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
2017.
- Senate tax bill will not make orphan drug tax credits transparent as to company, drug and disease. December 2, 2017.
- Senate proposes to cut Orphan Drug Tax Credit to 27.5 percent, and make it public November 29, 2017.
- KEI Comment on GOP proposal to eliminate the Orphan Drug Tax Credit November 2, 2017
- Kymriah, the Novartis $475,000 CAR T treatment, received 50 percent Orphan Drug tax credit on trials August 31, 2017
2016.
- FDA approves 45 new drugs. 47 percent qualify for 50 percent Orphan Drug tax credit January 5, 2016.
2014.
- Research note on oncology drugs, including trial size and orphan drug status November 17, 2014.
2011.
- Note on use of Orphan Drug Act to increase price of hydroxyprogesterone caproate from $10 to $1,500 per dose March 22, 2011.
2010.
- Notes and data points for prices of orphan products August 4, 2010.
- Transparency, cost benefit analysis and de-linkage of cost of R&D from price of the products for Rare and Neglected Pediatric Diseases August 4, 2010.
2001.
- Costs of Human Use Clinical Trials: Surprising Evidence from the US Orphan Drug ActNovember 28, 2001
1999.
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.