Urges FDA to Finalize Regulations on Expanded Access
June 25, 2008
Andrew von Eschenbach,
Dear Dr. von Eschenbach:
The undersigned cancer patient advocacy, provider and research organizations are writing to express our concern regarding the delay of the Food and Drug Administration in issuing final rules on expanded access programs and limits on charging for investigational products (Docket Nos. 2006N-0061 and 2006N-0062). The proposed rules were published more than a year ago, on December 14, 2006, and the comment period closed on March 14, 2007. Once again, the Cancer Leadership Council strongly supports and eagerly anticipates the prompt issuance of these rules in final form.
The adoption of the expanded access program outlined in the proposed rule would be responsive to the needs of cancer patients seeking access to investigational treatments. Moreover, the rule on charging for investigational drugs will enhance patient opportunities to access those new products and to participate in clinical trials. We do not understand why the agency does not move expeditiously to finalize these measures.
We request your personal attention to publication, without further delay, of the final rules regarding these important matters. Thank you in advance for your assistance in this regard.
cc: The Honorable Mike Leavitt
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