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One of the oldest, most effective and widely used drugs for the treatment of gout is colchicine, used for about 200 years and prescribed over 3 million times last year in the U.S. Because the drug was available from many companies as a generic product, the price for all of these was about 4 cents per pill, until very recently.
Along came one of the generic manufacturers, URL Pharma, which submitted new studies on the drug’s safety and effectiveness to the Food and Drug Administration (FDA)....
One of the oldest, most effective and widely used drugs for the treatment of gout is colchicine, used for about 200 years and prescribed over 3 million times last year in the U.S. Because the drug was available from many companies as a generic product, the price for all of these was about 4 cents per pill, until very recently.
Along came one of the generic manufacturers, URL Pharma, which submitted new studies on the drug’s safety and effectiveness to the Food and Drug Administration (FDA). The URL Pharma studies confirmed the safety and efficacy of its colchicine and that it should not be used with other medicines.
In July 2009, the company received FDA approval to exclusively market colchicine for gout attacks for three years. The company was taking advantage of an FDA effort to get companies to test drugs that were already on the market before the FDA existed by granting exclusive marketing rights if a drugmaker conducts clinical trials.
Shortly after the FDA’s approval of URL Pharma colchicine, with the brand name COLCRYS, two things happened: First, the price for the new brand-name version was set at around $5 a pill, roughly 125 times more expensive than the previous generic versions. Then, one generic version disappeared because URL Pharma sued companies to get their drugs off the market, arguing that, since COLCRYS was now the exclusive version of colchicine approved by the FDA, the companies were illegally marketing their products.
Other companies are fighting against the URL Pharma lawsuit. But generic manufacturers now have cause for additional concern, because in October 2010 the FDA threatened to take enforcement actions against all manufacturers other than URL Pharma in effort to get their products off the market.
Writing in The New England Journal of Medicine a year ago, Harvard physicians Aaron Kesselheim and Daniel Solomon had this to say about the FDA rewarding URL Pharma with market exclusivity:
“In addition, it is important to remember that the financial burden of market-exclusivity incentives in the United States falls primarily on the patients who are given prescriptions for the drug, or their insurers. Consequently, it seems reasonable to expect that costly new drugs or increases in drug prices would be accompanied by a substantial benefit in disease management to be enjoyed by these patients. This standard is not met by COLCRYS.”
In association with a letter urging an investigation of this matter by the Centers for Medicare & Medicaid Services (CMS), part of the Department of Health and Human Services, Sen. Sherrod Brown (D-Ohio) said:
“Yet again, a pharmaceutical company is taking advantage of FDA approval to price-gouge their customers and pad their profits. Because most Americans living with gout are seniors — and the average Social Security recipient receives just around $14,000 per year — a price hike to more than $3,500 per year will break the budgets of so many who depend on this drug. URL Pharma should do the right thing and put patients over their profits — particularly since their patients are those who can least afford a colossal price increase.
“Furthermore, the Centers for Medicare and Medicaid Services need to investigate this cost hike. With more than 3 million Americans suffering from gout, the price hike for colchicine will no doubt have a significant impact on Medicare.”
Brown also asked the government to focus on the larger issue of “companies’ cherry-picking medications and treatments that have been widely used but have not gone through the FDA approval process. URL Pharma ... and others are taking these medications through the approval process with minimal investment and are reaping disproportionate rewards for their work.”
Rheumatologists, who treat a large proportion of patients with gout, have also weighed in on this dispute. Stanley Cohen, a Dallas, Texas, doctor who is the president of the American College of Rheumatology, met with the FDA to express concern about the price increase. He told The Wall Street Journal, “It’s not a new product. It’s been out for hundreds of years. To all of a sudden have to pay $125 or $150 a month, after it only cost $5 or $10 a month, is a real problem.”
