Drugs

Court Rules for FDA Against Informed Consent Changes

The DC District Court has ruled in FDA’s favor to dismiss a suit by the Center for Responsible Science (CRS) that sought new warnings on informed consent documents used in clinical trials. The lawsuit asked the court to force the agency to grant a CRS 6/2014 citizen petition on improved protections for human subjects in such studies. The petition asked that “FDA ensure every prospective trial participant receives the information necessary to evaluate the real risks posed by the drug trials in which they may participate so they can make an informed decision on whether or not to take part.”

According to a CRS statement at the time the lawsuit was filed, participants need to understand that the drugs they are being given have been tested largely in animal models, which are acknowledged by FDA to sometimes be unreliable predictors of human response, especially for new biologics coming to market. “Indeed,” the advocacy group said, “preclinical evaluation of human risk in animal experiments for biologics can be difficult, and sometimes impossible due to species-specific reactions, which can expose human subjects to unexpected, potentially catastrophic effects.”

FDA issued an interim response to the petition in 2014, saying it involved “complex issues requiring extensive review and analysis by agency officials,” CRS said. “However, even with the more than 150 clinical trial participant treatment-related deaths since CRS filed the petition, FDA recently provided just a brief response denying it. FDA’s response demonstrates that the agency has undertaken little, if any, review or analysis and has failed to address the serious concerns presented in the petition.”

While the court granted FDA’s request to dismiss the lawsuit based on plaintiffs’ lack of standing, it did give CRS 30 days to file an amended complaint.

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