Dear Jim:
Thank you for writing to the Food and Drug Administration (FDA). This is in response to your electronic inquiry dated November 10, 2009, to Dr. Margaret Hamburg, Commissioner, concerning the access to ipilimumab for compassionate use. Your letter was forwarded to my office in the Center for Drug Evaluation and Research (CDER) for a response.
Apparently, the drug's sponsor (BMS) has suspended their Treatment investigational new drug application (IND) because of inadequate supply of the drug. All of their production is being funneled to their clinical trials.
There were a number of individual patient protocols providing treatment access outside of the clinical trials. FDA and the company worked together to consolidate the individual INDs into a Treatment IND, but then found that demand was outstripping supply.
So, currently, there is apparently no expanded access program ongoing. FDA does not have authority to require the company to provide the product outside of their trials. Generally, it's more advantageous to dedicate limited product to clinical trials to establish safety and effectiveness and get the drug to market to provide the widest patient access.
Unfortunately, the FDA cannot readily affect a company's decision to provide patients with continued access under the Treatment IND.
The only real option is to contact the sponsor to convince them to consider reinstating an access program for desperately ill patients. The agency can make the regulatory pathway to access available, but the decision to produce and distribute the product lies solely with the sponsor.
Wish we could have been more help.
Sincerely,
Donald Dobbs
Consumer Safety Officer
Division of Drug Information
Office of Communications
Center for Drug Evaluation and Research
So we must put the Pressure on the sponsor, Bristol-Meyer Squibb
Take Care,
Jimmy B
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