DTC For Accelerated Approval Drugs: US FDA Is Taking Another Look At Disclosure On Websites
Study will assess responses of cancer survivors and caregivers to disclosures that a drug received accelerated approval. FDA analysis found that 73% of 26 accelerated approval drugs cited approval pathway on product websites.
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Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.
Accelerated Approval: US FDA Labeling Guidance Calls Out Surrogate Endpoints Needing ‘Additional Context’
For Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state that accelerated approval was based on a specific surrogate; however, labeling for other types of drugs may need to reflect the clinical outcomes that are expected but not yet established, agency says.
Upcoming research projects will look at presentation of FDA approval status, timing of disease awareness ads, and healthcare professional views.