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FDA invites comments on research into disclosure statements in prescription drug promotional materials Posted 25/09/2020

The US Food and Drug Administration (FDA) has published a notice soliciting comments on its research entitled ‘Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials’. The purpose of the research is to build on prior investigation into the role of disclosures in educating or correcting misunderstanding in the context of prescription drug promotion.

Promotional claims about biosimilars have been a focus for FDA and the Federal Trade Commission in 2020, as they have been faced with industry concerns that public perception of biosimilars has been distorted by unintentional and deliberate misinformation, from regulatory language to competitor claims [1, 2].

The first phase of FDA’s proposed research will examine the impact of adding a disclosure about a secondary claim in direct-to-consumer and healthcare professional (HCP)-directed promotion in the context of a prescription drug website. The impact of the presence of a comparative claim about the secondary claim will also be examined. Participants will be randomly assigned to view one of four levels of secondary claim disclosure, and their perceptions of the product, the secondary claim and the disclosure, will be assessed.

The second, independent phase of the proposed research will examine disclosures about a biosimilar product. In both consumer and HCP audiences, the impact of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars will be assessed. The impact of the following will be examined: (1) adding a disclosure designating the product as a biosimilar; (2) adding general informational statements about biosimilars; and (3) naming a reference product. This approach will allow examination of the effect of disclosing biosimilar status, the additive effect of including one, two, or three additional basic statements of information about biosimilars, and it will allow the effect of naming the reference product to be measured. Perceptions of the biosimilar product and the disclosure will be assessed.

In public comments submitted on the draft outline for the study, several pharmaceutical companies and groups have proposed suggestions for improving the value of the study.

The Biosimilars Forum, representing biosimilar developers, requested a stronger emphasis in the study on garnering patient perceptions of biosimilar disclosures. ‘In the 6 years since the Forum was founded, we have found that while knowledge and perceptions of HCPs have increased … knowledge levels of patients are still low’, the group wrote.

Pharmaceutical company Bayer commented that the language used in the study sounded clinical and should be revised for consumer participants to be more ‘patient friendly’.

The Pharmaceutical Research and Manufacturers of America (PhRMA) group claim that the proposed study is ‘flawed’ for two reasons; that secondary endpoints are more important to a product’s indicated uses than the study design suggests, and that the study unfairly uses a genuine product, Humira (adalimumab) as a case example while using a fictitious biosimilar. AbbVie, which owns the Humira brand, also objected to this, stating the ‘FDA should refrain from using the name of a reference product currently on the market in the questionnaire and instead use a fictitious name for a reference product, as it does for the biosimilar’.

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FDA guidance sought on false and misleading information on biosimilars

1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on labelling and advertising of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-labelling-and-advertising-of-biologicals  
2. GaBI Online - Generics and Biosimilars Initiative. FDA and FTC collaborate to deter anti-competitive behaviour for biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/General/FDA-and-FTC-collaborate-to-deter-anti-competitive-behaviour-for-biologicals 

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Source: US FDA

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