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Drug maker lowers price of Makena pregnancy drug to $690 per dose

After being lambasted for boosting the price of of a dose of the pregnancy drug Makena from $20 to $1,500, K-V Pharamceutical lowers it to $690. The move comes two days after the FDA publicly invited competition to make the drug, commonly called 17P.

April 01, 2011|By Andrew Zajac, Washington Bureau

A K-V spokeswoman said via email that Hermelin no longer is affiliated with the company.

The company "continues to move forward as a compliant, quality-driven organization," K-V spokeswoman Jennifer Forst said in an email. "Our commercial operations are backed by a historical and proven marketing capability that we believe will return our Company to revenue sustainability, profitability and value to our shareholders."

Hermelin's case was one of several legal difficulties described in K-V's SEC filings.

In a case related to Hermelin's, a K-V subsidiary pleaded guilty to felony charges of failing to report flawed tablets to the FDA and agreed to pay fines, restitution and forfeitures totaling $27.6 million, according to filings.

And since March 2009, K-V has operated under a consent decree that puts its drug manufacturing under close FDA supervision. Legal and regulatory problems "have had, and are expected to continue to have a material adverse effect on our operations," the company's 2010 annual report states.

If K-V cannot resume selling existing products, "or if our planned [Makena] product is not approved by the FDA on a timely basis, or if revenues from its sale prove to be insufficient, our financial position ? will continue to be materially adversely affected," says the report, which was filed in December 2010, more than a month before Makena was approved.

The compounding pharmacies that make Makena's competitor, 17P, are licensed and regulated by the states.

Drugs made by compounding pharmacies are not FDA-approved – essentially because each prescription is tailor-made and drugs approved by the FDA undergo clinical trials and other lengthy testing that would be impossible to conduct for individual preparations.

But FDA does have broad discretion and can clamp down on compounders if it feels they're competing unfairly with pharmaceutical companies. It was that discretionary authority that K-V referred to in its warning letters to pharmacists.

K-V's price reduction did not impress compounding pharmacist Chuck Leiter of Leiter's Pharmacy in San Jose.

"They're still way out of line," said Leiter.

Leiter said he charges the equivalent of $6.50 per dose to make the drug "and my costs are a lot higher than theirs…. It's an easy thing to make." His price may be lower than other compounders because he also supplies hospitals and makes relatively large quantities, he said.

Leiter said he recently sold an area hospital a several-month supply of the drug in case compounders were forced to stop making it.

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