KV Pharmaceuticals – Long Time Problems with Issues - Quality Control, The FDA, and The Family – Will The One Time Top Drug Maker Survive?

This is an interesting history on how this company, originally all family owned, has struggled through many problems and issues and they still are not at bay. The most serious offences were those found by the FDA, with morphine sulfate tablets, an opiate, having twice the amount of the active ingredient, in other words everyone got a double dose and this was reported from pharmacists in California and Canada.

In addition several employees or former employees speak up about their roles in somewhat being coerced to do some “cover up” with reporting to the FDA and one former employee said their factory was just flat out dirty and standards were not up to par. He said even the machines were not clean that manufacture the products. The company has many generic drugs they make as well, but for now everything has been put on hold – no manufacturing.

They have entered into some marketing agreements with other companies and some are manufacturing limited amounts of their drugs, but this can’t go on forever. If you read the entire article, will consumers trust their products again, or will they know where some of their generic drugs are coming from.

The company’s big claim to fame and what brought them into being many years ago in the 40s was a chemical engineer who patented “timed released” medications. We all know what that is about, and on another side of the coin it sometimes allows for drug patents to be extended as the new drug is now formulated to be “time released” so the patent carries on a few more years without the prospect of a generic drug coming on to the market, or the generic version cannot be “timed released” and there could be other differentiations as well in order to market the new “named brand” product.

Selling drugs without FDA approval as the court cases state here as well is also right there with big problems as well, so without any manufacturing going on, how long will or can they last with being down to a quarter of their work force too? BD

By 2008, KV was considered one of the most successful publicly traded companies based in the St. Louis area, posting nearly $600 million in revenue and employing 1,700 people.
Today, it's a broken company with a criminal record.

Short on cash with no meaningful revenue stream, the company has shed three quarters of its work force, including 289 layoffs last week. The drugmaker is still waiting for permission from the U.S. Food and Drug Administration to resume manufacturing — and the pressure is rising.

Last month, a wholly owned subsidiary of KV Pharmaceutical — Ethex Corp. — pleaded guilty to two felony counts of criminal fraud for failing to report to the FDA that it was making oversize tablets that could be harmful to patients.

Essentially, investigators said, KV and its subsidiaries manufactured and sold dozens of different medicines without federal approval and tried to conceal its problems from federal regulators, according to court records.
As part of the plea agreement, the company was sentenced to five years of probation and ordered to pay $27.6 million in fines and restitution. No individuals have been charged in the ongoing criminal probe.

KV was founded in 1942 by Victor Hermelin and Bob Keith, both of St. Louis. Hermelin, who died last year, was a chemical engineer who went on to hold about 100 patents, including one that allows pharmaceuticals to be produced in the now familiar time-release form. He was succeeded in 1975 by his son, Marc.

KV's most recent quality control problems were discovered in May 2008, when pharmacists in California and Canada reported grossly oversize morphine sulfate tablets that were produced by a KV subsidiary. Morphine, an opiate, is prescribed as a painkiller. The errant tablets were double doses.

In the months leading up to KV's recalls, former employees say supervisors encouraged them to skirt FDA protocol to meet the company's production demands.
Dwayne Spears, a former production worker who helped audit the company's Particle Dynamics division, said he was expected to alter chemical test results — including the size of particles exceeding guidelines — to meet FDA standards.

The company faces at least 30 pending lawsuits from patients and their families who have accused KV Pharmaceutical of making and selling medicines that caused bodily injury and/or economic harm, including 15 wrongful death suits.

The company also has struck a deal with Purdue Pharma LP. Under the court settlement, Purdue will manufacture Oxycontin ER (Extended Release) tablets, and KV will sell those painkillers.