Drugs

Groups Want Stronger Post-Market Trial Enforcement

More than 35 health experts and advocacy groups including U.S. PIRG (Public Interest Research Group) are calling on the Senate HELP Committee to include stronger enforcement of post-market clinical trials for accelerated approval drugs in its coming markup of draft FDA user fee legislation. U.S. PIRG says its letter indicates that drug companies have not consistently started or completed their required post-marketing trials, meaning that “too many products have lingered on the market and potentially endangered patients who continue to take these medications.”

The groups recommend these changes:

manufacturers complete their post-market studies to confirm a drug’s predicted clinical benefit;
FDA automatically remove from the market drugs approved through the accelerated approval pathway that have not demonstrated they offer clinical benefit after five years; and
FDA require that clinical trials be already underway when an approved drug comes to market to lessen the time between approval and the end of the full clinical trial.

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