|Footnotes for this article are available at the end of this page.
New Year. Same types of issues. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its first Warning Letter of 2021, and it identified many of the same types of unlawful promotional deficiencies that OPDP cited other companies for in the past (and which we have noted in previous Bulletins).1 In the recently-issued Warning Letter, OPDP objected to a banner ad and tabletop display for a Schedule II controlled substance, a prescription opioid drug that was submitted to FDA under cover of Form FDA 2253. The agency said that promotional materials made false and misleading representations about the risk and efficacy of the drug.
Here are some of the highlights of the Warning Letter.
- The Boxed Warning product, with a Risk Evaluation and Mitigation Strategy Program, claimed “TONGUE AND DONE” in connection with an image of the single-dose applicator, suggesting that the product, might be, according to OPDP, “a simple, one-step process when this is not the case.” OPDP noted that the Prescribing Information (PI) described multiple administration steps.
- The banner omitted information from the PI’s Dosing and Administration section about the maximum daily dosage; the banner created a “misleading impression about the safe use of [the product].”
- The banner provided a claim that failed to include the product’s limitations of use which, therefore, was misleading, according to OPDP. While the limitations of use were included with the full indication further below, as part of the full Important Safety Information (ISI), OPDP said that this was “intermingled with risk information in a paragraph format in a much smaller font size and a plain white background, and are accessible only if viewers ‘scroll’ down the banner.” OPDP concluded that “this does not mitigate the misleading impression.”
- The banner and display did not include the risk information, such as the Boxed Warning, Contraindications and Warnings, and Precautions, with a prominence and readability that was comparable as the presentation of the benefit information. OPDP said, “the risk information is relegated farther down in paragraph format with less prominence.”
Pete Townsend wrote (and Roger Daltrey sang), “Meet the Old Boss, Same as the New Boss.” New Year. Same types of OPDP violations.2 Many of the observations described in the Warning Letter are similar to what we have seen in prior years.
- OPDP continues to focus on high-risk drugs, such as those with Boxed Warnings.
- Companies should be careful about ease-of-use claims, particularly if the PI mentions multiple steps of administration.
- Firms should make sure the PI information and the claims are consistent; OPDP reads the PI.
- Do not forget to include the limitations of use in the text; omission or truncation can make the promotion misleading. We have noted this previously in Bulletins. The limitations of use are part of the indication. It is insufficient to merely place the limitations of use in the ISI at the bottom of the page.
- Fair balance includes the presentation of risk information in a comparable manner to the benefit information.
 The Warning Letter can be accessed at www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acelrx-pharmaceuticals-inc-613257-02112021.
 We note that OPDP has a new Acting Director but, as we have predicted, we do not expect a significant change in policy or enforcement.