Devices

Judge Refuses to Ban Sales of Repro-Med Devices

Since it is well established that FDA Warning Letters do not represent final agency action, in his five-page order, Nunley, an Obama appointee, declined to address these allegations and instead focused on EMED’s claims of irreparable harm if RMS sales in California were not stopped. He found the company had “failed to demonstrate it will be irreparably harmed if an injunction does not issue or the balance of hardships tips in its favor.”

In its argument for the injunction, Nunley wrote, EMED alleged that RMS had committed “unlawful or unfair business acts in violation of California’s Unfair Competition Law (‘UCL’).” “EMED argues RMS made unlawful and unfair statements about its products which resulted in harm to EMED. … RMS argues that EMED cannot demonstrate a likelihood of success on the merits because (1) the Food, Drug and Cosmetic Act (‘FDCA’) preempts EMED’s claims, (2) EMED’s claims fall within the jurisdiction of the FDA, (3) The FDA Warning Letter is not evidence that the FDA made a determination about RMS’s products, (4) RMS’s statements are not false or misleading, and (5) there is no basis for the injunctive relief EMED seeks.”

The dispute between the two companies, and RMS’s allegation of FDA favoritism toward EMED in its regulatory processes, were described here in April.

California Eastern District federal judge Troy L. Nunley 6/5 denied a motion for preliminary injunction seeking a statewide ban on sales of New York-based Repo-Med Systems (RMS) infusion pumps and needle sets because of alleged violations of FDA 510(k) clearance requirements. The injunction was sought by competitor EMED Technologies on claims that it would suffer irreparable harm if RMS’s marketing of the disputed products continued. EMED alleged that a 2/26/16 FDA Warning Letter documented “various violations” found during an inspection and said the RMS devices were misbranded and adulterated because they were being marketed for uses beyond their 510(k) clearances.

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