Qutenza was passed by the FDA under the Orphan Drug Act:
http://www.checkorphan.org/grid/news...etic-neuralgia
What this means:
http://en.wikipedia.org/wiki/Orphan_drug
Quote:
...Nevertheless, some critics have questioned whether orphan drug legislation was the real cause of this increase (claiming that many of the new drugs were for disorders that were already being researched anyway, and would have had drugs developed regardless of the legislation), and whether the ODA has really stimulated the production of truly non-profitable drugs; the act also received some criticism for allowing some pharmaceutical companies to make a large profit off of drugs that have a small market but still sell for a high price.[2]
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. Free market advocates often respond that without government-mandated minimum safety and efficacy requirements, drug development costs would be considerably lower.
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).
|
I think this partially explains the high price of these patches.
__________________
All truths are easy to understand once they are discovered; the point is to discover them.-- Galileo Galilei
************************************
.
Weezie looking at petunias 8.25.2017
****************************
These forums are for mutual support and information sharing only. The forums are not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Always consult your doctor before trying anything you read here.