“One company chose to seek FDA approval and they spent tens of millions of dollars in order to present data necessary for that approval and in the process, there were some important things that came out of the approval process,” Autor said. “We discovered a lot of people were being excessively dosed with Colchicine.”
Unlike companies that develop drugs from scratch and study thousands of patients for years, URL Pharma started with a pre-existing drug. Its research did clarify safety and dosing information. In return for the studies, the FDA granted URL exclusive rights to sell the medication.
“The reward that they got seems far out of proportion to the work that they did,” said Dr. Edward Fundman, a rheumatologist who’s been prescribing Colchicine for 30 years.
Fundman said the conversations among his colleagues was, “Just outrage that a company could take advantage of this FDA process and basically appropriate the drug for its own purpose. Even if a patient’s not paying the full price out of pocket, their insurance company’s paying it. Medicaid and Medicare have to pay for it. We’re all paying for it.”
via FDA approval of ancient remedy sends price soaring – CBS News.