urged to update ATTR-CM claims as competition grows

Competition in ATTR-CM is putting new pressure on how drugmakers describe their products, critics say.

With three approved treatments now available, commentators argue that promotional language written for a one-drug market risks misleading patients. A recent piece on the credibility crisis in pharmaceutical marketing cited ATTR-CM as a test case. Patient advocates have questioned Pfizer's use of exclusivity wording for Vyndamax after rivals reached the market.

FDA rules on prescription drug advertising bar promotion that creates a misleading impression. The agency's enforcement letters this year have repeatedly found that footnotes and disclaimers do not cure a misleading headline claim.

None of the three manufacturers is alone in facing questions. Alnylam received an FDA untitled letter in April over mortality claims on the Amvuttra website, which the agency later said had been addressed.