Biopower: Foucault and Beyond by Vernon W. Cisney & Nicolae Morar

Author:Vernon W. Cisney & Nicolae Morar [Cisney, Vernon W. & Morar, Nicolae]
Language: eng
Format: epub
ISBN: 9780226226767
Publisher: University Of Chicago Press
Published: 2015-12-28T00:00:00+00:00

Notes

1. After reading the Los Angeles Times report of testimony on this bill, Jack Klugman and his brother Maurice decided to do an episode of Quincy about persons affected by rare diseases (Henkel 1999). This episode was incredibly popular and was followed by testimony from Jack Klugman and Adam Seligman in Congress in relation to a bill that was reintroduced by Representative Henry Waxman.

2. The Orphan Drug Act (ODA) provides a number of incentives to pharmaceutical and biotechnology companies to develop rare disease treatments. The greatest incentive consists of seven years of market exclusivity. Under the terms of this provision, the FDA cannot license any other drug or product for the same indication, with the exception of products that demonstrate a greater safety profile or clinical effectiveness. The ODA provides tax credits for up to 50 percent of clinical trial–related expenses. Another incentive consists of the waiver of application fees relating to new drug applications (application fees are in the region of $500,000). To encourage the development of treatments for rare diseases, sponsors of a drug can request written protocol assistance from the FDA relating to the design of clinical trials that are most likely to satisfy the drug approval process. This provision was put in place since the conduct of clinical trials on small patient populations is often difficult and it is not always possible to conduct randomized control trials. In the United States, the ODA provides a number of research grants to encourage the development of orphan drugs or medical devices.

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