Following a series of issues and problems on which we have long been writing, K-V Pharmaceutical Company has said that the U.S. Food and Drug Administration (FDA) accepted its work plan to address the issues, according to Reuters.
In March, we wrote that the 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 <"https://www.yourlawyer.com/topics/overview/Ethex">generic drug recall. Like other ETHEX recalls from the previous several months, the expanded recall was necessary because of manufacturing problems and involved a variety of medications, all of which had been issued at the wholesale level and 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.
Reuters just noted that the pharmaceutical maker began taking steps indicated in the work plan, but does not intend to ship products until after third quarter of fiscal year 2010, citing a filing yesterday with the U.S. Securities and Exchange Commission (SEC). Regarding the cGMP issues, K-V Pharmaceuticals said it will likely have Lachman Consultants, K-V’s independent cGMP expert, handle the certification review this year. Should that certification find K-V Pharma in cGMP requirements, then the FDA will conduct a re-inspection of the facilities, reported Reuters.
Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of the facilities and certify compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the Decree. The Decree also required the defendants to destroy all drugs recalled between May 2008 and February 3, 2009.
Meanwhile, KV Pharmaceuticals suspended manufacturing and shipping of all of its products, including those made under the ETHEX name. That announcement followed an inspection that began in December by the FDA of the company’s operations and inventory. Because of the manufacturing problems cited by the agency, ETHEX issued several recalls last year. 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, 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 that the company had significant cGMP violations, yet continued to manufacture unapproved drugs.
