Second, did the firm share specific details of F.D.A. processes and plans with Purdue Pharma? The congressional report shows that McKinsey apparently marketed itself to opioid manufacturers as having “developed insights into the perspectives of the regulators themselves.” The company also told Purdue that it offered “an unequaled capability based on who we know and what we know.” It’s important to understand how McKinsey delivered on these claims.
Lastly, do these concerns extend beyond opioids? I certainly wish that in 2010, I had questioned the F.D.A.’s $50 million blanket purchase agreement for McKinsey services over the next five years. Under this agreement, officials in the F.D.A. would go on to use McKinsey to advise on tasks related to foreign inspections and the review of generic drugs. In 2017, the F.D.A. 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 the report, the company stated, “We have not advised the F.D.A. on regulatory decisions or on specific pharmaceutical products.” The F.D.A. has also said that its contracts with McKinsey involved internal issues and “did not include work on specific drug products or product classes, including opioids.” These responses, however, skip over the obvious concern that the firm’s work on the F.D.A.’s structure and management processes could have indirectly affected many regulatory actions.
In my time at F.D.A., I gained great respect for its scientists and leaders, who are themselves subject to strict prohibitions on receiving outside income and are fiercely proud of their agency’s independence. I am sure that many are troubled by the revelations in the congressional report. Some may also believe that McKinsey’s work, on balance, helped the agency. Even evidence of benefit to F.D.A., however, would not excuse McKinsey if it traded on its relationships or used its inside understanding to assist clients like Purdue Pharma.
After the hearing on Wednesday, Congress should keep investigating whether McKinsey may have abused the F.D.A.’s trust. Bipartisan legislation has been introduced to promote greater transparency in the government use of contractors. Congress should also, at a minimum, prohibit individual consultants at firms like McKinsey 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.
For its part, the F.D.A. should cooperate fully with Congress, sharing all relevant documents and participating in interviews. But the agency should not stop there. As it has done in the past to learn from scandal, the F.D.A. 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 make sure that this threat to its integrity does not happen again.
