Drugs

Compounding ‘Clinical Need’ Petition Denied

FDA has denied a 9/30/20 petition submitted by the Outsourcing Facilities Association asking that the agency issue a regulation defining “clinical need” and establish a list of bulk drug substances for which there is a clinical need. The agency denial letter says the petition asked FDA to define “clinical need” to mean a healthcare practitioner’s intent or determination to prescribe or administer a compounded drug product containing the bulk drug substances in the healthcare setting for his or her patients.

FDA says the proposed definition is contrary to law and would undermine the law’s public health purpose. The letter says Congress required FDA to consider the drug products that outsourcing facilities propose to compound with the bulk drug substance and the need for such compounded products in light of available FDA-approved drugs.

“The agency’s review provides critical public health protections and helps ensure that outsourcing facilities do not operate as conventional manufacturers,” the letter says. “It protects patients by helping to ensure they are not unnecessarily exposed to compounded drugs that have not been subject to premarket review for safety or efficacy when an FDA-approved drug is available. It also protects the integrity of the drug approval process. The definition of clinical need proposed by the petition … would impermissibly narrow, and apparently even eliminate, this critical task that Congress charged the agency to perform.”

The denial letter also says FDA has interpreted clinical need through a “robust and transparent process.”

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