ARTICLE | Politics & Policy

E&C subcommittee advances bill on pre-approval communications

January 18, 2018 10:11 PM UTC

In a markup session Wednesday, the health subcommittee of the House Energy & Commerce Committee voted to send the Pharmaceutical Information Exchange Act to the full committee. The bill clarifies how drug and medical device companies can share economic or scientific information with entities such as payers or formularies prior to FDA approval.

Specifically, the bill would allow product developers to share information relating to investigational use of an approved drug if preclinical and clinical studies to support the new use have been completed and a supplemental application is either planned or submitted. Information relating to an unapproved product or device can be shared if it is based on preclinical and clinical data that will be used for FDA approval, clearance or licensing...