Happy Ending For Preemie Drug Price Hike Saga
LatestFunny 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.