FDA Policy/General

House Committee Seeks FDA Answers on Cell Products

House Energy and Commerce Committee leaders are asking FDA to explain its slower than expected progress with manufacturers and providers of stem cell products to come into compliance with FDA’s guidance and premarket approval requirements, including those established by the 21^st Century Cures Act. The 7/25 letter to FDA acting commissioner Ned Sharpless noted the agency’s efforts to release a guidance in 2017 that further clarifies when cell and tissue-based products would be subject to FDA regulation and provided a 36-month period of enforcement discretion. “Despite these actions, manufacturers and providers have been slow to come into compliance ahead of the 11/2020 deadline, while reports of adverse events and misleading advertising and marketing to patients continue to rise,” lawmakers said.

“We want to register our concerns about the proliferation of unproven stem cell therapies on the market and our desires to ensure that the agency is doing everything in its power to protect patients,” the letter continued. “We would like to better understand the FDA’s current strategy for monitoring the market and bringing these therapies into compliance.”

The Committee leaders are requesting answers to a series of questions by 8/15, including:

How is the agency’s current work on regenerative medicine therapies, including stem cells, resourced?
Is FDA considering other strategies to encourage developers to engage with the agency early on?
How many agency officials are working to monitor adverse event reporting and respond to safety signals related to stem cell therapies? Would additional resources help the agency to conduct a more rigorous survey of the market?
Is FDA prepared for 11/2020, and the planned end to FDA’s policy of enforcement discretion, how will it communicate the transition to enforcement to non-compliant stem cell clinics?
How is FDA coordinating with other state and federal agencies?

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