Unapproved Drugs Initiative is a program by the U.S
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
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
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
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.
Response from URL Pharma
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Drugs affected
* Colchicine, (pill price rose from $0.09 to $4.85)
* Ergotamine
*Albuterol
Salbutamol, also known as albuterol and sold under the brand name Ventolin among others, is a medication that opens up the medium and large airways in the lungs. It is a short-acting β2 adrenergic receptor agonist which works by causing rel ...
*many others[
]
References
Food and Drug Administration
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