June 10, 2011 — The second pharmaceutical company to use the US Food and Drug Administration's (FDA) 2006 Unapproved Drugs Initiative to bring an old drug in from the cold, eliminate competing suppliers, and dramatically raise the price has run into a firestorm from Capitol Hill.
In July 2009, Philadelphia-based URL Pharma Inc, was granted 3 years of marketing exclusivity for Colcrys (colchicine) for acute gout flares, and generic sales were forbidden by the FDA. This approval was made under the Waxman-Hatch Act, based in part on pharmacokinetic studies and randomized controlled trials that studied 185 patients with acute gout. Previously, colchicine has been widely used off label despite lack of formal FDA approval; use of colchicine or its precursors for gout dates back to at least 550 CE.
At the time of the URL Pharma approval, 21 companies were making oral colchicine, and the cost was as low as $0.04 per tablet. In September 2010, the FDA ordered a halt to marketing of unapproved single-ingredient oral colchicines. After obtaining marketing exclusivity, URL Pharma raised the price to $5 per tablet.
US Senator Sherrod Brown has now joined Sen. Herb Kohl and Reps. Henry Waxman, Frank Pallone, and Diana DeGette in charging the company with price gouging.
On June 6 Sen. Brown wrote to Donald Berwick, MD, director of the Centers for Medicare and Medicaid Services, demanding an investigation "of the ramifications of URL Pharma's massive price increase of Colcrys — the branded version of colchicine."
Sen. Kohl and Reps. Waxman, Pallone, and DeGette had previously written to URL Pharma head Richard W. Roberts asking about "the cost of the trials that led to Colcrys's approval, how the list price was established, the marketing budget for the drug, how much it costs to manufacture, and what expected sales and profit are," the Wall St. Journal reported.
According to Sen. Brown, physicians at the American College of Rheumatology report that the standard dose for a person with gout is 2 colchicine tablets per day when a patient is not suffering a gout attack. The dose may increase to treat flare-ups. With 3 million patients with gout averaging 2 pills each day, Brown said URL Pharma would sell nearly $11 billion worth of the medication in 1 year.
"My overarching concern with this price increase is that this seems to be a new model for drug companies," Sen. Brown wrote to the Centers for Medicare and Medicaid Services. "As we saw recently with the drug Makena, companies are cherry-picking medications and treatments that have been widely used but have not gone through the FDA approval process. URL Pharma, KV Pharmaceutical, and others are taking these medications through the approval process with minimal investment and are reaping disproportionate rewards for their work."
URL Pharma responded in a press statement that Sen. Brown has vastly overstated the expected sales of Colcrys, and that the company "has instituted extensive patient assistance programs to provide affordable access to Colcrys."
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Cite this: Outraged Politicians Demand Gout Drug Price Probe - Medscape - Jun 10, 2011.