Orphan Drug - Orphan Drug Legislation

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:

    A man should not go where he cannot carry his whole sphere or society with him,Mnot bodily, the whole circle of his friends, but atmospherically. He should preserve in a new company the same attitude of mind and reality of relation, which his daily associates draw him to, else he is shorn of his best beams, and will be an orphan in the merriest club.
    Ralph Waldo Emerson (1803–1882)

    Upon entering my vein, the drug would start a warm edge that would surge along until the brain consumed it in a gentle explosion. It began in the back of the neck and rose rapidly until I felt such pleasure that the world sympathizing took on a soft, lofty appeal.
    Gus Van Sant, U.S. screenwriter and director, and Dan Yost. Bob Hughes (Matt Dillon)

    The laboring man and the trade-unionist, if I understand him, asks only equality before the law. Class legislation and unequal privilege, though expressly in his favor, will in the end work no benefit to him or to society.
    William Howard Taft (1857–1930)