Price Of Premature-Birth Drug Criticized Last week, we reported on a new progesterone gel that has been shown to reduce premature birth in some high risk pregnancies. An injectable version of the same hormone has now been thrust into the spotlight as well, as lawmakers, pharmacies and a drug company fight over how much it should — or shouldn't — cost.
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Price Of Premature-Birth Drug Criticized

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Price Of Premature-Birth Drug Criticized

Price Of Premature-Birth Drug Criticized

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Let's turn, now, to a story about mothers who try to bring their babies to term. Last week, we told you about a new progesterone gel that has been shown to reduce premature birth in some high-risk pregnancies. An injectable version of that same hormone is now in the spotlight because lawmakers, pharmacies and a drug company are fighting over how much it should cost. Reporter Gretchen Cuda-Kroen has the story.

GRETCHEN CUDA-KROEN: The injectable form of progesterone, otherwise known as 17P, has been used to prevent premature birth since the 1950s. The company that used to make it stopped selling it in 2000 and since then, the only makers have been compounding pharmacies - specialty pharmacies with the capability to produce individual, made-to-order compounds. But in early February, all that changed when a small drug company won FDA approval to manufacture the drug - and gave the medical establishment a serious case of sticker shock.

Jay Iams, an Ohio State Medical Center obstetrician specializing in high-risk pregnancies, explains.

Dr. JAY IAMS (Maternal Fetal Medicine Specialist, Ohio State University Medical Center): It's been available to us for eight years now as a locally made, compounded product, for about $30 a month. And when it made it through the FDA process, the company that put it on the market announced an initial price of $1,500 per dose - or $6,000 a month.

CUDA-KROEN: At that price, a typical, 20-week course of the treatment of Makena - the name of the new drug - would cost $30,000, compared to a few hundred dollars for the generic version produced by pharmacies. The company, K-V Pharmaceuticals, had exclusive rights to make it for the next seven years, and it wasted no time in warning pharmacies they would risk FDA enforcement if they continued to sell the generic drug.

Robert DuPont of SBH Pharmaceuticals, a compounding pharmacy in Columbus, Ohio, says this put compounding pharmacies in a bind.

Dr. ROBERT DUPONT (SBH Pharmaceuticals): We did have situations where we had to go ahead and provide medications just because we had some individuals that were currently on the product, and we weren't going to let them suffer.

CUDA-KROEN: But as it turned out, K-V spoke too soon about FDA enforcement policies. Numerous complaints prompted a number of professional medical societies to oppose the drug's price.

Senator Sherrod Brown, of Ohio, took up the cause with the FDA, Medicaid and Medicare, and the Federal Trade Commission as well. In response, the FDA said it would not attempt to prosecute compounding pharmacies who continued to supply the drug to their patients unless there were safety concerns. K-V followed shortly by dropping its price by roughly half, bringing the total cost of treatment from $30,000 to $15,000. But Senator Brown says that's not nearly enough.

Senator SHERROD BROWN (Democrat, Ohio): Their argument that, well, a low-birth-weight baby costs on the average $51,000 in the first year, and their treatment only costs $15,000, just doesn't hold any water with me because this treatment was no more than $200 or $300 or $400 for the whole treatment - and it changed lives. And there's just no excuse for their pricing this the way they did.

CUDA-KROEN: K-V doesn't agree. The company told NPR via email that it has already committed a quarter of a billion dollars into the research and development of Makena. It says the investment in meeting the high standards of an FDA-approved drug will result in better quality control, and improved consumer safety. Furthermore, the company says it will offer government rebates and financial assistance to eligible women.

Even so, George Saade, president of the Society for Maternal Fetal Medicine, estimates taxpayers will still shoulder an additional $2 billion in increased costs - a figure he says is actually greater than the money saved by the premature births it would prevent. And while a commercial drug may offer some logistical advantages, Saade argues there's no medical advantage over the currently available therapy.

Dr. GEORGE SAADE (President, Society for Maternal-Fetal Medicine): If you compare it to nothing, yes, then you're preventing all these pre-term births when you use it. But you have to compare it to what we have now. And there is very little additional saving, if any.

CUDA-KROEN: Drug manufactures are certainly entitled to recoup their investments, and even make a profit, Senator Brown says. If sales were similar to the pharmacy compound, he says the company stands to make billions of dollars in a single year off Makena more than enough to recoup costs.

Although that's no longer such a sure thing. Unless prices come down significantly, George Saade says he and his colleagues will be sending their patients to the same place they always have - the compounding pharmacy.

For NPR News, I'm Gretchen Cuda-Kroen, in Cleveland.

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