McKinsey’s Push For Class-Wide Opioid REMS Among Actions Targeted In Opioid Settlement
Consulting firm agrees to turn over tens of thousands of documents detailing its advice to Purdue, J&J, Endo and Mallinckrodt and pay $537m as part of a deal with 47 states.
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House Oversight Committee members grill McKinsey global managing partner about whether the firm told FDA about its simultaneous work for opioid maker Purdue. Agency says it does not anticipate future contracts with McKinsey until investigations are completed.
A House Oversight and Reform Committee report says McKinsey consultants advised the FDA on modernization of its new drugs regulatory program, the Sentinel Initiative, and other projects at the same time it was working for opioid manufacturers on related topics; agency says McKinsey did not inform it of potential conflicts of interest.
Vaccine Technologies: US FDA Isn’t Afraid Of Needle-Free Delivery, But It Takes Time To Develop, Woodcock Says
The agency is interested in alternative formulations for COVID-19 inoculations, but pushed the traditional injection presentation because it was easier to develop quickly.