For background on the Fabrazyme case, see: https://www.keionline.org/fabrazyme
The following statements were made today by civil society on the NIH rejection of the Fabrazyme March-in Request Petition. Contact Judit Rius at judit.rius@keionline.org if your organization would like to submit an statement.
Statement by James Love, Director of Knowledge Ecology International (KEI) (Contact: 1.202.361.3040)
From the FDA page on the Orphan Drug Tax Credit. Incentives TAX CREDIT (See Footnote 1 below) FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR CONDITIONS Introduction Section 45C of the Internal Revenue Code of 1954 allows a credit… Continue Reading
From the FDA page on the Orphan Drug Tax Credit.
IncentivesTAX CREDIT
(See Footnote 1 below)
FOR TESTING EXPENSES FOR
DRUGS FOR RARE DISEASES OR CONDITIONSIntroduction
Section 45C of the Internal Revenue Code of 1954 allows a credit against tax, up to 50 percent of certain clinical testing expenses related to the use of a drug for a rare disease or condition after it is designated as an orphan drug.Transparency, cost benefit analysis and de-linkage of cost of R&D from price of the products for Rare and Neglected Pediatric Diseases
Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures On the topic of Transparency, cost benefit analysis and de-linkage of cost… Continue Reading
Costs of Human Use Clinical Trials: Surprising Evidence from the US Orphan Drug Act
James Love Michael Palmedo Consumer Project on Technology http://www.cptech.org November 28, 2001 Summary According to the US Internal Revenue Service (IRS), US taxpayers received Orphan Drug Tax Credits totaling $80.1 million in fy 1998, and $61.4 million in fy 1997,… Continue Reading
Brief note on the abuse of Orphan Drug programs in creating monopolies
CPT has been highly critical of the exclusive marketing provisions in the US and the proposed EU orphan drug acts. Pharmaceutical companies now obtain 20 year patents for inventions, and investments in clinical trials and other research required for drug… Continue Reading
Call for More Reliable Costs Data on Clinical Trials
Call for More Reliable Costs Data on Clinical Trials James Love January 13, 1997Abstract The following is an article titled “Call for More Reliable Costs Data on Clinical Trials,” Published in the January 13, 1997 issue of the Marketletter, on… Continue Reading
Excerpts from “Comments on the Orphan Drug Act and Government Sponsored Monopolies for Marketing Pharmaceutical Drugs.”
(More on this topic here: https://www.keionline.org/orphan-drugs and here.) This is from: 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… Continue Reading