Drugs

Porter Wants OIG Probe of Company Influence on FDA

House government operations subcommittee vice chair Katie Porter (D-CA) says it is apparent from the controversial FDA 6/7 approval of Biogen’s Aduhelm (aducanumab) to slow the effects of Alzheimer’s disease that the drug industry continues to have an undue influence on FDA and HHS. In a 7/6 letter to the HHS Inspector General, Porter requests an immediate investigation of “the role that pharmaceutical industry executives, consultants, and lobbyists have in the approval of products by the Department of Health and Human Services and, specifically, in FDA. While families and patients deserve to have access to urgently needed treatments, the violation of well-established rules regarding communications between scientists and manufacturers and the subsequent misuse of approval and contracting pipelines is unacceptable.”

Porter reviews many of the aspects of the Aduhelm evaluation and approval that have been reported in the media and disclosed by Biogen and FDA and says “it appears very clear that Biogen had an inside route to FDA officials and had undue influence over their decision making and the evidence presented in various settings.”

She calls for a review of all agency practices in meeting with drug companies and affiliated entities to establish new internal policies to prevent fraud, waste, and abuse of the systems. Porter says patients and their families deserve to know agency decisions are made by independent scientists and not by companies with clear financial motivations for pursuing approval of inadequate treatments.

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