Biologics

10 Groups Oppose REGROW Bill

A coalition of 10 patient advocacy and research groups, including the Cystic Fibrosis, Muscular Dystrophy and National Patient Advocate foundations, the National MS Society, and the National Organization for Rare Disorders, say they oppose provisions in the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW Act). In a recent letter to the bill’s sponsor, Sen Mark Kirk (R-IL), the groups say that while they applaud his recognition of the cell and gene therapy and regenerative medicine sector’s therapeutic promise for patients with unmet medical needs, they are concerned that the legislation as drafted could compromise patient safety.

The letter says problems could arise because the bill would allow “conditional approval” for products that only show “preliminary clinical evidence of safety” in Phase 1 or 2 trials. “We are troubled,” the groups say, “that these provisions establish a new approval standard that is potentially lower than existing standards. By allowing products to be marketed as approved therapies, this implies to patients a high level of approval which is not warranted given the current requirements in the bill. We believe this legislation may result in grave consequences for patients.”

The groups say they also are concerned that the bill contains provisions that would make it difficult for FDA to withdraw such products from the market if it found safety problems.

“There exist several pathways to get critical treatments to patients quickly while maintaining strong FDA safety and efficacy standards,” the groups conclude. “These programs are aimed at unmet needs for serious life-threatening diseases that currently have no adequate approved treatment options. Consequently, we cannot support the REGROW Act in its current form.”

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