Biologics

Greater FDA Oversight of SCRI Products Needed, Pew Says

The Pew Charitable Trusts says FDA needs to maintain pressure on businesses offering unapproved stem cell and regenerative medicine interventions (SCRIs) and ensure that patients are protected from SCRIs that have caused harm or have the potential to cause harm. Pew says it gathered reports of adverse events linked to unapproved SCRIs administered outside of clinical trials. It identified reports of 360 people who had adverse events between 2004 and 9/2020.

“Pew’s findings reinforce the need for increased FDA enforcement action against businesses that manufacture and market these unapproved, and in many cases, unproven, products,” the report says. “They also underscore how more frequent and thorough reporting of adverse events by consumers and clinicians, and FDA’s use of social media data, could allow the agency to more quickly identify businesses that are putting patients’ health at risk and target its limited oversight resources more effectively. More broadly, the findings highlight the importance of FDA oversight in ensuring that regenerative products on the market are safe and effective.”

According to Pew, hundreds of businesses continued to operate under FDA’s policy of enforcement discretion that had been due to end 11/2020 and was extended to 5/2021 due to the Covid-19 pandemic.

“FDA announced in 4/2021 that it would not extend this period any further, which is an encouraging development,” the report says. “It should now move quickly to enforce its regulations and bring the industry into compliance. The agency also needs adequate resources to do so.”

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