FDA Announced Injunction Against KV Pharmaceutical
Yesterday, March 2, 2009, the FDA and KV Pharmaceutical both announced that a Consent Decree of permanent injunction had been entered between them. KV Pharm has agreed to cease making and distributing what the FDA calls “adulterated and unapproved drugs.” This includes KV Pharm’s subsidiaries ETHEX Corporation and Ther-Rx Corporation.
The injunction will prevent KV Pharm from manufacturing and shipping drugs until the firm obtains FDA approval. KV has also agreed that it will not distribute certain products, including its prenatal vitamins and hematinic products, until the products have met the FDA’s approval guidelines.
It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for five years.
KV Pharm will not be allowed to resume manufacturing until an independent third party and the FDA both certify compliance with the FDA’s regulations. The Consent Decree also requires the defendants to destroy all drugs they recalled between May 2008 and Feb. 3, 2009.
“The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs."
The Consent Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and the payment of an additional $15,000 for each violation, up to $5 million per year.