The $5-per-pill price URL Pharma set for Colcrys surprised the FDA, says Levy. Responding to complaints about the price it is charging, the company has established an extensive patient access program, under which patients earning up to $134,000 per year can get their drugs for as little as $25 per month. The company says 50,000 patients have signed up for the program, but it's hard to know what percentage of gout and FMF patients that represents; between 1 million and 2 million colchicine prescriptions are written each year.
The FDA seems, understandably, taken aback by criticism of its role in Colcrys. "I don't want the forest to get lost for the trees,'' Levy told me. "It's extremely important that these older drugs get approved. If you look at our data on these drugs, they pose a serious safety risk to the American public."
Indeed, few would dispute the value of the FDA's drive to ensure the safety and efficacy of prescription drugs. But both URL Pharma and K-V Pharmaceuticals seem to be reaping rewards out of proportion to their investments. At a time when states are cutting Medicaid payments and everyone is being asked to tighten belts, this isn't fair and doesn't make sense. Alternative methods for improving the safety and efficacy of these drugs aren't obvious. Hopefully, in investigating the price hikes, Congress will look for legislative remedies to improve the drug supply without costing the public an arm and a leg.
Correction, March 29, 2011: This article originally misidentified the manufacturer of Colcrys as Pharma URL. The company's name is URL Pharma. (Return to the corrected sentence.)