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  "documentTitle": "Opioid Conflicts Majority Staff Report",
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      "text": "Under this strategy, McKinsey convinced Purdue to withdraw its own drug application for the original OxyContin, which it had promoted as safe for over a decade, based on alleged safety concerns. This, in turn, led FDA to investigate whether the old formulation of OxyContin, and all generic imitations, should be pulled from the market for safety reasons based on the original patent holder’s withdrawal.",
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      "text": "application for an abuse-deterrent formulation of OxyContin, withdraw its existing application for OxyContin “for reasons of safety” and thereby “Trigger an investigation by FDA for whether [the application] was pulled for safety; an affirmative finding results in withdrawal of all non-AD generics.”210 One presentation notes, “The value of the ADF strategy evaluated here is based on a strategy of ‘FDA conversion’: e.g. removal of non-AD generics from the market.”211",
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      "text": "A variation of this strategy appeared to work. On the day Purdue’s original patent for OxyContin was set to expire, FDA declared the benefits of OxyContin “no longer outweigh” the risks and limited generic competition.212 McKinsey described this as “FDA Conversion” of the market. McKinsey estimated the “Revenue upside to Purdue/Rhodes with market conversion could be $380-400M per year for ~3 years ($1.1B cumulatively).”213",
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      "text": "McKinsey recommended this strategy to Purdue despite unclear benefits of “abuse-deterrent” opioids and reformulated OxyContin in reducing addiction or abuse. In 2016, Dr. Tom Frieden, then-Director of the CDC, reported that his staff could not find “any evidence showing [abuse-deterrent formulations of opioids] actually reduce rates of addiction, overdoses, or deaths.”214 In 2020, the FDA released findings that “evidence was not robust that the reformulation caused a reduction in overall OxyContin abuse.”215",
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      "text": "210-215 Citations regarding McKinsey documents, Empire of Pain, and FDA/CDC reports.",
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