Urges Favorable Consideration of Citizen Petition on Expanded Access Programs
June 12, 2006
Dear Dr. von Eschenbach:
On March 27, 2006, a Citizen Petition (attached) was filed with the Food and Drug Administration (FDA) to urge that the agency issue new guidance regarding the availability and contours of expanded access programs to allow access to unapproved drugs for patients not participating in clinical trials. The undersigned organizations write to express their support for the recommendations contained in the Citizen Petition and to encourage FDA to act promptly to issue the recommended guidance.
We believe that the Citizen Petition, submitted by the National Coalition for Cancer Survivorship (NCCS) and American Society of Clinical Oncology (ASCO), strikes the appropriate balance between expanding access to unapproved therapies and preserving the important role of clinical trials in determining the safety and efficacy of new drugs. The proposed guidance emphasizes the sufficiency of current legal and regulatory authorities to support meaningful expanded access programs while pointing out ways in which patients, providers and sponsors can be better educated about the opportunities and responsibilities associated with those programs. Responsible and responsive expanded access programs give hope to patients without undermining the central role of clinical trials in the drug development process.
Cancer Leadership Council
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