Drugs

FDA Denies Petition for Action on Unapproved Potassium Chloride

FDA has denied a Haner & Kuo (New York) citizen petition, which was filed on behalf of an unnamed client, that asked FDA for immediate enforcement action against unapproved potassium chloride oral solution drug products being marketed by Pharmaceutical Associates. Like several others still pending at the agency, this petition said the drugs are being marketed in violation of the Federal Food, Drug, and Cosmetic Act and of the FDA 9/2011 compliance guide dealing with marketing new drugs without approved NDAs or ANDAs.

“Unless FDA takes immediate enforcement action against Pharmaceutical Associates,” the petition said, “[that company] will continue to take market share from companies that lawfully market potassium chloride oral solution drug products. Moreover, other drug manufacturers, noticing an absence of FDA enforcement action, may take a page out of Pharmaceutical Associates’ playbook and begin marketing their own unapproved potassium chloride oral solution drug products. FDA needs to step in now to put an end to this illegal practice and to send a clear message … that such illegal activities will not be tolerated.”

In its denial letter, CDER director Janet Woodcock said requests for the agency to take enforcement actions “are not within the scope of its citizen petition procedures.” She said petitions may not be used for “the referral of a matter to a United States attorney for the initiation of court enforcement action and related correspondence... Agency decisions to take enforcement actions are decisions related to (and involve correspondence relevant to) the referral of a matter to a U.S. Attorney for the initiation of a court enforcement action for violations of the Federal Food, Drug and Cosmetic Act.”

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