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- W2126676723 abstract "We test several explanations for the commonly observed pattern that larger firms receive shorter FDA approval times for the drugs they submit. Candidate explanations include capture and rent-seeking and “external-signals” accounts. Analyses of 766 new molecular entities submitted to the FDA from 1979 to 2000 suggest that large-firm advantage in pharmaceutical regulation is primarily due to two factors: (1) enhanced regulator familiarity with large firms by virtue of their submission histories (an effect augmented when firms merge), and (2) regulatory favor for “early entrants” to a disease market, which is induced from disease-specific consumer pressure for approvals. Our analyses show that as much as 70% of observed large-firm advantage in expected FDA approval times can be attributed to these factors, 30-55% to familiarity alone. We find no consistent support for rent-seeking or “political clout” explanations." @default.
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- W2126676723 date "2004-01-01" @default.
- W2126676723 modified "2023-09-23" @default.
- W2126676723 title "Why Do Bigger Firms Receive Faster Drug Approvals" @default.
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