Pharmaceutical Executive January 26, 2022
Delays in sponsors providing post-approval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways, along with high launch prices on many of these quasi-experimental medicines, is generating pressure for further review and reform of the agency’s accelerated approval (AA) process. FDA reports that only about half of AA products have completed research to confirm benefits, including many leading oncology treatments carrying “dangling” indications. The agency’s approval of Biogen’s Aduhelm Alzheimer’s treatment last year based on questionable surrogate endpoint data, moreover, has heightened calls among legislators and researchers for tightening study timeframes and clarifying program requirements.
Deliberations by FDA’s Oncologic Drugs Advisory Committee (ODAC) accelerated the debate with its April 2021 meeting to assess the lack of confirmatory evidence...
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