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      "text": "McKinsey’s business relationships with opioid manufacturers appear to have posed significant organizational conflicts of interest for its consulting contracts with FDA—conflicts that are regulated and restricted by federal acquisition rules.",
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      "text": "C. McKinsey Failed to Disclose Serious Conflicts of Interest",
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      "text": "McKinsey consultants also highlighted the firm’s connections with other federal agencies to opioid manufacturers. For instance, in November 2008, McKinsey submitted a project proposal to Purdue titled “Maximizing profits from Tramadol OD,” a type of opioid. In that presentation, McKinsey outlined the extent of its health care consulting business, implying that its connections with payors, hospitals, and government agencies could help achieve fuller reimbursement for Tramadol. On one slide, titled “Examples of who we serve,” McKinsey stated that it possesses “[u]nique relationships with CMS officials, industry associations and government-sponsored programs (e.g., NHS, TennCare, SingHealth),” referring to U.S. and foreign government health programs.",
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      "text": "McKinsey does not appear to have disclosed any of these conflicts of interest to FDA.",
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      "text": "McKinsey’s business relationships with opioid manufacturers appear to have posed significant organizational conflicts of interest for its consulting contracts with FDA—conflicts that are regulated and restricted by federal acquisition rules and the terms of many of McKinsey’s FDA contracts. McKinsey’s organizational conflicts of interest were likely exacerbated by its routine practice of staffing consultants at FDA and opioid manufacturers on projects with related subject matters.",
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      "text": "1. Many of McKinsey’s FDA Contracts Required Disclosure of Potential Conflicts of Interest Pursuant to the Federal Acquisition Regulation",
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      "text": "FDA procurement activities are governed by the Federal Acquisition Regulation (FAR), which includes rules for agencies to avoid, neutralize, and mitigate organizational conflicts of interests (OCI). The FAR states:",
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      "text": "Organizational conflict of interest means that because of other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage.",
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      "text": "162 MCK-HCOR-0037100, Slide 18. 163 See 48 C.F.R. §§ 9.5 et seq. (commonly cited as Federal Acquisition Regulation (FAR) Subpart 9.5). 164 48 C.F.R. § 2.101.",
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