Drugs

Regulate Outsourcing Ophthalmic Bevacizumab Products: Petition

Acting on behalf of an “interested client,” a Buchanan petition asks FDA to take immediate administrative and enforcement action against 503B outsourcing facilities distributing adulterated and misbranded ophthalmic Bevacizumab products. The petition asks FDA specifically to:

issue an order and/or formal guidance clarifying that compounded ophthalmic bevacizumab products do not meet the “clinical need” standard under the Federal Food, Drug, and Cosmetic Act and lack substantial evidence of safety and efficacy for intravitreal administration;
require all 503B outsourcing facilities that compound, repackage, or otherwise manufacture bevacizumab products for ophthalmic use to cease distribution until they have conducted and submitted to FDA comprehensive, long-term ocular toxicity studies for their specific final formulations;
require all 503B outsourcing facilities that compound, repackage, or otherwise manufacture bevacizumab products for ophthalmic use to cease distribution until they have submitted to FDA a complete chemistry, manufacturing, and controls data package for their final compounded product in the finished container-closure system;
conduct immediate for-cause current good manufacturing practice audits of both the substance manufacturers that supply bevacizumab bulk biologic to 503B outsourcing facilities and the 503B outsourcing facilities themselves;
declared compounded pre-filled bevacizumab syringes to be drug-device combination products and require 503B outsourcing facilities to cease distribution until they have demonstrated compliance with all applicable device regulations; and
take immediate enforcement action against Fagron Sterile Services and Leiters Health because the compounded ophthalmic bevacizumab products produced by these entities are adulterated and misbranded.

“The evidence presented in this petition is not speculative,” the document says. “It is based on scientific literature, market-wide recalls, historic and recent FDA inspectional observations and Warning Letters, and the agency’s own regulatory actions involving a submitted but yet-to-be-approved BLA…. Permitting the use of unapproved, repackaged bevacizumab injections could expose patients to unforeseen risks and result in medical negligence.”

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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