Happy Ending For Preemie Drug Price Hike Saga

Funny thing happened after the FDA approved Makena, a drug that helps prevent premature births: The price went from $10-$20 a dose to $1,500, which would bring the average total price tag to $30,000.

The compound had long been available through pharmacies, but doctors worried about it being unregulated, which is why the March of Dimes supported KV Pharmaceutical’s bid to the FDA. That backfired when they jacked up the price, claiming they’d had to spend all sorts of money to get approved, even though the major study behind it was funded by taxpayers. The worst part was when KV Pharmaceutical sent a letter telling pharmacies they had to back off: “Continuing to compound this product after FDA approval of Makena renders the compounded product subject to FDA enforcement for violating certain provisions of the Federal Food, Drug and Cosmetic Act, as well as FDA guidance,” the letter says.

George Saade, president of the Society for Maternal-Fetal Medicine, told The Washington Post, “It’s not like this drug is something they invented. I think the company is taking advantage of their FDA approval and their monopoly to make money.”

The good news is, the coverage and the outrage by the doctors and online activists have led the FDA to intercede as much as it can. They can’t affect how much companies charge, they said, but did announce today that they wouldn’t enforce any actions against pharmacies that manufacture the compound cheaply.

This brings us, roughly, where we started, except that at least doctors now have better backing for usage of the compound, also known as 17P. And KV Pharmaceutical might have to budge on its price, now that its monopoly is undermined. Score one for pregnant women and the people who care about them.

FDA To Allow Cheaper Preterm Baby Drug [WP] Critics Slam Cost Of FDA-Approved Drug To Prevent Preterm Births [WP]