Drugs

FDA Action Asked Against Pharmaceutical Associates Drugs

A citizen petition filed by Hyman, Phelps & McNamara on behalf of an unnamed client asks FDA for immediate enforcement action against unapproved potassium chloride oral solution drug products being marketed by Pharmaceutical Associates. The petition says 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.

The document reminds the agency that its compliance guide says that higher enforcement priority will be given to drugs that present direct challenges to the new drug approval and OTC monograph systems. The guide also says that all unapproved drugs introduced into the market after 9/19/11 are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities. The Pharmaceutical Associates drugs fall into both categories, the petition says.

“Unless FDA takes immediate enforcement action against Pharmaceutical Associates,” the petition says, “[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.”

The law firm also asserts that the unapproved drug products raise safety concerns as well as legal concerns. It notes that the labeling on the Pharmaceutical Associates products shows that they contain 5% alcohol as an excipient, which “significantly exceeds the level of alcohol FDA permits in drug products labeled for pediatric use. Moreover, end-users, such as hospitals, may unknowingly be exposed to liability as a result of administering a drug product to patients that is not approved by FDA for safety and effectiveness.”

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