Preterm birth drug manufacturer sues states - KFDA - NewsChannel 10 / Amarillo News, Weather, Sports

Preterm birth drug manufacturer sues states

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Amarillo, TX -- One drug manufacturer is putting its profits ahead of public health, according to pharmacies around the nation.

Makena is the brand name of progesterone, a widely-used drug that lowers the chances of premature birth for pregnant women who may be at risk for it - and now the manufacturer is suing states to accept its $1500-a-dose price tag.

Last year, the Food and Drug Administration approved Makena, and that's when KV Pharmaceutical, the drug's marketer, set a price tag that some say is astronomical.

Compounding pharmacies make a generic version of the drug for less than twenty dollars a dose, but drugs that have FDA approval are generally more widely prescribed.

A statement on Makena's website said "... compounded drugs may present risks to patients because they have not been evaluated for safety and effectiveness by the FDA, or if they have been improperly compounded."

Pharmacists say KV is leveraging Makena's FDA backing to force an unfair price on patients and monopolize the market, as Robin Johnson of King's Compounding Pharmacy in Amarillo says,

"We can all come to our own conclusion: whether a $17.20 injection provided by somebody that you know and you trust; that would be compared to a $1500 injection by somebody else who used data that they obtained from us to say that their product is better than ours."

The day after KV announced the cost, the March of Dimes immediately ended their relationship, saying KV was putting its bottom line ahead of the two entities' stated goal of saving premature babies.

So far, KV has sued three states to offer and pay for Makena through Medicaid - Illinois, South Carolina, and Georgia.

KV has not yet filed suit in Texas, but says the state's Medicaid policy is unacceptable.

The $1500 number was based on the average hospital bill for the care of a premature baby - which is thirty thousand dollars.

And progesterone is generally given over about twenty doses, so it works out to thirty thousand.

If you'd like to see the FDA analysis of Makena or learn more about the controversy surrounding it, follow the links attached to this story.