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Process plagued by missing efficacy data and questionable evidence Some experts argue that FDA’s standards for evidence are too low Since the US Food and Drug Administration (FDA) established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorised have not been confirmed as clinically effective, an investigation by The BMJ has found. Elisabeth Mahase, clinical reporter at The BMJ, carried out an in depth analysis of FDA data up to 31 December 2020 and found that of these 112 drugs approved in the last 28 years a fifth (24) have been on the market for more than five years and some have been on the market for more than two decades – often with a hefty price tag.

Elisabeth mahaseCelecoxib celebrexRachel sachsHuseyin naciUs government accountability officeWashington universityInstitute for clinicalLondon school of economicsDrug administrationLondon schoolAccountability officeEconomic reviewரேச்சல் சாக்ஸ்எங்களுக்கு அரசு பொறுப்பு அலுவலகம்வாஷிங்டன் பல்கலைக்கழகம்நிறுவனம் க்கு மருத்துவ