Companies that make unapproved versions of the drug colchicine, which is used to treat and prevent gout and familial Mediterranean fever, were ordered in 2010 by the U.S. Food and Drug Administration (FDA) to discontinue manufacturing these pills within 45 days and to stop shipping them within 90 days.
The action means that within a few months, as pharmacies run through their supplies, the only kind of colchicine likely to be available to consumers will be a brand name version approved in 2009 called Colcrys.
So-called unapproved medications like colchicine are drugs that have been used by doctors since before the FDA began reviewing and approving new therapies in the 1960s, and they include medical mainstays like the painkiller morphine.
The FDA contends that these drugs may put patients at risk because they’ve never been reviewed for safety. Since 2006, regulators have been pushing companies that make and sell these older medications to put them through the rigorous approval process, which includes studying medications in clinical trials. In return, the manufacturers are promised market exclusivity for a period of time so they can recoup their supposed investments in the drugs.
The upside for consumers is that this effort will almost certainly help to identify potential dosing issues and drug interactions that were previously unknown to doctors and pharmacists.
The downside is that these unapproved medications, which are typically priced like generic drugs, will become much more expensive. In the case of colchicine, the retail price of the approved version, Colcrys, jumped from $.10 to $5 per pill.
After a chorus of criticism from doctors and patients, the manufacturer of Colcrys added patient assistance programs that provide substantial price breaks for people hit hard by the increase.
The American College of Rheumatology, or ACR, has been encouraging other pharmaceutical companies to create more market competition for Colcrys; and on Sept. 30, 2010, Stanley Cohen, MD, the president of ACR, announced that a second drug company would apply to the FDA for the right to sell a branded form of the drug.