KV Pleads Guilty, Agrees to Close ETHEX Generic Drug PlantFeb 26, 2010 | Parker Waichman LLP
We have long been writing about a series of problems with K-V Pharmaceutical Company. In December, K-V Pharmaceutical said that the U.S. Food and Drug Administration (FDA) accepted its work plan to address the issues. Now, KV Pharmaceutical said it will be closing down its ETHEX generic drug unit, wrote The Associated Press (AP). The drug maker will also plead guilty to criminal charges that allege ETHEX neglected to appropriately advise regulators about significant manufacturing problems that posed dangers to consumers, wrote the AP.
Last March, we wrote that the U.S. Food and Drug Administration (FDA) announced that a Consent Decree of permanent injunction was filed enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers, from making and distributing adulterated and unapproved drugs. That move followed an extensive series of incidents regarding KV Pharmaceuticals and its subsidiaries.
Prior to that, ETHEX expanded an earlier generic drug recall. Like other ETHEX recalls from the prior several months, the expanded recall was necessary because of an array of manufacturing problems and involved a variety of medications, all of which had been issued at the wholesale level and which were expanded to the retail level. The recall was implemented because the products might have been manufactured under conditions that did not sufficiently comply with the FDA’s current Good Manufacturing Practice (cGMP) regulations.
Because of the manufacturing problems cited by the agency, ETHEX issued several recalls in 2008. In January, ETHEX issued a recall of its prescription infant vitamins and prescription iron supplements; also, problems at KV Pharmaceuticals prompted ETHEX to recall scores of generic drugs that might have been defective.
In December 2009, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. In June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.
The FDA inspected KV between December 2008 and February 2009, and found it to have significant cGMP violations while continuing to manufacture unapproved drugs.
Now, KV is planning on shutting down ETHEX Corporation because, following the plea, it will likely be excluded from government programs and will be paying about $27.6 million to resolve the government probe, said the AP, which added that charges relate to the firm’s failure “to file field alerts, or urgent notices about potential safety threats,” with the agency, specifically with dextroamphetamine, an ingredient Adderall, and propafenone, a cardiac medication. Adderall is prescribed in the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). The payment includes fines and restitution totaling $25.8 million and $2.3 to the federal government; ETHEX is not expected to contest an administrative forfeiture of $1.8 million, added the AP, citing KV.
CEO Marc Hermelin recently stepped down after a nearly 30-year career with the drug maker, the AP noted.