FDA to study disclosure information for accelerated approval products in oncology

Regulatory NewsRegulatory News | 11 June 2021 |  By 

The Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) wants to know how to better present disclosure information about products with accelerated approval to patients with cancer and their caregivers.
In two studies recently announced in the Federal Register, OPDP is seeking to confirm prior research on how patients interpret disclosure information for a product approved under FDA’s accelerated approval pathway on a direct-to-consumer drug website.
FDA’s accelerated approval pathway has been under increased scrutiny and interest lately in the wake of the agency’s high-profile approval of Biogen’s aducanumab. The approval was made over the recommendation of FDA’s adcomm advisors, and several panel members have resigned from their positions on the advisory committee over the decision. Although FDA is not obligated to follow the recommendations of its advisory committees, it usually does. (RELATED: FDA approves aducanumab for use in Alzheimer’s disease, Regulatory Focus 07 June 2021)
Preliminary research
OPDP wrote that FDA is required to note in the “Indications and Usage” section of prescribing information for products approved under the accelerated approval pathway that “continued approval for the drug or indication may be contingent on verification and description of clinical benefit in confirmatory trials,” and this information may also be on some direct-to-consumer websites.
According to an analysis performed FDA in 2018, 79% of websites had “some medical language,” 21% of direct-to-consumer websites had information “directly from the approved physician labeling,” and 27% did not contain any disclosure information about the accelerated approval pathway. For direct-to-consumer websites that mentioned the accelerated approval process, the approval basis was described in 84% of cases, unknown outcomes in 68% of cases, and confirmatory trials in 47% of cases.
When conducting a general-population study evaluating how participants reacted to FDA accelerated approval disclosure information on a fictitious drug, OPDP found participants preferred a consumer-friendly disclosure over one that used a physician-labeling disclosure or no disclosure, noting it “helped participants understand information related to the drug’s accelerated approval.” The disclosure contained information on the basis for the approval, unknown outcomes, and confirmatory trails. Overall, however, the office said the understanding of the disclosure itself was “low.”
OPDP plans to conduct two additional studies under the same circumstances, this time evaluating participants who are survivors of cancer or cancer caregivers. The office said public comments on the preliminary research suggested evaluating accelerated approval disclosure information for “people who have been diagnosed with the medical condition or who are caregivers,” specifically patients living with cancer and caregivers of these patients.
“Because a number of oncology products are granted accelerated approval, cancer survivors and cancer caregivers are more likely to seek out or be exposed to promotion for accelerated approval products than the general population. They may also be more familiar with cancer-related terms and concepts than the general population,” OPDP wrote in a notice outlining the two studies.
Study designs
In the first study, OPDP will ask cancer survivors and cancer caregivers to review consumer-friendly, physician-labeling, and no disclosure information for a fictitious drug approved under the accelerated approval pathway. They will also evaluate how the “prominence of the disclosure” impacts a participant’s interpretation.
The second study will address public comments expressed in the preliminary research study “that over-disclosure could dissuade consumers from considering accelerated approval products,” with one comment noting the “unknown outcomes” language in physician and consumer disclosures having the potential to discourage participants. OPDP’s second study will test consumer-friendly, physician-labeling, and no disclosure information in addition to three new, varying consumer-friendly disclosure messages.
“This will allow us to evaluate the impact on participants’ comprehension of the disclosure and perception of the fictitious drug when they view a disclosure with only the approval basis, the approval basis plus information about the unknown outcomes, the approval basis plus information about confirmatory trials, and finally the approval basis plus information about both the unknown outcomes and confirmatory trials,” OPDP wrote.
FDA is seeking comment on the studies; the deadline for public comment is 10 August.
Federal Register


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