Drugs

Senators Want Consulting Firm Probed for Opioid Crisis

Seven senators have signed a letter calling for an investigation into the failure of the consulting firm McKinsey & Company to disclose potential conflicts of interest when the company was simultaneously working with FDA on issues related to opioids and for several opioid companies, including Purdue Pharma. The senators want the HHS Inspector General to look into FDA’s work with McKinsey and the agency’s contracting policies to ensure that contractors adequately disclose all potential conflicts of interest in the future.

“While working for clients involved in manufacturing, distributing, and selling opioids,” the senators wrote, “McKinsey simultaneously worked on projects for FDA, including projects for the FDA Center responsible for approving new drugs, like opioids. Government contracting databases show that since 2008, McKinsey has been hired by FDA on numerous occasions, earning more than $140 million.”

Previously, Sen. Maggie Hassan (D-NH) sought answers from FDA about McKinsey after media reports indicated the company did not reveal potential conflicts of interest to the agency while they were contracted to work for it.

FDA said it was unaware that McKinsey worked with Purdue Pharma until 2021 news stories broke. The senators wrote to the Inspector General that despite the media reports, “FDA did not conduct any additional contract reviews or discuss with McKinsey conflicts of interest and the firm’s failure to disclose them in earlier contact applications. Furthermore, it is unclear whether FDA has altered or improved its processes and procedures to prevent similar nondisclosures of conflicts of interest in future contracts.”

At the end of March, Sen. Gary Peters (D-MI), chairman of the Senate Homeland Security and Government Affairs Committee, introduced the Preventing Organizational Conflicts of Interest in Federal Acquisition Act to require federal contractors to disclose other business relationships with entities that conflict with the work that an agency like FDA has retained them to do.

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