Unapproved Drugs Initiative
Encyclopedia
Unapproved Drugs Initiative is a programme by the U.S Food and Drug Administration
announced in June 2006 to remove unapproved drugs from the market.
some 14 categories of drugs have been affected.
It has been controversial due to the resulting increase in some drug prices.
In April 2010, in an editorial in the New England Journal of Medicine
(NEJM), A.S. Kesselheim and D.H. Solomon said that the rewards of this legislation are not calibrated to the quality or value of the information produced, that there is no evidence of meaningful improvement to public health, that it would be much less expensive for the FDA or National Institutes of Health
to pay for trials themselves on widely available drugs such as colchicine, and that the cost burden falls primarily on patients or their insurers. URL Pharma posted a detailed rebuttal of the NEJM editorial.
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
announced in June 2006 to remove unapproved drugs from the market.
some 14 categories of drugs have been affected.
It has been controversial due to the resulting increase in some drug prices.
In April 2010, in an editorial in the New England Journal of Medicine
New England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
(NEJM), A.S. Kesselheim and D.H. Solomon said that the rewards of this legislation are not calibrated to the quality or value of the information produced, that there is no evidence of meaningful improvement to public health, that it would be much less expensive for the FDA or National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
to pay for trials themselves on widely available drugs such as colchicine, and that the cost burden falls primarily on patients or their insurers. URL Pharma posted a detailed rebuttal of the NEJM editorial.
Drugs affected
- ColchicineColchicineColchicine is a medication used for gout. It is a toxic natural product and secondary metabolite, originally extracted from plants of the genus Colchicum...
, (pill price rose from $0.09 to $4.85) - Ergotamine
- many others