Drugs

Patient Groups’ Expanded Access Principles

Seven patient advocacy groups — Alliance for Aging Research, American Cancer Society Action Network, Friends of Cancer Research, Leukemia and Lymphoma Society, National Organization for Rare Disorders, Parent Project Muscular Dystrophy, and St. Baldrick’s Foundation — say it is “imperative that patients seeking expanded access to unapproved therapies be treated with the same ethical standards and protections as patients taking part in clinical trials.” The groups’ statement says they support the process by which patients with serious diseases that have no options for effective treatments and who do not qualify for clinical trials have been able to access unapproved therapies through the expanded use of the compassionate use process.

They point out that unapproved therapies have not been shown to be safe and effective and thus there is a strong set of patient protections in place for clinical research to ensure safe and ethical use of the therapies.

“We urge drug sponsors to be as inclusive as possible with their clinical trials to reduce the need for patients to seek access to unapproved therapies outside of clinical trials,” the statement says. “When trial participation is not an option for seriously ill patients, and expanded access is sought, review by an institutional review board and FDA is essential to allow an informed third-party to ensure that use of the unapproved therapy is ethically and scientifically sound.”

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