Drugs

FDA Seeks Injunction Against LGM Pharma

FDA has asked a Florida federal court to issue a permanent injunction against LGM Pharma, headquartered in Boca Raton, FL, and two of its executives. The agency’s 1/11 complaint says LGM imports and distributes drugs, including active pharmaceutical ingredients, from a facility in Erlanger, KY.

FDA inspected the headquarters and Kentucky facilities in 3/2022 and 4/2022, the complaint says, and found multiple instances in which the defendants failed to adhere to current good manufacturing practice regulations for receiving, holding, and distributing drugs. The agency says many of the violations seen in the 2022 inspection were similar to inspection observations in a 2018 inspection.

The complaint lists the inspection observations and says the defendants cause the adulteration of drugs while held for sale and distribute adulterated drugs in interstate commerce.

“Defendants have a history of noncompliance with the Federal Food, Drug, and Cosmetic Act, have failed to adequately remedy violations, and continue to violate the act,” the complaint states.

FDA seeks an injunction to enjoin LGM and the executives from

introducing or delivering for introduction into interstate commerce drugs that are adulterated; and
violating the law by causing drugs to become adulterated while they are held for sale after shipment of one or more of their components in interstate commerce.

FDA also asks that the defendants be required to undertake actions to ensure that their methods and controls for receiving, labeling, holding, and/or distributing drugs, including quality controls, are established and operate in a manner that conforms with the act and its regulations and in a manner that FDA finds acceptable.

Finally, the court is asked to order that FDA be authorized to inspect the defendants’ places of business and all records relating to the receiving, holding, and distributing of any drug product to ensure continuing compliance with the injunction’s terms, with the defendants paying the costs of the inspections.

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

Read more

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