Preapproval Information Exchange Between Sponsors, Insurers Clarified In House User Fee Bill
By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.
You may also be interested in...
Final guidance on drug manufacturer communications with payors adopts industry call to include exchanges about unapproved uses; they will not be considered evidence of intended use.
Safe harbor for off label discussions between manufacturers and payers clears US House Energy & Commerce Health Subcommittee. Bill covers unapproved drugs as well as off label uses for approved agents.
Draft guidance provides clarity on what health care economic information firms can provide to payors, formulary committees and similar entities.