The Big ‘Disaster’ At KV Pharmaceuticals
5 CommentsBy Ed Silverman // April 6th, 2010 // 7:08 am
File this under ‘if something can go wrong, it will.’ KV Pharmaceutical was tagged last year by the FDA for making and selling unadulterated and unapproved drugs (see here). Since then, manufacturing has been idle for 15 months, KV is short of cash, and 289 people - or about three-quarters of its workforce - was just let go.
Meanwhile, David Hermelin, a former vp of corporate strategy and operations, filed a charge of religious discrimination against KV last September. KV denies his dismissal was tied to religion. Hermelin is the son of Marc Hermelin, KV’s former chairman and ceo, who was dismissed in December 2008 amid a probe into alleged mismanagement, The St. Louis Business Journal writes. However, Marc Hermelin claims he retired from his position prior to his termination by the board. At stake in the dispute is $10.8 million in accrued retirement benefits. Both David Hermelin and Marc Hermelin are still members of KV’s board, because they hold 62 percent of the voting power of two classes of common stock.
And last month, a wholly owned subsidiary known as Ethex 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, The St. Louis Post-Dispatch notes. A KV exec considered what to do in July 2008 after KV discovered oversize tablets and oOne option was “to do nothing because the probability of oversized tablets is very low,” Assistant US Attorney Andrew Lay said in court papers. Over the objections of other employees, the executive chose the “do-nothing option.” The unnamed exec instructed multiple employees to “minimize written communications about KV’s oversized tablet manufacturing problems and limit distribution and discussion of any documents discussing these problems,” according to the prosecutor.
“Bottom line is you just don’t mess with the FDA, and this has happened again and again at KV,” Juli Niemann, an analyst at Smith, Moore & Co., tells the Post-Dispatch. “Trying to take shortcuts for profitability is a systemic problem there.” Adds Lawrence Solow, an analyst at CJS Securities: “It’s a disaster.”
“It’s a disaster,” said Lawrence Solow, an analyst at CJS Securities, a New York brokerage and research firm. “If within six months they don’t start generating revenues, they may end up in bankruptcy.”
harpy
methinks you perhaps mean “adulterated” in the first sentence
JaT
Oversized pills would have to contain more exipients. These are not just fillers. They help to determine the delivery of the active ingredient. A blunder could result in a very different effect from the drug. What a mess where labeling and warnings are concerned. FDA is right to put it’s collective foot down.
Josh
JaT the real concern would be active ingredients. Sure binders and fillers could have some effect on the delivery, but when patients are on digoxin….the effects of a tablet with higher than labeled dosage is fatal.
JaT
Agreed, Josh.
Hard to imagine how this could even happen. Someone grabs the wrong molds?
Josh
Actually pretty easy to imagine if you work on the manufacturing side. Malfunction in the press, someone has a set of punches and dies that don’t match up (one of the punches is wrong and the rest are correct, and thus don’t get caught during IPCs), missing IPCs totally, backup at a deduster pushes powder into the dies, etc. Old equipment could also be a culprit.