Colchicine - Marketing Exclusivity in The United States

Marketing Exclusivity in The United States

As a drug predating the FDA, colchicine was sold in the United States for many years without having been reviewed by the FDA for safety and efficacy. In 2009, the FDA reviewed an NDA submitted by URL Pharma and approved colchicine for gout flares, awarding Colcrys a three-year term of market exclusivity, prohibiting generic sales, and increasing the price of the drug from $0.09 to $4.85 per tablet.

Numerous consensus guidelines, and previous randomized controlled trials, had concluded that colchicine is effective for acute flares of gouty arthritis. However, as of 2006, the drug was not formally approved by the FDA, owing to the lack of a conclusive randomized control trial (RCT). That year, the FDA started an Unapproved Drugs Initiative, through which they sought more rigorous testing of efficacy and safety of colchicine and other unapproved drugs. In exchange for paying for the costly testing, the FDA gave URL Pharma three years of market exclusivity for its Colcrys brand, under the Hatch-Waxman Act, based in part on URL-funded research in 2007, including pharmacokinetic studies and a randomized control trial with 185 patients with acute gout. URL Pharma also received seven years of market exclusivity for Colcrys in treatment of familial Mediterranean fever, under the Orphan Drug Law. URL Pharma then raised the price per tablet from $0.09 to $4.85 and sued to remove other versions from the market, increasing annual costs for the drug to U.S. state Medicaid programs from $1 million to $50 million. Medicare also paid significantly higher costs—making this a direct money-loser for the government. (In a similar case, thalidomide was approved in 1998 as an orphan drug for leprosy and in 2006 for multiple myeloma.)

In April 2010, in an editorial in the New England Journal of Medicine (NEJM), A.S. Kesselheim and D.H. Solomon said that the rewards of this legislation are not calibrated to the quality or value of the information produced, that there is no evidence of meaningful improvement to public health, that it would be much less expensive for the FDA, the National Institutes of Health or large insurers like medicare and medicaid or coalitions of private insurers to pay for trials themselves. Furthermore, the cost burden of this subsidy falls primarily on patients or their insurers. URL Pharma posted a detailed rebuttal of the NEJM editorial.

In September 2010, the FDA ordered a halt to marketing unapproved single-ingredient oral colchicine.