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Neeraj G Patel and colleagues examine how drugs approved through the FDA breakthrough pathway are advertised to consumers and argue that the name contributes to overestimation of benefits In 2012, the US Congress gave the Food and Drug Administration authority to grant “breakthrough therapy” designation to expedite development and regulatory review of new drugs. The designation is used for potential treatments for serious conditions when preliminary evidence suggests they may perform substantially better than available alternatives on “clinically significant endpoints.” Preliminary evidence can include surrogate marker endpoints reasonably likely to predict clinical benefit, such as imaging changes and biomarkers. The programme has been successful in at least one way: an analysis of FDA approved drugs from 2015 to 2022 found that breakthrough designation was associated with a two year reduction in clinical development time.1 However, these therapies are approved on the basis o

United statesNew zealandJosephs rossNeerajg patelAyman mohammadReshma ramachandranDrug administrationUs congress