Drugs

FDA Worried About Biosimilar ‘Misinformation’

FDA commissioner Scott Gottlieb says he is “worried that there are deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of unbranded biologic drugs. In an interview with the Washington Post, Gottlieb says such messages “can potentially undermine consumer confidence in biosimilars in ways that are untrue.”

The Post reports that Gottlieb did not name specific companies or groups and said his agency could issue a Warning Letter to any drugmaker it finds is deliberately misleading the public about biosimilar safety. He said such messages “raise public health concerns. They could negatively impact a patient’s judgment about an otherwise safe and effective product.”

The report says the Alliance for Safe Biologic Medicines, described as part of a broad network of industry-funded groups trying to curb the spread of unbranded biologics, has raising safety concerns as a key strategy.

Alliance international advisory board chairman Philip Schneider, former associate dean of pharmacy at the University of Arizona, says the U.S. medical community should proceed cautiously in moving patients to unbranded biologics “so we don’t end up with another thalidomide” or “all the other things that happen when safety isn’t considered.” The Post says that warnings about hazards are also on the Alliance Web site.

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