Orphan Drug Legislation
Orphan drugs generally follow the same regulatory development path as any other pharmaceutical product, in which testing focuses on pharmacokinetics and pharmacodynamics, dosing, stability, safety and efficacy. However, some statistical burdens are lessened in an effort to maintain development momentum. For example, orphan drug regulations generally acknowledge the fact that it may not be possible to test 1,000 patients in a phase III clinical trial, as fewer than that number may be afflicted with the disease in question.
Since the market for any drug with such a limited application scope would, by definition, be small and thus largely unprofitable, government intervention is often required to motivate a manufacturer to address the need for an orphan drug. Critics of free market enterprise often cite this as a failure of free market economic systems.
The intervention by government on behalf of orphan drug development can take a variety of forms:
- Tax incentives.
- Enhanced patent protection and marketing rights.
- Clinical research financial subsidization.
- Creating a government-run enterprise to engage in research and development (see Crown corporation).
Read more about this topic: Orphan Drug
Famous quotes containing the words orphan, drug and/or legislation:
“The obvious parallels between Star Wars and The Wizard of Oz have frequently been noted: in both there is the orphan hero who is raised on a farm by an aunt and uncle and yearns to escape to adventure. Obi-wan Kenobi resembles the Wizard; the loyal, plucky little robot R2D2 is Toto; C3PO is the Tin Man; and Chewbacca is the Cowardly Lion. Darth Vader replaces the Wicked Witch: this is a patriarchy rather than a matriarchy.”
—Andrew Gordon, U.S. educator, critic. “The Inescapable Family in American Science Fiction and Fantasy Films,” Journal of Popular Film and Television (Summer 1992)
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—Maya Angelou (b. 1928)