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Reviews |  Congress needs to ask how much McKinsey harmed the FDA

Second, has the company shared specific details about FDA processes and plans with Purdue Pharma? The Congressional report shows that McKinsey apparently presented itself to opioid makers as having “developed insights into the outlook for regulators themselves.” The company also told Purdue that it offers “unparalleled capability based on who we know and what we know.” It is important to understand how McKinsey responded to these requests.

Finally, do these concerns extend beyond opioids? I certainly wish that in 2010 I had challenged the FDA’s $50 million global purchase agreement for McKinsey services over the next five years. Under the agreement, FDA officials would continue to use McKinsey to advise them on tasks related to overseas inspections and generic drug reviews. In 2017, the FDA signed another $49.5 million global purchase agreement, under which McKinsey helped modernize core processes for 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 with each of the top 20 pharmaceutical companies.

In its response to the report, the company said, “We did not advise the FDA on regulatory decisions or on specific drug products.” The FDA also said its contracts with McKinsey involved internal issues and “did not include work on specific drug products or product classes, including opioids.” These responses, however, ignore the obvious concern that the company’s work on FDA management structure and processes may have indirectly affected many regulatory actions.

During my time at the FDA, I have gained great respect for its scientists and leaders, who are themselves subject to strict prohibitions on receiving outside revenue and take tremendous pride in the independence of their agency. I’m sure many are troubled by the revelations in the Congressional report. Some may also believe that McKinsey’s work, on the whole, has helped the agency. However, even evidence of a benefit to the FDA would not excuse McKinsey for brokering its relationships or using its internal understanding to help clients like Purdue Pharma.

After Wednesday’s hearing, Congress is expected to continue investigating whether McKinsey abused the trust of the FDA. Bipartisan legislation was introduced to promote greater transparency in the government’s use of contractors. Congress should also, at a minimum, prohibit individual consultants from companies like McKinsey from working for agencies and regulated companies at the same time, and require firewalls to block information sharing between public and private sector branches. consulting firms, with heavy penalties for violations.

For its part, the FDA should fully cooperate with Congress, share all relevant documents and participate in interviews. But the agency should not stop there. As it has done in the past to learn from the scandal, the FDA should conduct its own candid assessment of McKinsey’s conflicts of interest and use the lessons to strengthen its internal policies. By doing so, the agency can demonstrate its resilience and ensure that this threat to its integrity does not happen again.

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