There was an unfortunate series of letters involving the ACR – among them are communications from the American College of Rheumatology (ACR) to FDA and between ACR and URL Pharma. Finally, there is a statement of facts from FDA regarding Colcrys and unapproved colchicine. We regret the need to publish these letters in sequence here but we feel compelled to do so to correct the record for those who are interested in investigating this matter further. A complete reading of this set of letters is quite enlightening.
- Letter from ACR to FDA dated December 18, 2009
- Letter from CEO of URL Pharma to ACR dated February 16, 2010
- Letter from ACR to URL Pharma dated March 24, 2010
- Letter from URL Pharma to ACR dated March 29, 2010
- FDA Statement of Position Letter on Unapproved Colchicine dated March 3, 2010 from the FDA Center for Drug Evaluation and Research