The year 2012 was an active one for FDA enforcement in the drug product promotional arena. It started with the rollout of FDA’s guidance on responding to off-label requests for information (technically issued in December 2011) and ended with a “what now” scenario after the United States Court of Appeals for the Second Circuit found unconstitutional the criminal prosecution of a drug company’s sales representative for
off-label promotion. And, with 28 enforcement letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) for unlawful promotion, three of which were Warning Letters, the agency enters 2013 with momentum.
This Bulletin summarizes some of the enforcement themes in 2012 and areas of concern that drug companies should consider as they prepare promotional materials for this year. We will not review each enforcement letter or every type of violation in detail, nor will we identify any particular company. Rather, we intend to highlight the scope of enforcement to paraphrase the following saying — if we do not remember the past, we are doomed to repeat these mistakes in the future.
Overview of OPDP Enforcement
Spoiler Alert: as with previous years, the most common violations cited by OPDP include: omission and minimization of risk information, misleading efficacy claims, misleading superiority claims, and promotion of unapproved uses of a drug/broadening of indication (i.e., off-label promotion). OPDP continues to focus its enforcement resources on the following products: newly-approved, those with significant risks, those cited for violations or in complaints in the past, and those promoted with broad and widespread campaigns.
Poor Presentation of Risk Information
FDA continues to find problematic the presentation of risk information that is not comparable to benefit claims.
Some examples included:
• relegating risk information to “blurry and difficult to read” text in the final 7 seconds of a 3½ minute video, while using video and audio components for benefit
• a 3 minute and 55 second patient assessment video that did not discuss any risk information during its audio-visual presentation;
• a video that discussed drug benefits during its audiovisual presentation, while simultaneously presenting drug risks in rapidly scrolling small text at the bottom of the
• a pitch letter that omitted all product risks, despite an accompanying press release containing Important Safety Information;
• a 12 page patient brochure failing to discuss drug risks until page 8 under the heading “Side effects” (emphasis original);
• a brochure presenting efficacy claims in large bolded, colorful text surrounded by significant white space, but discussing risks in block paragraph format, in obscure
places, and without headers or other signals to alert readers; and
• a professional phone script that presented efficacy claims but no risks.
Please click the link below to download the full alert.