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The Prescription Opioid and Heroin Epidemic and the FDA
FDA: ThalidomideFDA: OxyContinFDA: VicodinFDA: ZohydroFDA: AddictionFDA: Big PharmaFDA: Pediatric OxyContin FDA vs. CDC, Dec 2015
FDA: Big Pharma

     The controversial "enriched enrollment" methodology for testing the efficacy of prescription opioids was developed in meetings of IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials), an organization developed by two scientists and including representatives from the pharmaceutical industry and the FDA. 
     On Oct. 6, 2013, the Washington Post reported that while there was no charge to the FDA, companies in the pharmaceutical industry paid up to $25,000 to have their representatives attend any given meeting, presumably for the opportunity to affect the thinking of the FDA.  
     This incident is just the latest among many involving close collaboration between the FDA and industry.  There has also been a great deal of concern about how many FDA officials are drawn from industry and how many go on to positions working for industry or helping industry in its dealings with the FDA.
     The extent to which close collaboration between the regulators and those regulated has contributed to the FDA's policy failures regarding the problems of prescription opioid addiction and overdose death is impossible to assess, but there are many who think that the FDA's relationship with industry is too close for comfort. 


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