|Footnotes for this article are available at the end of this page.
Instead of sending a turkey and cranberry sauce, in the spirit of 2020 where nothing is normal, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) made a different delivery this year for Thanksgiving. It sent an Untitled Letter to a pharmaceutical company for sending a misleading email to healthcare professionals about the prescription drug’s risks and efficacy.1 We will not go through each of the specific facts of the letter, but this Bulletin will highlight some of those issues that we think are more important. We will also note our observations and recommendations.
- The product is indicated for pediatric patients as part of a combination chemotherapy regimen.
- The product contains a Black Box Warning.
- OPDP had provided advisory comments to the predecessor company a few years earlier, but the company, which received the Untitled Letter, failed to provide the serious risks “in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”
- The email provided many claims of the product’s benefits but did not include a significant warning and precaution.
- OPDP objected to the presentation of the (limited) risk information compared to the benefit information. It said that “promotional materials are misleading if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.” As an example, the company provided the benefit claims in the email’s body in a bulleted list. However, the risk information, such as the Black Box Warning, was presented after the signature block, “which typically signals the close or end of a correspondence.”
- OPDP acknowledged that the email provided statements, such as “For Full Prescribing Information of [Product], please click here: [Full Prescribing Information]” and “For more information on [Product], please click here: [Product website].” However, OPDP also said that this was not sufficient to overcome the lack of prominence of the Black Box Warning and the omission of much of the risk information.
- The email stated that the drug was available to treat the indicated disease, but did not provide the complete indication. The email failed to specifically note that the indication was limited to pediatric patients, and was only approved as part of a combination therapy. Again, the full indication was noted at the bottom of the email, after the signature block, under the heading “Important Safety Information,” but this was not sufficient to “mitigate the misleading impression.”
AGG Observations and Recommendations
- Many of the types of concerns raised should not surprise the industry. Minimization of risk information (particularly for Black Box Warning products), failure to include a full indication, presentation of risk information and prominence, and failure to heed OPDP’s previously-stated concerns will likely raise regulatory scrutiny.
- One is not “required” to follow OPDP’s advisory comments, but a company that fails to follow the recommendations as much as possible does so as its risk – as this company found (even advisory comments provided to a predecessor company).
- OPDP is reminding the industry that it cannot put the “good” marketing messaging in larger, eye-catching text and then relegating the less positive (but required) risk information at the bottom of the page. Prominence and conspicuousness are key. It is also not an excuse to say that the medium, such as an email (or social media) may not allow for a “pretty presentation.” As we remind clients, if one chooses the medium for the benefits, one assumes the challenges and risks that go with that medium.
- We were struck by the specificity of OPDP’s comments about the presentation of risk information after the signature block. We know that many companies present the marketing message in the body of the text of the email or social media, with little risk information in the text, and then put the full “Important Safety Information” at the bottom, often with the rationale that the risk information is “there” and, therefore, compliant. Companies should carefully review the promotional material in context to ensure that the risk information is not misleading and the risk information is prominent and not buried, even if “there.”
 See: https://www.fda.gov/media/144115/download