Drugs

FDA Consent Decree Against Franck Compounding Operations

A Florida federal judge has entered a consent decree against Paul W. Franck of Ocala, FL that prohibits his drug compounding operations from making sterile drug products until they comply with GMPs. According to the decree, Franck manufactured and distributed drug products that were adulterated and misbranded. “Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” CDER director Janet Woodcock is quoted in a release as saying.

Franck owned and operated several compounding pharmacies including Franck’s Lab Inc., doing business as Franck’s Compounding Lab and Trinity Care Solutions. The government contends drug products manufactured “contained filthy, putrid, or decomposed substances; were prepared, packed or held under insanitary conditions; and fell below the quality and/or purity standards they purported to possess. Franck’s drug products were also misbranded under the FD&C Act because their labeling was false or misleading since drugs purporting to be sterile contained bacterial contamination.”

Franck has a history of manufacturing problems. In 2014, FDA says Trinity Care Solutions recalled its sterile drugs and halted operations after an agency inspection found several violations, including the presence of dead spiders, beetles, ants, wasps and cockroaches in the ceiling panel directly above the area where employees prepare for sterile processing and failure to adequately clean and sanitize sterile compounding areas. “In 2012, contaminated ophthalmic drugs compounded by Franck’s Compounding Lab were linked to at least 47 cases of eye infections, including at least 39 cases of temporary or permanent vision loss. The company subsequently recalled all sterile products and ceased operations,” it says. The company also received a Warning Letter from the agency.

Additionally, in 2009, 21 polo ponies died after receiving a drug product compounded by Franck’s Compounding Lab that contained 100 times the amount of selenium that should have been administered.

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