December 29th, 2009

Philadelphia Inq report:

Doris Webb was diagnosed earlier this year with a rare disease called Familial Mediterranean Fever, a hereditary condition that causes fevers, arthritis attacks, and inflammation of the lining of the lungs and abdomen. Debilitating pain in her joints and bones was relieved by a prescription drug called colchicine.

Webb, of Morristown, Tenn., takes two to three tablets a day, paying $11 at Wal-Mart for a 90-day supply, according to her daughter, Tina Martin, who also takes colchicine for FMF. The drug, which has long been used to treat gout, is cheap; like thousands of prescription drugs, it predates modern drug laws and is not approved by the Food and Drug Administration.

Webb, 66, who’s on Medicare but cannot afford the Part D drug benefit, faces a problem in getting her colchicine. In July, Philadelphia-based URL Pharma won FDA approval for a branded version called Colcrys, which sells for about $4.50 a tablet – nearly 50 times the price of the unapproved version. While the uninsured will be hit hardest by the cost increase, even insured patients, like Martin, will face higher costs. She says her co-payment will rise from $10 to $35 for a 90-day supply.

The FDA found that Colcrys’ drug-interaction labeling and recommended dosing regimen make it safer than the unapproved forms of colchicine. The agency said it had received reports of 120 patient deaths from interactions of unapproved colchicine with other drugs. It granted URL Pharma and Colcrys three years exclusivity for treatment of gout – a recurrent arthritic inflammatory disease caused by uric-acid buildup.

Click here to read article