The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) recently criticized the makers of Aranesp for a direct mailer that was allegedly in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the mailer was found to be false or misleading because it omitted important risk information, suggested use beyond that which was substantiated, made unsubstantiated efficacy claims, and omitted material facts. OPDP also found that the mailer evidenced that Aranesp was intended for a new use not previously approved by the FDA.
Promotional materials are misleading where they neglect to reveal material facts in light of representations made or with respect to consequences that may result from the drug’s use as recommended or suggested by the materials. OPDP found that important risk information was omitted from the Aranesp direct mailer which misleadingly suggested the drug was safer than has been demonstrated. The mailer did refer to full prescribing information and the website for more information but those references were not sufficient to mitigate the misleading omission of the risk information according to OPDP.
OPDP also found that the promotional materials suggested use in a broader range of conditions or patients than has been demonstrated to be useful by substantial evidence or substantial clinical experience and that the mailer contained misleading statements regarding efficacy, and finally omitted material fact. Due to the above the FDA found the mailers distribution violative of the FD&C Act. Companies involved in the manufacturing, marketing and distribution of products subject to FDA oversight must not only ensure that promotional materials comply with all laws and regulations but routinely monitor statements within those materials to ensure they remain in compliance with evolving science. While the Aranesp direct mailer letter was not a specific Warning Letter from the FDA, it is a reminder to review and amend promotional materials to reflect current developments with science and the law.