KV Pharmaceutical Company has entered into a consent decree with the US Food and Drug Administration (FDA) regarding the company's drug manufacturing and distribution. The decree provides a series of measures that, when satisfied, will permit KV to resume the manufacture and distribution of products marketed by its subsidiaries, Ethex and Ther-Rx. The company is working expeditiously to satisfy the requirements and expects to provide further information in upcoming communications.
As part of the consent decree, KV has agreed not to market products it manufactures until it has satisfied certain requirements designed to demonstrate compliance with FDA's current good manufacturing practices (CGMP) regulations. KV has also agreed that it will not distribute certain products, including its prenatal vitamins and haematinic products, until the products are approved by FDA's ANDA or NDA processes.
"We have been working diligently with the FDA for the last two months to reach agreement on a clear path forward to permit KV to resume manufacturing and marketing its products," said David A Van Vliet, KV's Interim chief executive officer. "Since December, when new management took over at KV, our team has taken significant steps to enhance our systems and procedures, and we will continue to do so. We look forward to cooperating with the FDA during this process that will facilitate our return to the market. Predicting the timing for the return and the ultimate product assortment that we will market are presently very difficult due to the range of variables that must be managed. As we gain certainty, we will notify customers and all other stakeholders."
The consent decree provides that, before resuming manufacturing, KV will have an independent third party CGMP expert consultant undertake a review of KV's facilities and certify compliance with FDA's CGMP regulations. Following that certification, FDA will make a determination as to whether the KV facilities are in compliance. The decree further provides that KV may request of FDA that it be permitted to resume manufacturing and distribution of certain products before the company is cleared by FDA to resume full operations. KV has already retained the third party CGMP expert consultant, which has been on-site for several weeks.
The consent decree is expected to be submitted today to the US District Court, Eastern District of Missouri, Eastern Division by the Department of Justice and is subject to approval by the Court.
KV Pharma is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products.