Content deleted Content added
Regulations (talk | contribs) |
Regulations (talk | contribs) |
||
Line 170:
All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted just two years later in 1987.<ref>http://www.fda.gov/fdac/special/newdrug/speeding.html FDA report on accelerated approval process</ref> Three of the first five drugs targeting HIV were approved in the United States before they were approved in any other country.<ref>http://www.fda.gov/bbs/topics/NEWS/NEW00519.html FDA press release on 3TC approval</ref> However, though in recent years the FDA has implemented a "fast track" for what are seen by them as high priority drugs, it still averages 12-15 years to bring a new therapy to market.<ref>Becker, Gary. [http://www.aei.brookings.org/policy/page.php?id=184 Power to the Patients]. AEI-Brookings Joint Center Policy Matters 04-15. Originally published in The Milken Institute Review, 2nd quarter 2004.</ref>
A national survey of neurologists and neurosurgeons in 1998 (after the passage of the FDA Modernization Act of 1997) revealed that 67% of them believe that the FDA takes too long to approve new drugs and medical devices. 73% of them believe that unapproved drugs and devices should be made available to them provided there is a warning lable indicating the unapproved status. 58% agree that the approval process costs lives. 80% of them say that on at least on occation that the approval process has prevented them from treating their patients with the best possible care. 73% of them say that the public has little or no understanding of the tradeoffs and human toll involved in the lengthy approval process.<ref>[http://www.cei.org/utils/printer.cfm?AID=1586 A National Survey Of Neurologists And Neurosurgeons Regarding The Food And Drug Administration, Executive Sumamary]. Competitive Enterprise Institute. Full Study in Adobe PDF form: [http://www.cei.org/pdf/1586.pdf A NATIONAL SURVEY OF NEUROLOGISTS AND NEUROSURGEONS REGARDING THE FOOD AND DRUG ADMINISTRATION], prepared by The Polling Company</ref>
====Criticism: FDA regulations disallow drug reimportation====
|