Drugs

FDA Neuroscience Deputy Bastings Retires, Joins Ionis

After 20 years at FDA, CDER Office of Neuroscience deputy director Eric Bastings has retired and joined Ionis Pharmaceuticals as vice president of development strategy. Bastings’s retirement comes at a difficult time for the Office of Neuroscience, which oversaw last year’s controversial approval of Biogen’s Alzheimer’s therapy Aduhelm (aducanumab-avwa). At Ionis, Bastings will “provide senior clinical and regulatory leadership in support of Ionis' goal to bring transformational medicines to the market,” the company says.

Bastings has a medical degree from the University of Liege in Belgium, where he also completed his neurology residency. At FDA, Bastings provided strategic and clinical oversight of five review divisions and led scientific and regulatory activities. In this role, he evaluated the design of human trials supporting development programs for investigational new drugs, and the safety and effectiveness of drugs across all neuroscience therapeutic areas (NDAs, BLAs, and supplements), according to Ionis.

Amid the fallout and criticism of Biogen’s Alzheimer’s approval and subsequent protest resignations of three advisory committee experts (see story), FDA acting commissioner Janet Woodcock asked the HHS inspector general to “conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm.”

In a 7/9 letter posted on Twitter, Woodcock said: “We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures.”

And Public Citizen has called for Woodcock, CDER director Patrizia Cavazzoni, and CDER Office of Neuroscience director Billy Dunn to resign or be dismissed over what the advocacy group calls the “reckless approval of aducanumab for Alzheimer’s.” A Public Citizen statement last year questioned new disclosures in a detailed exposé published by STAT about how Biogen used an FDA back channel to win approval for aducanumab. “The circumstances described in the STAT exposé, if confirmed, paint a damning picture of drug regulators who surrendered their independence and objectivity, essentially began working on behalf of Biogen, and fostered regulatory capture at the agency,” the advocacy group said.

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