Drugs

Finalize Fecal Transplantation Guidance: Petition

The Microbiome Therapeutics Innovation Group is asking FDA to finalize a 2016 draft guidance that updated a 2013 guidance outlining an enforcement discretion policy on the IND requirements for using fecal microbiota transplantation (FMT) to treat C. difficile infection not responding to standard therapies while the agency further considered the matter. The group’s 7/2 petition says the 2016 update narrowed the enforcement discretion policy to exclude FMT products that are obtained from a stool bank and to ensure that the stool donor and stool are qualified by screening and testing under a doctor’s supervision.

“By not finalizing the 2016 draft guidance,” the petition says, “FDA has allowed commercial-scale stool banks to continue to screen donors, process samples, and commercially distribute FMT treatment products without complying with IND requirements, and without establishing the safety and efficacy of their drug products through prospective clinical trials. FDA’s failure to actively regulate the manufacture and widespread distribution of FMT products puts the public at risk of serious or life-threatening infections, as evidenced by its issuance of safety alerts in 2019, and which is now amplified because of the novel coronavirus pandemic.”

The petition asks the agency to:

finalize the 2016 draft guidance and specify that sponsors and manufacturers of commercial-scale FMT products are required to operate under an IND and therefore must implement and follow the same rigorous clinical regulatory manufacturing and quality controls applicable to other microbiota drug products that are being developed for licensure under FDA oversight;
retain the safe harbor for using FMT when the stool donor and stool are qualified by screening and testing under the direction of a healthcare provider to provide an FMT product to treat his or her patient;
provide additional guidance concerning the comprehensive approach FDA is considering for the study and use of FMT products under an IND; and
reiterate that the FMT enforcement discretion policy is an interim policy subject to change or revocation following further evaluation of its effects on patient safety and efficacy.

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