February 18, 2015

Five Lessons From OPDP's First Enforcement of 2015: (Lack of) Precision Carries the Day

The first Untitled Letter of 2015 from the Office of Prescription Drug Promotion (OPDP) provides valuable lessons on drug promotion. 

OPDP issued its first Untitled Letter of 2015, after a 2014 relatively light on enforcement. Could this signal more enforcement to come in 2015? In this letter, OPDP continues its enforcement focus on promotion that it believes presents potential safety risks, such as suggesting a drug is approved for a broader group of patients than indicated and minimizing risks associated with a drug. 

This Untitled Letter was sent to Luitpold Pharmaceuticals for a video segment about Injectafer, its new intravenous treatment for iron deficiency anemia. The video is presented in the form of an interview with a physician blood specialist and a marketing manager at a division of Luitpold. With this enforcement, OPDP makes it clear once again that drug promotion must be precise regardless of the format used.

Here are five important things to consider about this development: 

  1. Be precise. In an example of the importance of precision in drug communications, OPDP objected to a statement in the video noting that the drug is “the first IV iron approved in the U.S. for patients with iron deficiency anemia caused by any disease. In fact, it’s also for patients who are intolerant to oral iron or where oral iron is unsatisfactory, and it’s also approved in adult patients in non-dialysis chronic kidney disease.” OPDP interpreted these statements as suggesting that Injectafer is approved to treat all patients with iron deficiency anemia. Injectafer is only approved to treat patients who cannot tolerate or have had unsatisfactory response to oral iron supplementation, or patients who have non-dialysis dependent kidney disease. In recording video segments, speakers may stray from the approved indication. This letter illustrates that it is essential to communicate the exact indication for your product regardless of the method of promotion.

  1. Provide appropriate risk information. The video does not present risk information for Injectafer as part of the interview. Rather, risk information is presented only briefly, in small text at the bottom of the screen. OPDP notes that the risk information is not presented with sufficient emphasis. This is of particular significance to OPDP because the video discusses the significant risks associated with other treatments for iron deficiency anemia. OPDP noted that Injectafer is also associated with many of the risks discussed for the other treatments (and that some of them occur at higher rates with Injectafer). OPDP found the lack of sufficient emphasis and minimization of risk information misleading.

  1. Don’t omit material facts — precision is important in discussions of dosing, too. The video states that Injectafer is the first iron approved by the FDA “as a high single dose IV iron and a total dose of IV iron.” The PI, however, states that Injectafer is to be administered in two doses separated by at least seven days. Although the video discusses the dosing regimen elsewhere, OPDP finds that it does not correct the misleading impression of the “single dose” statement.

  1. Be aware that patient success stories can constitute claims. In the video, the blood specialist is asked about patient success stories. He discusses a “tea and toast lady living alone” who wasn’t able to take oral iron who “blossomed like a rose” with Injectafer. In a common objection, OPDP notes that there is no evidence to support a claim that Injectafer can have a positive impact on a patient’s well-being.

  1. Note OPDP’s broad interpretation of comparative claims. The video states that Injectafer can offer a “huge benefit” to patients living with iron deficiency anemia and that having this new option is “transforming the way anemia is treated.” OPDP refers to these statements as misleading and points out that it is not aware of any evidence to support the implication that Injectafer offers significant advantages over existing treatments.
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