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Ever since the passage of the Orphan Drugs Act of 1983, a total of 2,992 drugs have received orphan designation by the FDA. Orphan designation basically means that less than 200,000 people suffer from the disease for which there is no effective treatment. Of those 2,992 orphans, 457 have been christian louboutin heels sale
approved. That's 15%, which is 1.5x higher than the overall approval rate for all drugs that make it to phase 1, christian louboutin booties sale
which is 9.5%. In short, receiving orphan status mitigates risk christian louboutin sales shoes for investors, and it also expedites the approval process. The average time from granting of orphan status until approval is 4 years. The average for all drugs is over 8 years, christian louboutin shoes sale outlet
12 if you count preclinical.
The Orphan Drugs Act, in my opinion, is quite misunderstood as being necessary for drugs that would otherwise be unprofitable. While that is true in a sense, it is mostly because the government so heavily regulates the drug development industry that barreling through that iron wall of regulation for a disease indication with few patients is what's unprofitable, not developing the drug itself and selling it absent the regulation. Most of what the Orphan Drugs Act does is simply lower the regulatory burden just a bit for certain drugs and the companies pursuing them. It's something akin to a school bully promising to steal less lunch money from people who suffer from rare food allergies. Praising the bully for his magnanimity in taking less money from these kids seems a bit out of place.
In some cases government grants are given for orphan drug development, but this is not a major aspect of the legislation.
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