K-V says it will go bankrupt without FDA intervention

K-V Pharmaceutical ($KV.A) claims in a lawsuit that if the FDA does not allow it to exclusively make the premature birth drug Makena and charge 35 times more per injection than compounders, its business is kaput.

In a lawsuit filed Thursday against the FDA, K-V says without the protection it will be bankrupt in three to 6 months, reports Reuters.

Makena is a hormone that is injected to lower the risk of premature birth in women who have had babies prematurely in the past. The company and the agency have been circling each other for months over the drug, which women have traditionally gotten for $10 to $20 per injection in compounded form, compared with the $1,500 K-V initially wanted to charge when the FDA approved its version in February 2011. It dropped the price to $695, a 55% cut, after charges that it was price gouging.

The agency has publicly declared that the approved version is preferable, but left the compounds on the market. When K-V complained that they may not provide safe, effective and consistent treatment, the FDA tested a bunch of them and decided that in fact they did. Insurers have naturally sided with compounders and the FDA on the matter.

The K-V legal complaint contends FDA does not have the authority to rule on drugs based on price, only on science, and that the science shows an FDA approved drug is better than one that is unapproved. The agency declined to comment about the lawsuit.

K-V claims of being on the ropes is not just legal hyperbole. The company has been in trouble for years after the feds discovered it had covered up manufacturing problems and fined it $25.8 million. Its former CEO was sent to jail and the company is facing a $1.5 billion lawsuit claiming it hid problems from shareholders as well. Unable to make the drugs it previously manufactured, it sees Makena as its last hope against a premature demise.

- here is the Reuters story