As Eli Lilly’s decision to pull a cancer treatment from the market two weeks ago shows, drugs approved under the US Food and Drug Administration’s (FDA) accelerated approval pathway may not always live up to early promising data.
And though failing to verify clinical benefit is rare
for an accelerated approval product, FDA explained Tuesday in the Federal Register
, the agency is interested in finding out more about how companies that win accelerated approvals advertise their products directly to consumers because such advertisements can be misleading.
Specifically, FDA is planning study the presence, wording and prominence of a disclosure communicating information related to the drug’s accelerated approval in direct-to-consumer (DTC) promotional materials.
“This information includes the use of surrogate or intermediate clinical endpoints to support approval, the uncertainty about the relationship of the surrogate or intermediate clinical endpoint to the predicted clinical benefit, and the need for confirmatory trials,” FDA said.
The agency said it hypothesizes that study participants will be more likely to notice disclosures when they are presented more prominently. And the study will also evaluate what happens when the disclosure is written in consumer-friendly language versus language that is the same or similar to language directed at health professionals in FDA-approved prescription drug labeling.
“Despite its complexity, sponsors often use this language from the PI [prescribing information] in direct-to-consumer (DTC) promotional materials for drugs approved under accelerated approval. In other cases, DTC promotion of accelerated approval products does not communicate the unique considerations and potential limitations inherent in the accelerated approval process,” FDA explained.
The decision to conduct the study follows a previous study
conducted by FDA officials and published last September that found DTC websites for accelerated approval drugs “do not consistently communicate the accelerated approval information” for consumers in a “prominent, comprehensive, or readable manner.”
“Most (73%) of the websites contained an accelerated approval disclosure. Most of the disclosures (84%) included the basis for accelerated approval, whereas 68% stated that the clinical benefit of the product was unknown and 47% conveyed the need for additional research to confirm study findings,” the study found.
In many cases, FDA added, the available data for accelerated approval products do provide information about disease progression, without providing information on overall survival.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of an Accelerated Approval Disclosure