H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act. This bill would create a safe harbor that would allow drug and medical device companies to share certain health care economic or scientific information with payers, formularies, and other coverage, reimbursement, and population-based health care decision makers prior to FDA approval. Such information – including clinical and pre-clinical data and results relating to an unapproved drug therapy, or drug indication, or other condition of use being investigated or developed – must be based on competent and reliable scientific evidence and relate to an investigational use of a new drug or device or an investigational use of an approved drug or device.
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