Real-world data or not-so-precise data: OPDP sends letter to the company for misplaced trust in real-world data | Arnall Golden Gregory LLP


On July 7, 2021, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter regarding a professional animated banner.1 According to the OPDP, the banner ad contained false or misleading claims and representations regarding the benefits of the prescription drug product. The main concern of the OPDP was the company’s use of a real-world study, which it said had many limitations. This did not raise any concerns about the safety of the product. As a result, the banner ad mislabelled the product. This Bulletin will review the Untitled Letter, focusing primarily on the study and offering our observations.

Highlights of the Untitled Letter

The OPDP found that the claims and presentations included in the banner ad created a misleading impression regarding the statistical significance of the risk of febrile neutropenia (FN) depending on the method of drug administration. The real-world study cited in making the claims included “multiple limitations” that would preclude such a conclusion, including the following:

  • The study was not designed to ensure that patients with FN were correctly identified for inclusion in the analysis, as the study used “an unvalidated algorithm” to identify study participants. The algorithm identified patients by selecting inpatient or outpatient consultations with diagnostic codes for neutropenia and fever or infection. The dossier data provided to the OPDP (the agency commissioned the study) did not include information regarding the performance characteristics (for example, sensitivity) of the algorithm or the diagnostic codes that were used.
    • According to the OPDP, the use of this unvalidated algorithm was a “significant limitation” due to the unknown performance characteristics of the algorithm and the potential for patient classification error at the start of the study.
    • In addition, the recorded data does not describe “any measures taken to ensure the quality and accuracy of the results generated by the algorithm”. Therefore, the extent to which the patients in the study actually had FN might be overestimated or underestimated.
  • The OPDP found that the study was not designed to ensure that patients using the different delivery methods “were adequately balanced or controlled for potential biases” because the study failed to control for factors other than the delivery device that could influence the incidence of FN in the comparison groups.
    • The agency noted that the patients in the study had a wide variety of clinical features, but the study report did not include important information, such as risk factors for FN from both groups or a conception or pregnancy. analytical strategy to minimize the risk of selection bias. However, even slight differences in populations could dramatically affect the incidence of NF and the study findings.
    • The OPDP concluded that “it cannot be excluded that selection bias is entirely responsible for the observed risk difference”.
  • The agency also objected to the use of the drug’s proper name in one case, compared to using the brand name of another product with a different method of administration, which could prevent providers health care provider to understand that the company’s drug has been used. in both arms of the study. Health care providers might conclude that a biosimilar is not as effective due to the confusion associated with using the proprietary name only.
    • The misleading claims were also of particular concern from a public health perspective, as they could undermine public confidence in the FDA-approved biosimilars provided by the allegedly inferior method, even though the cited study was “insufficiently conceived and excluded the draw conclusions.

According to the agency, a banner frame, which included some qualifying words “less prominently and in a smaller font” than the claims and presentations made in the previous frames, was not enough to tone down the presentation any more. important from other executives. The OPDP also noted that two study limitations were presented in certain banner ad frames under the heading “Real-World Study Limitations”. However, the agency found that including the two main flaws in the study’s design did not alleviate the misleading claims and presentations in the banner. The OPDP added that the misleading claims could undermine confidence in FDA-approved biosimilars, which are only delivered by a certain method of delivery.

Observations of the AGG

  • We receive several questions from customers regarding the use of real world data in promotional material. This untitled letter should serve as an example of the type of OPDP review and review exercises to ensure the appropriate use of this data.
  • When evaluating real-world data and its suitability for use in promotional material, companies should ensure that any limitations of the study are taken into account and ensure that the conclusions drawn from the study are scientifically and statistically sound. It might be appropriate to add disclaimers and qualifiers, although this may minimize, but not eliminate, the risk.
  • The company may have looked at the FDA’s 2018 guidance document, “Communications on Medical Products Complying with FDA Labeling”, when writing its claims. Some in the industry may have viewed the advice as a suggestion that the agency could take a flexible approach to certain promotional claims that are not on all corners of the product label, as long as the allegations do not present a safety problem. . The untitled letter reminds us that the FDA is still there and watching. The agency will take action if the promotion is linked to efficacy and is misleading or contrary, even if the claim does not pose an immediate safety risk.

[1] The untitled letter is available here.

[2] The guidance document is available here. We have also produced a Bulletin on the 2018 Guidance Document, which is available here.


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