In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals.  These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict clinical benefit.  All products that are evaluated through the accelerated process are for serious or life-threatening conditions.

Because the surrogate endpoint and product subsequently approved through the accelerated process may not actually have a proven benefit demonstrated in full phase III clinical studies, post approval studies are required to confirm the benefit of the product.  If the post approval studies do not bear out the benefit, the product can be removed from the market.

Because of the nature of product approved under the accelerated process, FDA wants to determine whether the viewers of DTC ads understand that the product may not yet have a proven benefit or may not have all the risks of treatment identified at time of approval.  There are disclaimers required in the “prescribing information (PI) for a drug approved under accelerated approval [which] must include a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits, with reference to the clinical studies section for a discussion of the available evidence.”

For example, PIs for accelerated approval products include language such as:

  • This indication is approved under accelerated approval based on [surrogate endpoint]. An improvement in survival or disease-related symptoms has not been established.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial; or
  • Approval is based on a reduction in [surrogate endpoint]. There are no controlled trials demonstrating a direct treatment benefit such as improvement in disease-related symptoms, functioning, or increased survival.

FDA goes on to note that some sponsors may include this complex language (for most consumers and patients) in DTC ads but other DTC advertisements may not include such disclaimers.  Because the ability of consumers to understand these concepts may vary among the general population, the FDA will be conducting a study to determine how best to address the issue communicating the limitations of a product approved under the accelerated approval process when the product is subject to DTC advertising.

The FR notice referenced above provides an overview of comments received and the FDA response to those comments submitted in response to a “Federal Register of October 17, 2018 (83 FR 52478), [wherein] FDA published a 60-day notice requesting public comment on the proposed collection of information.”  The FR notice today goes on to further describe how the study will be conducted, how the Agency will select participants, and how the information might be used.

DTC advertising has always been somewhat controversial in terms of how much patients really understand or why patients decided to act on the viewed ad.  This study will be extremely useful in assuring that any DTC ad for a drug approved under the accelerated process will provide the viewer with helpful information that will establish a basis for providing a drug’s limitations at the time of approval for such products.