Clinical and Regulatory Features of Drugs Not Initially Approved by the FDA

• Published in: Clinical pharmacology and therapeutics Vol. 94; no. 6; pp. 670 - 677
• Main Authors: Wang, B, Avorn, J, Kesselheim, A S
• Format: Journal Article
• Language: English
• Published: Basingstoke Blackwell Publishing Ltd 01-12-2013; Nature Publishing Group
• Subjects: Advisory Committees; Biological and medical sciences; Biological Products; Databases, Pharmaceutical; Drug Approval - legislation & jurisprudence; Drug Approval - organization & administration; Drug-Related Side Effects and Adverse Reactions; General pharmacology; Medical sciences; Miscellaneous; Pharmaceutical Preparations; Pharmacology. Drug treatments; United States; United States Food and Drug Administration; United States; North America; America; Marketing authorization; Human; Drug; Regulation; Food and Drug Administration
• ISSN: 0009-9236; 1532-6535
• DOI: 10.1038/clpt.2013.165

US Food and Drug Administration (FDA) denials of New Drug Applications (NDAs) are often controversial, yet little is known about the basis and characteristics of these decisions. We reviewed new drugs and biologics evaluated by FDA advisory committees between 2007 and 2009 and found that half (27/52, 52%) were unapproved in the first cycle. By 2013, 63% had been approved. Products with initial safety concerns (62%) were much more likely to be approved eventually than drugs with efficacy concerns (8%).
Clinical Pharmacology & Therapeutics (2013); 94 6, 670–677. doi:10.1038/clpt.2013.165