Off-Label Communication Growth: Could FDA Afford To Police It?
Another user fee for the US drug agency could help pay for research of off-label uses, but lack of resources could be a regulatory problem.
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Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.
As sponsors push for more access to physicians, payers hope to be able to gather more pre-approval information about drugs – like they now can with devices – for budgeting and patient access.
Prescribers can get information they need through continuing education programs and scientific conferences, non-industry stakeholders tell US FDA during second day of meeting on manufacturer communications for unapproved uses.