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How McKinsey used its FDA connections to help opioid manufacturers: New congressional report Endpoints News

If you’re concerned that a loved one could be exposed to fentanyl, you may want to buy naloxone, a medicine that can rapidly reverse an opioid overdose and is often available at local pharmacies without prescription. Prescription drugs sold online or by unlicensed dealersmarketed as OxyContin, Vicodin and Xanax are often laced with fentanyl. “For a contractor like McKinsey not to disclose the companies it is working for has all the appeal of the Addams Family on Halloween hiding Uncle Fester in the basement so as not to scare the neighborhood,” said Charles Tiefer, a professor of government contracting at the University of Baltimore Law School. Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes. But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted. Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it’s free.

Vaccine innovators are already factoring manufacturing decisions into their development processes much earlier than they ever have. As noted, several manufacturers have announced capacity plans that total about one billion doses by the end of 2020 and eight billion to nine billion doses by the end of 2021. In the near term, COVID-19 vaccines would prevent more people from becoming infected and dying. The second-order effects include 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.

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 most scenarios, a vaccine will serve as a means to ensure immunity in broader populations. At a minimum, continued investment in vaccines can serve as a critical insurance policy needed to expedite the move to the next normal.

Additional documents suggest that McKinsey’s work for the agency, including by Dr. Smith, was even more extensive. Jeff Smith, a partner with the influential consulting firm McKinsey & Company, accepted a highly sensitive assignment in December 2017. The opioid manufacturer Purdue Pharma, beleaguered and in financial trouble, wanted to revamp its business, and an executive there sought out Dr. Smith. The firm let consultants advise both drugmakers and their government overseers, internal records show. The news of McKinsey’s opioid work apparently did little to dampen the FDA’s enthusiasm for the consultancy. In March 2019, just after the news broke, the agency signed a new contract with McKinsey — extending the firm’s multiyear effort to help the FDA “modernize” the process by which it regulates new drugs.

They all remain daunting challenges for the largest-ever public-health intervention in history. Some COVID-19-vaccine manufacturers have aggressively partnered to ramp up their production capacities across geographies. Technology transfer at the required scale and in such a compressed time frame is complicated, and it’s far from a done deal that it will work as intended. Governments, manufacturers, nongovernmental organizations, and others will need to deploy creative solutions to resolve issues or bottlenecks—for instance, by creating a knowledge-management infrastructure and applying digital tools and advanced analytics to technology transfers.

He will also point to examples where McKinsey disclosed its work for opioid drugmakers to the FDA. Senator Hassan responded that relying on contractors to self-report conflicts of interest is not sufficient. Earlier this year, Senator joined her colleagues in introducing bipartisan legislation to require federal agencies to assess and update yoplait 100 ways for a chance their procedures for determining whether contractors have a conflict of interest. The early data on vaccine safety and immunogenicity in Phase I and II trials are promising—although in a limited number of subjects to date. Additionally, it remains to be seen how long the protection from COVID-19 achieved by the vaccines will last.