Add some hearings.. 1983 Oversight on implementation of the Orphan Drug Act (Public Law 97-414) : hearing before the Committee on Labor and Human Resources, United States Senate, Ninety-eighth Congress, first session, on reviewing the radioepidemiological tables and thyroid cancer… Continue Reading
(More on this topic here: https://www.keionline.org/orphan-drugs and here.) 1980 April 17, 1980. Congresswoman Elizabeth Holtzman introduces H.R.7089 (96th Congress) – “A bill to establish an office in the National Institutes of Health to assist in the development of drugs for… Continue Reading
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… Continue Reading
The 2010 Fabrazyme NIH Bayh-Dole march-in case https://www.keionline.org/cl/bayh-dole/fabrazyme The 2014 FTC complaint regarding collusion between Shire and Sanofi. https://www.keionline.org/22538
More on Fabry here: https://keionline.org/fabry NIH rejects Fabrazyme March-In Petition December 7, 2010. Press release from Fabry patients: DHHS denies patient’s march-in request to end Genzyme’s rationing of treatment for Fabry Disease citing that FDA rules block manufactures from supplying… Continue Reading
Contact: Kim Treanor 202-332-2670; firstname.lastname@example.org January 5, 2018 The National Institutes of Health (NIH) has proposed an exclusive license with Gilead for certain patent applications for inventions that target CD-30 proteins and CAR T technologies. The proposed license is to… Continue Reading
In a reversal from the version that passed out of the Senate Finance Committee, the version of the tax bill that passed the Senate eliminated the requirement that the Orphan Drug tax credit be transparent as to taxpayer, drug and… Continue Reading
The Managers Amendment for the “Tax Cuts and Jobs Act” is available on the Senate Finance web page here: https://www.finance.senate.gov/imo/media/doc/11.20.17%20Tax%20Cuts%20and%20Jobs%20Act.pdf I was looking over the Orphan Drug Tax Credit (ODTC) language. The earlier Senate Finance proposal was a more complex… Continue Reading
Statement by James Love, KEI Director, on GOP proposal to eliminate the Orphan Drug Tax Credit.
The GOP proposal to eliminate the Orphan Drug Tax Credit may create a new opportunity to reform the incentives for rare diseases, even if the tax bill fails or the tax credit survives. The GOP tax bill shows there is weaker support for the existing regime than many thought.
Missing in the reporting on the Novartis price for Kymriah, its new $475,000 CAR T treatment, is that Novartis received an Orphan Drug designation in February 3, 2015, and sequently received a tax credit subsidy from the United States equal to 50 percent of the cost of qualifying clinical trials.
From the FDA database on Orphan Designations: