U.S. Food and Drug Administration (FDA) and U.S. Marshals Service representatives just seized $24.2 million worth of unapproved drugs from KV Pharmaceutical Company of St. Louis, Missouri. The seizure followed a civil forteiture suit filing by United States Attorney Catherine L. Hanaway in which a a warrant was obtained to seize the unapproved new drug products being made by KV Pharmaceutical. “American consumers are entitled to have safe and effective drugs,” said Hanaway.
The products seized were made after the FDA required an end to production and the seizure followed an inspection of several of the company’s plants where FDA investigators found KV Pharmaceutical was not in compliance with a prior FDA enforcement notice. KV was also manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products. “The FDA is committed to taking enforcement action against firms that circumvent the drug approval process,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace.”
Earlier this year, a routine FDA inspection of KV Pharmaceutical’s facilities it was violating a May 29, 2007, notice (72 FR 29517) requiring companies to “stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.” Products in timed-release form require FDA approval to ensure active ingredients are released at the correct rate. Improperly manufactured timed-release products may release active ingredients too quickly, too slowly, or not at all, rendering the medication unsafe or ineffective. The FDA required companies to stop manufacturing such products before August 27, 2007, and to stop shipping such products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs.
Also, the inspection found KV Pharmaceutical to be manufacturing and distributing other unapproved drug products. “The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date,” said Deborah M. Autor, director of the FDA’s Office of Compliance within CDER. “When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company’s other unapproved drugs.” In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs—Compliance Policy Guide (CPG).” This CPG states that companies may not market drugs requiring approval without first establishing, through applications for approval, that such products are safe and effective.
Following is a list of those drug products seized and scheduled for destruction. The seized products are being held under embargo by the state of Missouri; however, if you are in possession of these drugs, please contact your healthcare provider for an FDA-approved alternative:
- PhenaVent: Capsules, LA Capsules, and PED Capsules
- Ethezyme Papain, Ethezyme 650 Papain, and Ethezyme 830 Papain: Urea Ointment
- Hista-Vent: DA Tablets
- Meperidine/Promethazine: Capsules
- Pseudovent: Capsules, 400 Capsules, and PED Capsules
- Tri-Vent: DM Syrup and DPC Syrup
- Hydro-Tussin: DM Liquid, CBX Syrup, DHC Syrup, EXP Syrup, and HD Syrup
- Hyoscyamine Sulfate: Sublingual Tablets
- Hydroquinone: 4% Cream and 4% Cream with Sunscreen
- Bromfenex: Extended Release Capsules and PD Extended Release Capsules