Latest News on Unapproved Colchicine Removal
September 30, 2010
Dear Colleague,
We wanted the membership to be apprised of recent developments with the colchicine issue.
We have continued a dialogue with the FDA since this issue first arose, and on our most recent teleconference, the FDA informed the ACR that it will be taking action to remove unapproved colchicine from the U.S market. Colcrys®, which received FDA approval in July 2009, will be the only form of colchicine available at that time.
The Federal Register announcement, which will be posted on October 1, 2010, states that companies will be forced to cease manufacturing unapproved colchicine within 45 days of notice, and stop distribution within 90 days. The FDA is expected to make an official public announcement this afternoon.
The ACR believes patients should have confidence that the drugs they are taking are safe. Until 2006, colchicine was not required to be FDA approved because it was produced prior to the agency’s requirements for safety, effectiveness, quality and labeling. In 2006, the FDA launched an initiative to require that drugs previously permitted should go through the FDA approval process. While the ACR is supportive of this initiative, the unanticipated increase in cost for colchicine has been extremely disappointing to all of us and our patients.
As you recall, URL Pharma was granted market exclusivity for three years for acute gout, and seven years for FMF. The retail price of Colcrys® is approximately $5/pill while unapproved colchicine was approximately 10 cents a pill. After input with the ACR, URL Pharma enhanced its Patient Assistance Program. Patients who do not qualify for the PAP can receive the drug at $25/month through the Colcrys® co-pay assistance (see ACR website for PAP details). Although this PAP will help patients afford care, the increased financial burden could possibly be reflected on the insured through increased insurance premiums.
Given that no exclusivity exists for the chronic gout prophylaxis indication, the possibility exists for other manufacturers to apply and receive approval for this indication. When we first became aware of the increased cost of colchicine, we contacted manufacturers of unapproved colchicine to encourage new drug applications for FDA approval of chronic gout; over the past week we have renewed our efforts to reach out to remaining manufacturer encouraging them to seek approval. I am pleased to let you know that one manufacturer has stepped forward and has filed a new drug application for colchicine for the gout prophylaxis indication. We are hopeful FDA will conduct an expedited review process so that possible cost relief is available to our patients.
We will update you again when the FDA releases its official announcement on this matter. If you have any questions or comments, please don’t hesitate to contact me at .
Stanley B. Cohen, MD
ACR President
