Market Exclusivity and Changes in Competition and Prices Associated With the US Food and Drug Administration Unapproved Drug Initiative

In 2006, the US Food and Drug Administration (FDA) launched the Unapproved Drug Initiative (UDI) to document supporting data for several thousand drugs that had remained on the US market continually since before the agency began reviewing safety and effectiveness in 1938.1 As an incentive, the FDA o...

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Veröffentlicht in:	Archives of internal medicine (1960) 2021-08, Vol.181 (8), p.1124-1126
Hauptverfasser:	Gunter, Simon J, Kesselheim, Aaron S, Rome, Benjamin N
Format:	Artikel
Sprache:	eng
Schlagworte:	Drug Approval - methods Drug Approval - organization & administration Drug Costs - legislation & jurisprudence Drug delivery systems Drug Industry - economics Drug Industry - legislation & jurisprudence Drugs Drugs, Generic - economics Economic Competition FDA approval Health Care Policy and Law Humans Letters Occupational safety Online First Orphan Drug Production Research Letter United States
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Beschreibung
Zusammenfassung:	In 2006, the US Food and Drug Administration (FDA) launched the Unapproved Drug Initiative (UDI) to document supporting data for several thousand drugs that had remained on the US market continually since before the agency began reviewing safety and effectiveness in 1938.1 As an incentive, the FDA offered market exclusivity to the first manufacturer to receive approval of a legacy drug.
ISSN:	2168-6106 2168-6114
DOI:	10.1001/jamainternmed.2021.1989