McKinsey's Overlapping Work For FDA, Opioid Makers Raises Conflict Of Interest Questions
Executive Summary
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.
You may also be interested in...
Will US FDA Change Its Conflict Of Interest Policies In Wake Of McKinsey’s Work With Purdue?
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.
US FDA’s New ‘Integrated’ Review Process Starts To Win Over Skeptics, But Industry Still Wants More Details
In an interview with the Pink Sheet, implementation director Rhonda Hearns-Stewart says FDA has modified the template for its 'integrated assessment' of marketing applications in response to feedback from reviewers and sponsors.
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.