A stink was raised a few years back when the FDA asked for a safety study of colchicine, an inexpensive drug that had been prescribed for decades for gout, then granted exclusive approval to one company who stepped up. As soon as the approval was in place, the price of the drug went up from pennies per pill to $5 and patients and doctors screamed foul. Now some researchers have looked into the unintended consequences of that action and found the agency made things worse for patients with the painful condition, with no benefit.
"The way this case was handled has led to a potentially useful drug, colchicine, being prescribed to fewer patients, while there have also been substantial cost increases for those who do use it and no evidence of reductions in unsafe co-prescriptions," says Aaron Kesselheim, of Brigham and Women's Hospital and the Harvard Medical School. Kesselheim led the study that appears in the Journal of General Internal Medicine and conclude that the FDA's action has been costly and problematic, writes News Medical.
Colchicine was the primary treatment for a rare inflammatory disease called familial Mediterranean fever but for years was sold at very low cost and widely used to treat gout. But the drug had predated the FDA's 1962 authority to oversee safety and so had never been evaluated. In 2007, the FDA asked manufacturers to look at its safety but only URL Pharma decided to take on the challenge, and the cost of a study. The FDA granted exclusive approval to URL's version, called Colcrys, and made other manufacturers quit producing theirs. URL responded by jumping the price from $0.09 to $5 per dose, which brought immediate protests.
The FDA defended its actions, in part, by pointing to a new warning in Colcrys' label citing the potentially lethal risks of prescribing colchicine along with the antibiotic clarithromycin.
So what did Kesselheim and his colleagues find when they reviewed the records of 217,000 commercially insured patients between 2009 and 2012 who had been newly diagnosed with gout or familial Mediterranean fever? Both groups were less likely to get prescribed the drug. Those who did get it saw their average cost go up each month by $233 to $651. As for potential interactions? There was no change in the percentage of patients were prescribed both colchicine and clarithromycin.
The FDA decision was "costly and potentially problematic," the researchers said, according to New Medical.
The FDA has been through this all before, but with different results. The FDA in 2011 approved Makena, a drug for women who suffered premature birth but which most women had gotten for $15 a dose from compounding pharmacies before the approval. K-V jumped the drug to $1,500 a dose. When there were protests, the FDA decided not to ban the compounded version. K-V sued the FDA and lost and ended up for a while in bankruptcy while it reworked its business model.
- read the release