Sherrod Brown: Drug firm fleecing pregnant women

This month, pregnant women using a popular drug to prevent premature labor could see the price per dose increase from $10 to $1,500. Almost overnight, a drug company created a monopoly for an existing product by exploiting drug safety laws — bilking taxpayers and threatening public health.

The risks from premature births are well known. A premature baby is more likely to develop health complications. Premature births cost an average of $51,000 in the first year, and they account for $26 billion annually in medical costs.

Starting in 2003, some pharmacists started compounding treatments to reduce the risk of preterm birth by 36% in high-risk women. A dose of this treatment, called progesterone, costs about $10 a week over the course of 20 weeks.

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Compounded drugs do not need Food and Drug Administration approval. So when the progesterone treatment went through clinical trials and received FDA approval, many public health advocates cheered. But what seemed like good news for mothers-to-be turned into a potential nightmare.

According to its own reports, KV Pharmaceutical paid $200 million to acquire exclusive rights to sell the progesterone treatment — which it will market as Makena — for seven years. With FDA approval in hand, KV sent a cease-and-desist letter to pharmacies to prevent them from selling the drug. Last week, KV announced it would sell Makena for $1,500 per dose — an estimated $30,000 per pregnancy.

The company justified this price hike by citing research-and-development costs, and KV even implied that the more expensive treatment is still below the costs of having a premature birth.

At $1,500 per dose, KV could recoup its $200 million investment 18 times in the first year — netting a $3.9 billion profit.

The development of progesterone treatments was funded by the National Institutes of Health. But instead of patients or taxpayers receiving the benefit, a private company will fleece pregnant women, reduce access to a life-saving treatment and drive up health costs.

Our laws give drug companies a temporary monopoly to recoup R&D costs as an incentive to develop new drugs. A longer period is granted for "orphan drugs" — an important inducement when small patient groups or rare diseases are involved. But when a company makes limited R&D investments, benefits from taxpayer-funded research, then grossly overprices a drug — risking an increase in premature births — something is very wrong.

What's the answer?

KV could do the right thing. Recapture its investment with a nice profit, sure. But don't create a public health disaster. If it does not, Congress could take steps to prevent abuse of the FDA approval process. It could shorten the monopoly period based on the amount of R&D for which a company is responsible. It could allow the federal government to negotiate drug prices as governments do in most other developed nations. But none of this should be necessary.

When a drug company declares war on American families, Congress must intervene. Earlier this month, I sent a letter asking KV to reconsider this massive price increase. Days later, KV hired a major Washington lobbying firm. But even the best spin doctors will have trouble explaining this one.

KV's actions are unconscionable. They have been condemned by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

Few situations are more worrisome for a couple than a diagnosis of a complicated pregnancy. This anxiety shouldn't be heightened by the worry of how to pay for a once-affordable treatment.

We must not let this treatment slip out of reach. The lives of too many babies hang in the balance.

Sherrod Brown is a Democratic senator from Ohio.