Drugs

Ex-FDA Court Expert Witness Challenged

The New Jersey federal court hearing the Proton-Pump Inhibitor Products Liability Litigation is considering a challenge to a former FDAer who was to appear as an expert witness. Attorney James Beck (Reed Smith) writes in a Drug & Device Law post that the witness was challenged under a federal conflict of interest statute. He says that may be the first time the law has been used to challenge an ex-FDA witness.

Beck says the witness was described as a former CDER Division of Nonprescription Clinical Evaluation director and team leader who had been intimately involved with proton-pump inhibitors and FDA’s approval of the drug in question for over-the-counter use. “It wasn’t exactly the same drug but it was close,” Beck writes, describing it as “the OTC version of a prescription drug at issue in the litigation.”

The post says the issue is yet to be resolved. Because FDA’s position on the question was not known, the court said the agency should be contacted and postponed a ruling on the motion to disqualify the witness pending hearing FDA’s position.

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