K-V Pharma loses FDA lawsuit over Makena

Hannah Blake

pharmaphorum

A Washington judge has dismissed K-V Pharmaceuticals’ lawsuit against the US Food and Drug Association (FDA). K-V Pharma was seeking for continued protection from its competitors by having sales by pharmacies of cheap, unapproved versions of its premature birth drug, Makena, banned. K-V Pharma claimed in its lawsuit that the FDA had decided to not to crack down on the pharmacies out of concern for insurance companies' costs, rather than patients' needs.

"The central issue for K-V Pharmaceutical ... has always been to ensure that pregnant women have access to Makena, the only drug approved by the FDA for their condition,"

Comment from K-V Pharmaceuticals spokesman Tony Herrling.

Makena is an injectable hormonal drug that reduces the risk of pre-term birth in women who have delivered early in the past. District Judge Amy Berman Jackson, in Washington D.C., made the decision to dismiss K-V Pharma’s lawsuit a month after K-V Pharma filed for Chapter 11 bankruptcyin July. It is alleged that K-V Pharma is “almost entirely reliant” on the success of Makena, as it needs the money to make debt payments.

"This case is fundamentally an effort to get the court to direct and oversee the FDA's enforcement activities, and that it cannot do."

An extract from the 38-page ruling by District Judge Amy Berman Jackson.

There have been many discussions surrounding K-V Pharma’s Makena, ever since the FDA approved Makena last year under the Orphan Drug Act. This is because shortly afterwards, K-V set the pricing of the drug at US $1,500, compared with US $10-$20 a week for compound versions. One woman was so angry she started a Facebook page to complain – take a look at Daniel Ghinn’s discussion about this in his recent article.