Aiom’s complaint: Aifa decides alone on oncological drugs
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After the first meeting last January, the working group set up by the Italian Medicines Agency (AIFA) in the field of oncology, to support the work of the Commissions, has never been met again. “So the oncologists who had been called to be part of it were forced to resign, due to the persistent and unexplained impossibility of meeting to provide the expected collaboration”, underlines the National Board of the Italian Oncology Association in a note Medica (AIOM) who thanks the professionals who had declared themselves available, with significant personal commitment, to be part of the working group and agrees with the decision relating to resignation.
“While in full compliance with the necessary operational autonomy of AIFA – continues the AIOM Board, we believe it penalizing that the regulatory decisions on oncological drugs of the AIFA Commissions are taken without preliminary support conducted in transparency by experts external to the agency, who can provide elements of context and merit useful for generating balanced decisions by the members of the Commissions themselves. AIOM hopes that AIFA will review its modus operandi in this context and obviously remains open to any form of future collaboration, in order to make the regulatory evaluation process of oncological drugs as shared as possible”.
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