McKinsey never told the FDA it was working for both the FDA and opioid makers

No concern that what they got caught for in South Africa might not have been a one-time deal. It’s “we explicitly understand you’re working with pharma companies whose interests may differ from ours but that these teams will be isolated and thus under no conflict of interest”. I can say with some confidence that nobody involved in the agreement, on either side, would be surprised by this article’s findings. And I am assuming that there is sufficient nuance around the concept of “appearance of conflict of interest” is covered by the mutual understanding of the firm’s internal controls.

McKinsey’s failure to disclose its industry engagements deprived the FDA of the opportunity to consider whether, for example, the overlap between McKinsey’s government and pharmaceutical industry projects and the potential financial incentives at play constituted a conflict, experts said. A number of other McKinsey projects at the FDA, contracting records show, were also likely to have a financial impact on its pharmaceutical industry clients. The top executive for global consulting firm McKinsey & Company faced congressional questions Wednesday about the company’s work for U.S. health regulators even as it advised opioid drugmakers on how to boost sales of their prescription painkillers. The timing question is becoming a bit more clear, as is the question of how much value may be created by the global launch of successful vaccines against COVID-19. Based on the established set of facts, experts agree a vaccine for COVID-19 is likely to be available somewhere between the fourth quarter of 2020 and first quarter of 2021, most likely for use in specific populations, with additional candidates coming on line by the end of 2021.

In addition to ensuring that the adaptations made today will be relevant in the future, that strategy will likely make the trickle-down effects for broader preparedness become more clear. Investments made now may create opportunities for greater preparedness for future pandemics and affect the ability to onboard capacity for new vaccine technologies and platforms when they might be needed. In the near term, COVID-19 vaccines would prevent more people from becoming infected and dying. The second-order effects include tanabaexo onlyfans controlled utilization of hospitals and healthcare resources, the development of herd immunity, and gradual economic recovery. In the midterm, if COVID-19 were to become endemic, the presence of a vaccine would allow the broader population to be inoculated . And if the disease mutates or immunity is short lived, the additional development and manufacturing capacity currently being established could be applied quickly to increase vaccine supply, create new vaccines, and accelerate the response to future pandemics.

What isn’t up for debate is that business leaders, governments, and policy makers will need to continually monitor and respond to those exogenous factors. Vaccine manufacturers have announced cumulative capacity that could produce as many as one billion doses by the end of 2020 and nine billion doses by the end of 2021. Regulatory bodies are still finalizing guidelines for COVID-19 vaccines. Recent guidance from the US Food and Drug Administration , for example, suggests the need for more data prior to granting Emergency Use Authorizations .

Congressional investigators found examples of McKinsey touting its FDA connections when soliciting consulting business from drugmakers. The company also submitted advice on dealing with the opioid epidemic to members of the Trump administration, including former Health and Human Services Secretary Alex Azar, according to the report. Sternfels told the committee that McKinsey’s FDA contracts focused on “organizational support,” and did not pertain to opioids or drug “safety standards.” He also pointed to multiple examples where McKinsey disclosed its work for opioid drugmakers to the FDA. The report, written by the panel’s Democratic majority, suggests McKinsey’s work “appears potentially” to have violated federal contracting rules that require disclosing potential conflicts of interest.

Obviously it’s because the drug manufacturers hired McKinsey themselves. I don’t think you’re wrong, but, as part of their contract that requires them to divulge potential conflicts of interest, why didn’t they just notify the FDA that they have separate teams that are working with Purdue and J&J? That would have satisfied the contract, and everyone already knows they have their fingers in everything everywhere, so there would have been no issue. No, they were hoping that this information would never come to light, and they wouldn’t have to say anything about it. They’ll still likely not face any sort of accountability for this.

Comments are closed.