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The FDA’s Initiative for Removing Unapproved Drugs Targets Oral Colchicine
by admin on: June 13th, 2011

The U.S. Food and Drug Administration (FDA) continues to broaden their scope in order to bring drugs that are currently being marketed ??? but are unapproved ??? into focus. The goal is to either remove these products from the marketplace or see that they are brought up to current quality standards.

Single-ingredient colchicine is the latest drug to attract the attention of the FDA. In 2008, the FDA took action against colchicines injection products that were unapproved. In September of 2010, the FDA targeted oral formulations of single-ingredient colchicine. This drug has a history (that spans decades) of being commonly used as a prevention for the occurrence of gout. In addition, this drug has been used to treat acute flare-ups of gout and to treat Familial Mediterranean Fever (FMF).

Of note, Colcrys is the only single-ingredient colchicine product on the U.S. market that has the approval of the FDA. Colcrys is manufactured by Mutual Pharmaceutical/URL Pharma and this company has agreed to enact a program (referred to as a Patient Assistance Program, or PAP) that will continue to provide patients with affordably priced oral colchicine product. Patients that will benefit from the PAP include patients that do and do not have insurance. The PAP also helps Medicare beneficiaries who are currently enrolled in Part D, and do not want the cost of purchasing Colcrys to impact their out-of-pocket expenses, which affects Part D of their Medicare benefits.

According to the statement released by the FDA, companies that are manufacturing unapproved single-ingredient colchicine were to stop manufacturing this product by mid-October 2010, and were to halt shipping of this product by the end of the year.

Of course, it is possible that a small amount of this product is still available, but it will be short-lived. As mentioned above, the purpose of this FDA initiative is to improve the quality of the products marketed to the American people, as well as ensure that each product is saf, efficacious, and contains proper labeling.

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