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A drug which sells for 10-15 dollars K-V Pharmaceuticals wants to sell it for $1,500, and
it wants the cheap version, which has been on the market for years to be removed with the help of the FDA. Corporate drug business as usual. FDA wouldn’t remove the cheap version because of complaint by insurers. K-V says it will go bankrupt without FDA intervention Agency's lack of action on Makena, compounds K-V's financial
troubles July 6, 2012 | By Eric
Palmer |
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K-V says it will go bankrupt without FDA intervention Agency's lack of action on Makena, compounds K-V's financial troubles July 6, 2012 | By Eric
Palmer 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 Related Articles: |
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