Companies that manufacture, distribute, and/or market unapproved formulations of the oral, single ingredient forms of the gout drug colchicine have been ordered to stop doing so, the Food and Drug Administration announced on Sept. 30.
The companies must stop manufacturing these products within 45 days of the announcement and stop shipping unapproved colchicine within 90 days of the announcement, according to the statement, which says that a small amount of unapproved colchicine will be available after these dates, until supplies are used up.
Oral colchicine products are among the drugs that have been on the market for so many years that they were never subjected to the current prescription drug approval process. The FDA has launched an initiative to target the manufacturers of colchicine and other older, unapproved drugs to conduct the necessary testing to meet current approval standards or take them off the market.
Once the older products are off the market, the only oral colchicine product that will be available is Colcrys, marketed by Mutual Pharmaceuticals/URL Pharma, which was approved in 2009, after the company met the current drug approval requirements. As a result, the drug’s label includes information on safety data, drug interactions, and dosing that is not available for the older unapproved versions, according to the FDA.
The FDA's approval of Colcrys and the plans to ban the marketing of the older products has been sharply criticized by some clinicians who treat patients with gout because Colcrys is significantly more expensive than the older, unapproved formulations.
The FDA statement notes that the manufacturer of Colcrys has established a patient assistance program for patients who can’t afford the brand-name drug and those on Medicare who don’t want the cost of the drug to contribute to their out-of-pocket Medicare Part D expenses. More information about that program is available at the Colcrys Web site or at Needy Meds, an umbrella organization that offers patient assistance, or by calling 888-811-8423. The company has said that the program will continue "at a minimum until there is FDA-approved generic competition" for Colcrys, according to the statement.
The agency is encouraging manufacturers of such products to pursue approval of their products or "to face the type of action announced today," Deborah Autor, director of the office of compliance at the FDA's Center for Drug Evaluation and Research (CDER), said in the statement.
The FDA ordered a halt to unapproved colchicine for injection products in 2008.