Drugs

House Probes FDA/McKinsey Conflicts of Interest

Congressional interest in FDA’s consulting contracts with McKinsey & Co. continues to grow as the House Oversight and Reform Committee has requested details about the company’s role in advising opioid maker Purdue while also advising FDA on its regulatory actions involving opioids. The committee’s probe mirrors an August investigation (see earlier story) by Senate lawmakers who also sought details on any potential conflicts of interest that may have arisen while McKinsey was working for both FDA and opioid manufacturers such as Purdue Pharma

In an 11/5 letter to McKinsey, House members cited the potential for significant conflicts in its arrangement with FDA. Since 2008, FDA has paid McKinsey over $140 million, including $40 million from CDER, which oversees numerous opioid-related programs. “Purdue Pharma’s records show that at the same time McKinsey was advising FDA, including offices responsible for opioid programs, the company was also advising Purdue on how to lobby FDA,” the committee’s letter says.

Of particular interest, the letter says that in 2008 FDA proposed new safety rules for OxyContin under the agency’s Risk Evaluation and Mitigation Strategies program. “Purdue Pharma opposed the safety measures and, according to documents that have been made public, viewed defeating them as necessary to ‘save the business,’” it says. “As a result, they requested McKinsey’s assistance. Even though McKinsey was already consulting for FDA at the time, the firm proposed that the opioid industry ‘band together’ to ‘defend against strict treatment by the FDA.’”

Despite the potential conflicts of interest, McKinsey never disclosed its pharmaceutical company clients to FDA, according to the letter. FDA said it first became aware of McKinsey’s work for these companies ‘in early 2021 when the information was reported in the media,’” the letter says.

It requests a list of all McKinsey domestic clients and a description of each project conducted for the client since 2010. It also requests details on how the company manages potential 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

Read more

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