“Unapproved Drugs Initiative”的意思、由来-开放百科全书

词条

Unapproved Drugs Initiative

释义

Drugs affected
References

Unapproved Drugs Initiative is a program by the U.S Food and Drug Administration announced in June 2006 to remove unapproved drugs from the market.^[1]{{As of |October 2011}} some 14 categories of drugs have been affected.^[2]

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.^[3] URL Pharma posted a detailed rebuttal of the NEJM editorial.^[4]

Drugs affected

Colchicine, (pill price rose from $0.09 to $4.85)
Ergotamine
Albuterol
many others^[2]

References

1. ^{{cite web |url=http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118990.htm |title=Unapproved Drugs Initiative (fda.gov)}}
2. ^¹{{cite web |url=http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm |title=Enforcement Actions by Drug Class }}
3. ^{{cite journal |author=Kesselheim AS, Solomon DH |title=Incentives for drug development--the curious case of colchicine |journal=N. Engl. J. Med. |volume=362 |issue=22 |pages=2045–7 |date=June 2010 |pmid=20393164 |doi=10.1056/NEJMp1003126 |url=http://content.nejm.org/cgi/content/short/362/22/2045}}
4. ^Response from URL Pharma

1 : Food and Drug Administration

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