{ "docId": "019dd923-5ca1-7489-b639-45501f4b359b", "docSlug": "158df8627a0b9aca", "documentTitle": "Opioid Conflicts Majority Staff Report", "authorId": "McKinsey", "authorName": "U.S. House Committee on Oversight and Reform", "documentKindSlug": "consulting-deck", "documentKindLabel": "Consulting deck", "sourceTypeSlug": "strategy_consulting", "sourceTypeLabel": "Strategy consulting", "presentationDate": null, "orientation": "portrait", "aspectRatio": 0.773, "pageNumber": 21, "pageCount": 53, "prevPage": 20, "nextPage": 22, "slideType": "appendix_disclosure", "function": "appendix", "density": "dense", "nDataPoints": 0, "notes": "This appears to be a page from a formal report or legal document, containing footnotes and narrative text.", "elementsJson": [ "paragraph", "footnote" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-5ca1-7489-b639-45501f4b359b/21", "deckHref": "/decks/019dd923-5ca1-7489-b639-45501f4b359b", "deckJsonHref": "/decks/019dd923-5ca1-7489-b639-45501f4b359b.json", "deckAnchorHref": "/decks/019dd923-5ca1-7489-b639-45501f4b359b#slide-21", "components": [ { "bbox": null, "kind": "callout", "text": "McKinsey performed three contracts on the FDA Sentinel Initiative at the same time the company was consulting with opioid manufacturers on related issues, often with overlapping consultants, which increased the risk that FDA information might be shared with private sector clients.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd951-cdec-74db-b49b-0a14d4490f01", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.335, "w": 0.766, "x": 0.117, "y": 0.116 }, "kind": "paragraph", "text": "stakeholders\" including 17 FDA officials in the Office of Regulatory Affairs and five officials in CDER.90 Navjot Singh, who was also working with Mr. Smith on the FDA OSE contract, also appears to have informally advised McKinsey consultants serving private sector clients at this time, including Purdue. In February 2011, a McKinsey consultant emailed Mr. Singh stating that they were \"working through\" several \"FDA issues\" for a private sector client and added: \"Would be great to get the Regulatory pov [point of view] and expertise in the Purdue CST [client service team].\" Mr. Singh responded: \"Look forward to it. Depending on calendars 2 other[s] to include in the mix here are Jeff Smith and Pasha Saraf.\"91 Pasha Saraf was a key McKinsey consultant working for Purdue.92 It is unclear what \"FDA issue\" Mr. Singh offered his expertise on, or what other material he and the McKinsey consultants may have discussed on the call.93 On August 30, 2011, McKinsey was awarded a second contract by FDA to implement the new model governing OSE's portfolio. The second OSE contract, like the first, referenced REMS and CDER and OSE's responsibility over drug safety.94 Jeff Smith and Navjot Singh, along with two other McKinsey consultants, co-led this second engagement.95", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "7740ebf4-39f1-47d7-9eaa-792a97a8aa43", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.165, "w": 0.766, "x": 0.117, "y": 0.501 }, "kind": "paragraph", "text": "In 2008, FDA created the Sentinel Initiative to assess post-approval drug safety signals and \"monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices.\"96 Sentinel has since become \"a core component of the agency's evolving safety surveillance system,\" and \"Sentinel data have informed many regulatory decisions made by the Center for Drug Evaluation and Research.\"97 McKinsey performed three contracts on the FDA Sentinel Initiative at the same time the company was consulting with opioid manufacturers on related issues, often with overlapping consultants, which increased the risk that FDA information might be shared with private sector clients.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "de849a5c-2bfa-4531-be49-522ffd825928", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.205, "w": 0.766, "x": 0.117, "y": 0.698 }, "kind": "source-note", "text": "90-97 Footnotes detailing sources for the text.", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "c158a922-0bd3-43eb-b41a-11a4e011e65a", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.53, "x": 0.235, "y": 0.468 }, "kind": "title", "text": "ii. FDA Sentinel Contracts (2014-2018)", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "153072e0-d835-4703-a819-2a7b98685eab", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [ { "to": 28, "from": 6, "beatId": "ca9c3ab4-903c-4ff0-b53d-42335d2ce596", "arcName": "Problem-Agitate-Solution", "arcSlug": "problem-agitate-solution", "beatName": "Evidence & Proof", "beatSlug": "consultants-gambit-evidence-proof", "evidence": "The document presents extensive evidence of McKinsey's conflicts of interest, including consultant overlaps and contract details.", "position": 1, "confidence": 0.8, "parentBeatName": "Evidence", "parentBeatSlug": "evidence" } ], "loops": [ { "to": 53, "from": 1, "name": "Cost Of Inaction", "slug": "27-cost-of-inaction", "bestFor": "Urgent budget requests, compliance, risk mitigation", "matchId": "ee9686db-f8b5-4bc9-bf6e-2d29966ee033", "evidence": "The document implies the cost of inaction through its presentation of McKinsey's conflicts of interest and their potential impact on the opioid epidemic.", "position": 0, "objective": "What is the cost of inaction in addressing McKinsey's conflicts of interest?", "structure": "The Status Quo -> The Hidden Costs Accumulating -> The Future State of Inaction -> The Tipping Point", "confidence": 0.7, "description": "Quantify what happens if the audience does nothing" } ], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }