Drugs

Investigate FDA Role with Biogen on Alzheimer’s Drug: Public Citizen

Public Citizen is calling on the HHS Inspector General to “investigate the unprecedented and inappropriate close collaboration between FDA and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab.” In a 12/9 letter, the advocacy group says that after two identical Phase 3 trials of the drug were stopped at the halfway point because a preliminary analysis found that they were unlikely to show the drug benefited Alzheimer’s patients, FDA and Biogen worked collaboratively to salvage the drug.

“They jointly relied on dubious analyses that over-emphasized the results of one Phase 3 trial suggesting the drug may work at a high dose, but disregarded data from the other Phase 3 trial showing no benefit of the drug at any dose,” a Public Citizen statement says. “FDA and Biogen co-authored an unprecedented joint briefing document on aducanumab that was heavily biased in favor of the drug.”

The letter says that by collaborating with Biogen, FDA “dangerously compromised its objectivity and independence during the review process for aducanumab.”

Public Citizen says that an agency statistician wrote a “scathing critique” of the analyses conducted collaboratively by the agency and the company and also said that an FDA advisory committee “harshly criticized” the analyses of clinical trial data conducted by FDA and Biogen. Ten out of 11 committee members opposed approving the drug, it says.

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