Biologics

Petition Urges FDA to Ease Oversight of Stem Cell Products

A biotechnology company specializing in adult-derived stem cells is urging FDA to loosen federal regulation of some regenerative therapies, arguing that products meeting strict manufacturing and facility standards should be governed under the agency’s lower-risk framework for human cell and tissue products. A just-filed citizen petition submitted by Orrick, Herrington & Sutcliffe on behalf of the unnamed biotech asked the agency to amend its regulations so that certain adult stem cell products used in orthopedics, wound care, and pain management would be regulated solely under section 361 of the Public Health Service Act — the same pathway that covers many tissue-based products — rather than as biological drugs requiring premarket approval under section 351.

The petitioner contends that if stem cell products are produced in FDA-registered facilities that follow current good manufacturing practices and are accredited by recognized organizations such as the American Association of Tissue Banks or National Marrow Donor Program, they should qualify as so-called “361 HCT/Ps.” Under that classification, products must meet standards to prevent disease transmission but are exempt from the costly and time-consuming biologics license process.

The filing argues that the change would expand patient access to stem cell therapies while preserving essential safety safeguards, aligning with federal initiatives such as the 21st Century Cures Act, which encourages faster access to innovative regenerative treatments. The petition also points to Florida’s 2023 stem cell statute as a model that already ties access to state-regulated facilities operating under FDA’s cGMP requirements.

According to the petition, FDA could either amend § 1271.10(a) directly or add a new exemption under § 1271.15 or a definitional clarification under § 1271.3 to achieve the same result. Pending any rulemaking, the petitioner also asks FDA to exercise enforcement discretion for compliant stem cell products meeting the proposed criteria.

The petition concludes that a federal rule aligned with state frameworks would “increase regulatory certainty, encourage adherence to rigorous manufacturing standards, reduce unnecessary premarket burdens, and maintain robust public health protections.”

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