Drugs

Radiopharmaceutical Companies Want FDA Consistency

With radiopharmaceutical therapies projected to expand greatly, some manufacturers are raising issues about inconsistent FDA actions through the Radiopharmaceutical Manufacturers and Therapeutic Alliance (RMTA), a trade group that evolved this year from the Medical Imaging Technology Alliance’s PET Working Group. An online AuntMinnie.com post says uneven FDA inspections are one of the alliance’s concerns that were discussed by the group’s regulatory affairs and government relations insiders who met with AuntMinnie to discuss their concerns.

RMTA regulatory committee chair Ashley Mishoe reported that some facilities are told everything is fine at inspections because they’re following existing regulations, while some are told they must change, and the expectations for them are very different.

“The industry is experiencing inconsistent FDA inspection expectations, including apparent policy shifts,” Mishoe said. “Policies are being implemented inspection-by-inspection rather than through guidance or rulemaking, which is causing a lot of uncertainty and ultimately risking patient access. This causes regulatory and operational inequities.”

RMTA and the Coalition of PET Drug Manufacturers reportedly have clarified their issues in letters to FDA. They are said to have made several requests, including creating a permanent role for a PET drug subject matter expert at FDA, strengthening training around PET good manufacturing practices, and implementing changes in a controlled fashion in accordance with established rulemaking procedures.

“These inconsistencies have at times created immense confusion for network-based PET drug manufacturers, who may receive conflicting feedback about the same processes at different site inspections,” the RMTA letter said. “The net effect is a tremendous expenditure of industry resources on attempting to come in line with shifting practices that have not been formally announced, with little to no apparent positive return on product safety.”

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