Drugs

FDA, FTC Advancing Biologic Competition

CDER director Patrizia Cavazzoni says FDA and the Federal Trade Commission (FTC) are working together to help advance competition for biologics, including biosimilars and interchangeable biosimilars. Writing in an online FDA Voices post, Cavazzoni says the agencies’ commitments were detailed in a 2/3/2020 joint statement. That was followed by a 3/2020 joint public workshop at which participants from industry, academia, and government agencies discussed competition in the biologics market. A summary report on that workshop was recently released.

“Since the workshop,” Cavazzoni says, “the agencies have worked together on issues such as exchanging information about how to combat activities that undermine competition and/or harm the public health. FDA and FTC share concerns about false or misleading information and their negative impacts on public health and drug companies.”

Cavazzoni says the two agencies have developed an educational resource for consumers about biosimilars and interchangeable biosimilars to help address common misperceptions. “Unwarranted concerns may discourage patients and their healthcare providers from using or switching to a biosimilar,” Cavazzoni says, “so it is important to know the facts. Unbiased information can help patients and their providers understand the treatment options available.”

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