Orphan Drugs

Orphan Drug Timeline

Data from Orphan Drug Tax Credit

2017. What does the Orphan Drug Tax Credit tell us about the Costs of Clinical Trials? Bill of Health. November 15.

From 2010 to 2016, the average qualifying trial costs claimed for the orphan drug credit was $86 million to $102 million, per FDA approved orphan indication . . .

2017. Orphan Drugs Designations and Approvals have Something to Say about Risks, Bill of Health, September 25.

. . .since 2010, the average time from orphan designation to approval is 5.3 years, and the likelihood of FDA approval for an orphan indication, which varies over time and across business cycles, was .22 from 1990 to 2017, and since 2010, was .25.

1997. Call for More Reliable Costs Data on Clinical Trials, The Marketletter, January 13, 1997.

Selected blogs








Other Commentary

1992. “Comments on the Orphan Drug Act and Government Sponsored Monopolies for Marketing Pharmaceutical Drugs.” United States Senate, Committee on the Judiciary, Subcommittee on Antitrust, Monopolies and Business Rights, Anticompetitive Abuse of the Orphan Drug Act: Invitation to High Prices, January 21, 1992, Serial Number J-102-48, pages 259-283. Some excerpts from this here.