Drugs

Senators Want Info on FDA Relationship with McKinsey in Opioid Crisis

Six senators are asking FDA for information on its work with McKinsey & Company and any potential conflicts of interest that may have arisen while the consulting firm was working for both FDA and opioid manufacturers such as Purdue Pharma. The 8/23 letter was signed by Sens. Edward Markey (D-MA), Maggie Hassan (D-NH), Chuck Grassley (R-IA), Sheldon Whitehouse (D-RI), Joe Manchin (D-WV), and Elizabeth Warren (D-MA).

“While working with FDA, McKinsey also worked for a wide range of actors in the opioid industry, including many of the companies that played a pivotal role in fueling the opioid epidemic that our country now faces,” the senators wrote. “Earlier this year, McKinsey settled claims with 49 state attorneys general that the company helped Purdue Pharma ‘turbocharge’ sales of OxyContin. McKinsey also consulted for opioid manufacturers Johnson & Johnson, Mallinckrodt, and Endo International as well as for major opioid distributors and retailers.”

The letter asks FDA acting commissioner Janet Woodcock to provide information on:

how the agency checks for conflicts of interest before, during, and after it awards a contract;
the agency’s current relationship with McKinsey and how many contacts have been awarded to the consulting firm since 2019, with a detailed description of each contract;
what conflict of interest disclosures McKinsey made when it was awarded contracts;
when FDA became aware that McKinsey had taken on opioid manufacturers as clients and whether such disclosures prompted a review of McKinsey’s existing contracts for conflicts of interest; and
when FDA became aware that McKinsey’s clients included several major opioid distributors and retailers and whether such disclosures prompted any review of existing McKinsey contracts for conflicts of interest.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome