1. Provide the title of your story or series and the names of the journalists involved.
Colcrys Approval Triggers Questions
Kurt Ullman, Writer David Pisetsky, MD – Editor Dawn Antoline, Editor
2. List date(s) this work was published or aired.
May-10
3. Provide a brief synopsis of the story or stories, including any significant findings.
The Food, Drug and Cosmetics Act of 1938 and the Amendments of 1962 charged the Food and Drug Administration (FDA) with approving drugs that are safe and effective. Many medications being sold before the Act are still available, although unapproved. One, of these unapproved medications, colchicine, had been available for years and used in the treatment of for acute gout and Familial Mediterranean Fever (FMF) among others. In June of 2006, the FDA and its Center for Drug Evaluation and Research (CDER) undertook the Unapproved Drugs Initiative to bring more medications into compliance. Under the provisions of the Act the FDA in July of 2009, awarded URL Pharma of Philadelphia approval to market a form of colchicine for acute gout and Familial Mediterranean Fever (FMF). They were given three-year marketing exclusivity for gout and a 7-year term for FMF as an orphan drug. As a result of the exclusivity, the branded version called Colcrys ® sells for about $5.00 a tablet or roughly 50 times the price of the unapproved version. In addition, all other versions of colchicine being marketed were pulled off the market, leaving Colcrys as the only available option. The article reported on the firestorm of protest from the Rheumatologists and patients using colchicine who were now required to pay these higher prices. It looked into the UDI program, what were the insurance implications, the views of URL on the controversy, what programs were put in place by URL and others to help patients pay the higher prices, and the legal underpinnings behind the approval and subsequent removal of other forms of colchicine from the market.
4. Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The NDA for Colcrys. The FDA website for background explanations of the UDI program. Documentary and Website information from URL Pharma on their research leading to the approval of Colcrys.
5. Explain types of human sources used.
Interviewed Michael Levy, Director, Division of New Drugs and Labeling Compliance in the Center for Drug Evaluation and Research (through the Public Information office at the FDA), Chris Morris, MD, a Rheumatologist in private practice in Kingston, Tennessee, URL President and CEO Richard Roberts, MD (arranged through their PR firm), Edward Fudman, MD, a Rheumatologist in private practice in Austin, TX. Kurt Karst, JD, a partner in Hyman, Phelps, and McNamara in Washington, DC.
6. Results (if any).
None recorded.
7. Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
None at this time.
8. Advice to other journalists planning a similar story or project.
None at this time.