Remember the brouhaha over the premature birth prevention drug Makena? KV Pharmaceuticals had taken an unapproved drug long-used to prevent premature births, put it through clinical trials, and won FDA approval for it. Then the company gave it a $1,500-per-injection price tag. Next, it notified compounding pharmacies to stop making their own small batches of the remedy, or risk an FDA crackdown.
Cue outcry; the FDA got involved, decreeing that it wouldn't hold those pharmacies to account as long as certain conditions were met, and the company knocked down its price by 55 percent.
Well, here we go again. Some time ago, URL Pharma took a long-used gout drug, colchicine, and ran its version through clinical trials. Branded Colcrys, the company's drug won FDA approval and three years of exclusivity. And it also got a much higher price tag than the old, unapproved versions: more than $5 per pill, versus just pennies, the Wall Street Journal Health Blog reports.
The pricier drug drew fire from the beginning, but now that fire is heating up. Four Democratic Congressmen have written to URL's chief executive demanding some back-up for the company's higher price on a long used drug. They've asked for the cost of the trials necessary to win FDA approval, the marketing budget for the drug, its manufacturing costs, and projected sales and profits, the Health Blog notes. The lawmakers are looking for a response by June 10.
- see the Health Blog post