Struggling K-V Pharma brings lawsuit against FDA

Short on alternatives to boost sales of its pre-term birth drug Makena and to stay afloat, K-V Pharmaceutical ($KV.A) has mounted a lawsuit against the FDA for failing to stop pharmacies from preparing their own versions of the drug, Reuters reported. Without help from the agency to prevent sales of the pharmacy preparations, K-V says that within three to 6 months the company would go bankrupt.

The case follows claims from lawmakers that St. Louis-based K-V was price-gouging insurers with the high cost of its drug, which had been available on the cheap from pharmacies for years prior to its approval last year. As Reuters reports, K-V has threatened to sue pharmacies for doling out their own versions of the drug and even sliced the $1,500 price of Makena roughly in half to gain a footing in the market. However, these tactics have obviously fallen short as the company now embarks on legal action against the FDA to stave off financial ruin.

K-V claims that its version of the drug is safer for patients and meets higher standards as an FDA-approved product. The pharmacy preparations lack the agency's stamp, of course, but regulators late last month reported that, despite some impurities found, their tests determined that the pharmacy versions were no threat to patients. K-V's lawsuit protests the agency's stance on the issue, saying that the regulator has put pricing concerns before its legal obligation to follow science.

The company's share price has sunk more than 80% over the past 12 months, putting the stock below the $1 amount it needs to keep in good standing with the New York Stock Exchange. The wounded stock price certainly doesn't help K-V's financial position, which puts the company just months away from going broke.

- read Reuters' article

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