Some of those of who received the letter described it variously as “intimidating,” “threatening,” and “offensive.” Dr. Hoch initially withdrew her participation in this article after receiving the letter, saying that she “felt intimidated from commenting on this at all, and that I feel my freedom of speech has been violated.”
Kurt Ullman is a freelance medical journalist based in Indiana.
References
- Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High-vs low-dosing of oral colchicine for early acute gout flare: Twenty-four hour outcome results of the first randomized, placebo-controlled, dose comparison colchicine trial. Arthritis Rheum. 2010;62:1060-1068.
- Imboden J, Hellmann D, Stone J, eds. Current Rheumatology Diagnosis & Treatment. 2nd ed. New York: McGraw-Hill (Lange Medical Publications); 2007.
Unapproved Drugs Drawing FDA Attention
The Food, Drug, and Cosmetics Act of 1938 and its 1962 amendments charged the FDA with approving medications based on safety and efficacy. At the time, there were a number of drugs already available.
“In both laws there were grandfathered medications,” says Kurt Karst, JD, a partner in Hyman, Phelps, and McNamara in Washington, DC. “The law said that only medications retaining the formulation and labeling from pre-1938 were grandfathered. The FDA doesn’t believe any drug qualifies.”
The laws required the FDA to review and approve medications already being marketed—and colchicine is one such unapproved product.
Colchicine Awaiting Approval Since 1938
“Colchicine has been out there waiting for someone to seek approval since 1938,” says Karst. “Prior to the appearance of URL Pharma, it was officially an unapproved drug. [URL Pharma has] satisfied the requirements for approval and has been given market exclusivity for a period of time.” An this is not the first time in recent memory that a company has obtained approval for an unapproved, pre-1938 drug. He points to guaifenesin and quinine as examples.
Karst says URL Pharma may be successful in getting other versions of colchicine off the market. The FDA is sending out warning letters to other makers telling them to stop making colchicine.
“Unapproved” Not Same As “Generic”
Legally, other versions of colchicine remain unapproved. This is very different from generic medications, which have gone through their own approval process at the FDA.
“It is important to note that there are no ‘generic’ colchicine products,” writes Levy in an e-mail response to questions. “By definition, generic drugs are those evaluated and approved by the FDA to demonstrate to a brand name reference product. These colchicine products have not been evaluated and approved by the FDA. They are therefore unapproved drugs, not generic medications, and neither their safety nor their efficacy can be ensured.”
