FDA's campaign against unapproved drugs is having some unexpected side effects. Just look at Colcrys, a new-old drug for gout. The Wall Street Journal reports that when the FDA acted against makers of colchicine, a gout drug that predated the agency, it created an opportunity for drugmaker URL Pharma to swoop in to test a version of the drug, get FDA approval--and put a brand-name price on it.
The unapproved colchicine price ran as low as pennies per tablet, WSJ reports. But the new, branded version costs up to $5 per tablet. And on top of that, URL is suing some longtime manufacturers of the unapproved version of the drug, accusing them of marketing their products illegally. Some of those are fighting the suits; some have raised the price for their own colchicine versions to more than $1 per tablet. This all means prescriptions are running up to $125 to $150 per month, up from $5 to $10 a month.
URL tells the Journal that it has priced Colcrys in line with other branded gout treatments. Plus, it has introduced some patient-assistance programs to help patients make the switch. Low-income patients can get a three-month supply for $15, and others can get co-pay assistance. The co-pay help doesn't assist insurers, which will have to absorb much of the added cost. For a drug that's been in use since the sixth century, it's quite a switch.
- read the WSJ piece