FDA approval causes drug price to skyrocket

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

In a collaboration between The Philadelphia Inquirer and Kaiser Health News, Harris Meyer looks at the case of colchicine, a drug used to treat gout that has been on the market so long that it predates the FDA approval process, and thus had never been approved.

Like thousands of drugs it existed in a sort of grandfathered generic state. That ended in 2009 when URL Pharma earned FDA approval for a branded version of the drug, which it sells for 50 times more per pill than the generic.

The drug company convinced the FDA that its version was safer than the generic, a claim disputed by many physicians. Now, Meyer reports, it’s likely that the generic colchicine will be forced from the market over the coming months, driving customers of the centuries-old drug (a natural version was first mentioned by the ancient Greeks) into the arms of URL Pharma. According to Meyer, the case is just one of several that have resulted from post-2006 FDA efforts to gain control and approval over all those grandfathered-in unregulated drugs.

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