Off-Label Communications: BIO Lays Ethical Foundation For Change
Industry group's future advocacy around legal and regulatory reforms affecting product sponsor communications with payers and health care providers will align with four bioethical considerations.
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After years of industry prodding, FDA schedules a two-day public meeting in November to establish direction for off-label regulation, but the agency is already being pulled in multiple directions.
Industry communication principles offer best practices for combating contrary evidence, refuting third-party comparative effectiveness analyses and sharing real-world evidence addressing health outcomes and costs.
Manufacturer communications with providers and payers could include real-world evidence and pharmacoeconomic information, associations urge.