Hot on the heels of backlash of the accelerated approval of Biogen’s Alzheimer’s drug Aduhelm, the Department of Health and Human Services' (HHS') FDA is looking to rethink and redirect how these speedier approvals are marketed to consumers.
Most patients probably assume the drug they’ve been prescribed has gone through a long and arduous process before getting that all-important FDA green light. Of course, that’s not the case with an accelerated approval.
Not surprisingly, most pharma companies don’t call attention to the fact that the drug has received this fast track when advertising to the consumer.
The HHS found while some DTC websites did include disclosures about accelerated approval—often using similar wording as the indications and uses section from approved labeling—others, of course, did not.
According to the submission from the HHS about the new study:
“A content analysis of DTC websites for accelerated approval products found that 21 percent of the disclosures used language directly from the approved physician labeling, 79 percent of the disclosures used at least some medical language, but 27 percent of the websites did not include any disclosure that the products attained approval through this pathway (Ref. 2). The same analysis found that 84 percent of accelerated approval disclosures on DTC websites mentioned the approval basis, 68 percent mentioned unknown outcomes, and 47 percent mentioned confirmatory trials.”
Despite pushback from the pharma lobby, this has led to the request from the HHS for further research into the way the average consumer understands what this could potentially mean to them.
Specifically, the HHS plans to focus on oncology patients and their carers, “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.”
One study will test the two groups' comprehension of the different styles of wording.
Another study, not using the oncology groups, will test four versions of “consumer-friendly disclosure.”
The HHS hopes to get a clear view of just how consumers understand the role of accelerated approval and what that means for their health.