Drugs

Woodcock ‘Unfit’ to be CDER Director: Public Citizen

CDER director Janet Woodcock is “unfit to serve as CDER director,” Public Citizen Health Research Group director Michael Carome says in a Huffington Post blog posting. Her decision last month to approve Sarepta’s Duchenne muscular dystrophy drug eteplirsen while overruling several agency experts, “represents a dangerous, unparalled capitulation to pressure from politicians and patients and a stunning disregard of the scientific evidence,” Carome writes. “Her action eviscerates the FDA’s long-standing (but, under Woodcock, already declining) approval standards for new drugs, threatens public health....”

Carome’s post noted concerns from CDER Office of Drug Evaluation 1 director Ellis Unger about Woodcock’s involvement in the submission and his appeal to have her decision examined by FDA commissioner Robert Califf (see story). Unger characterized Woodcock’s involvement in the review of eteplirsen as “unprecedented,” including her extensive involvement in the planning of, and her participation in, a 4/25 advisory committee meeting. Unger also raised concerns about Woodcock’s issuance of her decision memo before he had finished his own decision memo on behalf of the team of FDA scientists who had conducted the review of the drug.

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