Unbranded Colchicine Getting Hard to Find

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.

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 and Excellium Pharmaceuticals, 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, 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.

Several physicians said in interviews that although patients are complaining about the higher cost, they can still get the pills. But some physicians are writing larger-than-usual prescriptions to help patients stock up< while others say they will refer patients to the Internet and Canadian pharmacies if they run into trouble.

Two companies, Euro-Pharm International Canada and Odan Laboratories, sell colchicine in Canada, according to Gary Holub, a Health Canada spokesman.

Colcrys sells for about $5 per pill, according to DestinationRx.com

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/NEJMp1003126]).

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.

Because of the latter reason, unbranded colchicine was pulled from Medicare part D formularies this year and was replaced by Colcrys.

Whatever the outcome of the court battles, the situation isn't permanent.

URL's marketing exclusivity for Colcrys's gout indications expires July 30, 2012. The familial Mediterranean fever indication expires July 29, 2016, according to the FDA's Web site.

Disclosures: Dr. Morris disclosed that he is on the speakers' bureau for Takeda, Eli Lilly, and Forest Pharmaceuticals.

Information about URL's Colcrys patient assistance program and copayment coupons are available by visiting Colcrys.com

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.

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 and Excellium Pharmaceuticals, 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, 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.

Several physicians said in interviews that although patients are complaining about the higher cost, they can still get the pills. But some physicians are writing larger-than-usual prescriptions to help patients stock up< while others say they will refer patients to the Internet and Canadian pharmacies if they run into trouble.

Two companies, Euro-Pharm International Canada and Odan Laboratories, sell colchicine in Canada, according to Gary Holub, a Health Canada spokesman.

Colcrys sells for about $5 per pill, according to DestinationRx.com

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/NEJMp1003126]).

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.

Because of the latter reason, unbranded colchicine was pulled from Medicare part D formularies this year and was replaced by Colcrys.

Whatever the outcome of the court battles, the situation isn't permanent.

URL's marketing exclusivity for Colcrys's gout indications expires July 30, 2012. The familial Mediterranean fever indication expires July 29, 2016, according to the FDA's Web site.

Disclosures: Dr. Morris disclosed that he is on the speakers' bureau for Takeda, Eli Lilly, and Forest Pharmaceuticals.

Information about URL's Colcrys patient assistance program and copayment coupons are available by visiting Colcrys.com

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.

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 and Excellium Pharmaceuticals, 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, 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.

Several physicians said in interviews that although patients are complaining about the higher cost, they can still get the pills. But some physicians are writing larger-than-usual prescriptions to help patients stock up< while others say they will refer patients to the Internet and Canadian pharmacies if they run into trouble.

Two companies, Euro-Pharm International Canada and Odan Laboratories, sell colchicine in Canada, according to Gary Holub, a Health Canada spokesman.

Colcrys sells for about $5 per pill, according to DestinationRx.com

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/NEJMp1003126]).

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.

Because of the latter reason, unbranded colchicine was pulled from Medicare part D formularies this year and was replaced by Colcrys.

Whatever the outcome of the court battles, the situation isn't permanent.

URL's marketing exclusivity for Colcrys's gout indications expires July 30, 2012. The familial Mediterranean fever indication expires July 29, 2016, according to the FDA's Web site.

Disclosures: Dr. Morris disclosed that he is on the speakers' bureau for Takeda, Eli Lilly, and Forest Pharmaceuticals.

Information about URL's Colcrys patient assistance program and copayment coupons are available by visiting Colcrys.com