As URL Pharma Inc. and other drug companies battle in court over access to the U.S. colchicine market, the supply of unapproved colchicine is beginning to decline, and patients in at least one small town are scrambling to find what’s left.
“It’s harder to get,” Dr. Christopher Morris, a rheumatologist in Kingsport, Tenn., said in an interview. “Some [patients] have had to go to two or three different pharmacies to find it. Some are going online to find it. Some pharmacies only have Colcrys available,” he added.
The situation started last summer when the Food and Drug Administration approved URL’s colchicine (Colcrys) for gout and familial Mediterranean fever.
URL was the first company to submit colchicine for approval and, under FDA regulations, the company was granted multiyear marketing exclusivity for its efforts.
After the approval, URL went to court to end its competitors’ sales on the grounds that by marketing their colchicine, they falsely imply that it is FDA approved.
Instead, unapproved colchicine was grandfathered into the marketplace by the Food, Drug, and Cosmetic Act of 1938.
Two manufacturers of unbranded colchicine, Vision Pharma LLC and Excellium Pharmaceuticals Inc., were no longer supplying the U.S. market at the end of April, according to the American Society of Health System Pharmacists’ drug shortage Web site.
A third, West-Ward Pharmaceutical Corp., was still doing so, according to the Web site.
The unapproved colchicine business had been growing until now; 1.2 million retail prescriptions were written for it in the first 4 months of this year, compared with 1.1 million for the same period last year and 1 million during the first 4 months of 2008, according to SDI Health LLC, a health care market insight and analytics firm.
Meanwhile, the price of unbranded colchicine has gone from a nationwide average of 19 cents per pill in 2008 to 44 cents, according to SDI.
West-Ward, Vision, and Excellium declined to comment for this story, citing ongoing litigation.
Stocking up
Physicians are bracing for an unbranded colchicine shortage.
Physicians in Cleveland; Austin, Tex.; and New York City said in interviews that although patients are complaining about the higher cost, they can still get the pills.
But anticipating dwindling supplies, Dr. Edward Fudman, a rheumatologist in Austin, said he is writing larger than usual prescriptions to help his patients stock up.
Dr. Brian Mandell, a Cleveland Clinic rheumatologist, said he will refer patients to the Internet and Canadian pharmacies if they run into trouble.
Two companies, Euro-Pharm International Canada Inc. and Odan Laboratories Ltd., sell colchicine in Canada, according to Gary Holub, a Health Canada spokesman.
Another Alternative
Colcrys sells for about $5 per pill, according to DestinationRx.com.
But URL has both a patient assistance program and a copay coupon program to help eligible patients. In this way, the company has taken steps to “ensure everyone in need of Colcrys therapy can get it regardless of income level,” a spokesperson said.
The Colcrys patient assistance program is tiered. A 30-day supply of Colcrys, for example, is free for households with an annual income of up to three times the federal poverty level ($66,150 per year for a family of four), a URL spokesperson said.
Assistance is available for households up to six times the federal poverty level ($132,000 per year for a four-member family).
Under the coupon program, the cost is no more than $25 for prescription of 30 pills or more, the spokesman said.
With Changes Come Tension
Even so, the changes in the U.S. colchicine market have brought tension, with strong opinions among those involved.
Doctors have said that their patients have safely used unapproved colchicine for decades, and that the higher price of Colcrys will limit patient access and drain public health programs (N. Engl. J. Med. 2010 April 21 [doi:10.1056/NEJMp 1003126]).
There have also been calls for the FDA to tighten its marketing exclusivity regulations, and concern that the agency will remove unapproved colchicine from the market as part of its goal to ensure that drugs sold in the United States are tested for safety and efficacy.
In response, URL asserts that the marketing of unbranded colchicine is illegal.
The company also points to a March letter from Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, to the American College of Rheumatology. The letter stated that Colcrys approval studies generated important new information about how to safely use colchicine, and that the safety, purity, and efficacy of unapproved drugs cannot be guaranteed.