Medicines licensing

More drugs qualifying for FDA accelerated review, driven by non-innovative medicines

Over the past 30 years, more drugs qualified for accelerated approval programmes with the FDA despite not being first-in-class medicines.

The US Food and Drug Administration (FDA), (Building 51 pictured) has four programmes to accelerate the development or approval of drugs addressing unmet medical needs or treating serious conditions

Source: Wikimedia Commons

The FDA (pictured) has accepted an increasing proportion of drugs into accelerated approval programmes 

The US Food and Drug Administration (FDA) has four programmes to accelerate the development or approval of drugs addressing unmet medical needs or treating serious conditions. However, their reliance on potentially less robust data makes them controversial.

Researchers at Brigham and Women’s Hospital and Harvard Medical School, Boston, evaluated the use of the FDA’s expedited drug development and review programmes between 1987 and 2014. During the course of the study period, 774 drugs were approved. There was a significant increase in the number of drugs qualifying for one of these programmes, with a 2.4% increase each year in the proportion of qualifying drugs (P=0.009).

The analysis shows that this trend was linked to approval of non first-in-class drugs, “which are less likely to be innovative or clinically transformative therapeutics”, say the authors in the BMJ (2015;351:h4633)[1].

Citation: Clinical Pharmacist DOI: 10.1211/PJ.2015.20069471

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  • The US Food and Drug Administration (FDA), (Building 51 pictured) has four programmes to accelerate the development or approval of drugs addressing unmet medical needs or treating serious conditions

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