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

Simon J Gunter; Aaron S Kesselheim; Benjamin N Rome

doi:10.1001/jamainternmed.2021.1989

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

JAMA Intern Med. 2021 Aug 1;181(8):1124-1126. doi: 10.1001/jamainternmed.2021.1989.

Authors

Simon J Gunter^{1

2}, Aaron S Kesselheim^{1

2}, Benjamin N Rome^{1

2}

Affiliations

¹ Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
² Harvard Medical School, Boston, Massachusetts.

Abstract

This cohort study assesses the long-term associations of the US Food and Drug Administration Unapproved Drug Initiative with market exclusivity characteristics and price changes.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Drug Approval* / methods
Drug Approval* / organization & administration
Drug Costs / legislation & jurisprudence
Drug Industry* / economics
Drug Industry* / legislation & jurisprudence
Drugs, Generic / economics
Economic Competition*
Humans
Orphan Drug Production
United States

Substances

Drugs, Generic