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ACCELERATED APPROVAL REG’s NDA WITHDRAWAL RATIONALE SHOULD NOT INCLUDE MISCONDUCT

Executive Summary

ACCELERATED APPROVAL REG's NDA WITHDRAWAL RATIONALE SHOULD NOT INCLUDE MISCONDUCT by sponsors, the American Society of Clinical Oncology maintained in June 12 comments on the proposed FDA policy for accelerated approval of drugs for life-threatening and serious illnesses. "The reasons for employing an accelerated withdrawal of a new agent should not include perceived misconduct by the pharmaceutical company sponsor," states a letter signed by ASCO Public Issues Committee Chairman Harmon Eyre, MD. "Withdrawal of the new treatments for reasons not directly related to patient care undermines the purpose of the proposed regulation," Eyre noted. The reg, published in the April 15 Federal Register, lists six conditions for withdrawal of an accelerated approval product, three of which are based on failure or misconduct by the sponsor ("The Pink Sheet" April 20, p. 8). Use of the expedited withdrawal process outlined in the accelerated approval reg should be confined to "unusual circumstances," Eyre said. ASCO believes that reasons listed by the proposed reg such as failure to perform the required postmarketing study with due diligence or use of promotional materials that are false and misleading are not grounds for withdrawing approval of a drug. * The oncology society states that "at the very least, anticipated withdrawal of a product should be preceded by measures to ensure that patients and their physicians will have an uninterrupted supply until alternative treatment arrangements can be made." ASCO also commented on the proposal to restrict, in some cases, distribution of products to certain facilities or to physicians with special training or experience. This proposal "could be problematic if not administered carefully," the ASCO letter states. ASCO urged FDA "to specify that such restrictions may be time-limited or reviewed periodically in order not to discourage the spread of important new treatments." The ASCO sentiments were echoed in June 12 comments from the National Coalition for Cancer Survivorship. "We do not believe that misconduct by the sponsoring company should result in patients being penalized by denial of access to possibly life- saving treatment," the coalition states. "Patients should continue to have access to products approved under the new procedures unless there is substantial reason to doubt their safety or effectiveness," the group maintained. Comments submitted on June 12 by the San Francisco-based Community Consortium, an association of regional health care providers caring for HIV-infected patients, applaud FDA's efforts to accelerate approval of drugs for serious and life-threatening illnesses. The consortium suggested that FDA might evaluate the impact of the accelerated approval reg "after an 18 to 24 months trial period to determine whether or not any changes should be made in the currently proposed regulation."

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