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# See if McKinsey Abused FDA Trust: Sharfstein
- URL: https://www.fdaweb.com/see-if-mckinsey-abused-fda-trust-sharfstein/
- Published: 2022-04-26T12:00:00.000Z
- Updated: 2026-09-14T17:42:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Drugs, #legacy-id-D5151683

Former FDA principal deputy commissioner **Joshua Sharfstein**, now a professor at the Johns Hopkins University Bloomberg School of Public Health, says Congress needs to be looking at the impact of the global consulting firm McKinsey working for FDA and Purdue Pharma simultaneously and whether the consultants abused FDA’s trust. Writing in a *New York Times* [guest essay](https://www.nytimes.com/2022/04/26/opinion/mckinsey-fda-opioids.html?ref=fdaweb.com), Sharfstein says that “independence from the companies that sell regulated products is essential to FDA’s effectiveness and credibility.”

He notes that while McKinsey was sending what one consultant called a “mini-army” to work for Purdue Pharma, it also was advising FDA on how to organize its offices overseeing the safety of opioids and other medications.

(McKinsey has said it did not have to disclose the dual assignments to FDA because its work with drug companies did not create a conflict of interest with its work for FDA.)

Sharfstein writes that the McKinsey global managing partner will testify at a 4/27 hearing before the House Committee on Oversight and Reform. At that hearing, he says, members of Congress should focus not only on what McKinsey did or did not disclose, but also on the impact the firm’s alleged duplicity may have had.

He poses three questions he hopes will be explored at the hearing: 

- whether McKinsey provided advice to FDA that was favorable to Purdue Pharma;
- whether McKinsey shared specific details of FDA processes and plans with Purdue; and

 whether the concerns about McKinsey’s actions extend beyond opioids.

“I certainly wish that in 2010 I had questioned FDA’s $50 million blanket purchase agreement for McKinsey services over the next five years,” Sharfstein writes. “Under this agreement, officials in FDA would go on to use McKinsey to advise on tasks related to foreign inspections and the review of generic drugs. In 2017, FDA signed another $49.5 million blanket purchase agreement, under which McKinsey helped to modernize the fundamental processes of reviewing new drug applications, among other tasks. These are projects with enormous implications for the entire pharmaceutical industry. One document includes McKinsey’s claim to have consulted for every one of the top 20 pharmaceutical companies.”

In its response to a damning congressional report, the consulting firm said, “We have not advised FDA on regulatory decisions or on specific pharmaceutical products.” And the agency said that the McKinsey contracts involved internal issues and “did not include work on specific drug products or product classes, including opioids.”

But, as Sharfstein points out, those responses “skip over the obvious concern that the firm’s work on FDA’s structure and management processes could have indirectly affected many regulatory actions.”

He notes that many agency staff are subject to strict prohibitions on receiving outside income and are fiercely proud of FDA’s independence. “I am sure that many are troubled by the revelations in the congressional report,” he writes. “Some may also believe that McKinsey’s work, on balance, helped the agency. Even evidence of benefit to FDA, however, would not excuse McKinsey if it traded on its relationships or used its inside understanding to assist clients like Purdue Pharma.”

Sharfstein calls on Congress to continue its probe beyond the hearing to determine whether McKinsey may have abused the agency’s trust. He also calls for passage of legislation to, at a minimum, prohibit individual consulting firms from working for agencies and regulated companies at the same time, and require firewalls to block the sharing of information between public and private sector arms of consulting companies, with strong penalties for violations.

And he calls on FDA to cooperate fully with Congress and also to conduct its own candid assessment of McKinsey’s conflicts of interest and use the lessons to strengthen its internal processes. “By doing so,” Sharfstein concludes, “the agency can demonstrate its resilience and make sure that this threat to its integrity does not happen again.”