To amend the Federal Food, Drug, and Cosmetic Act with respect to determining the intended use of drugs and devices.
Medical Product Communications Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to state that the intended use of a drug, biological product, or device shall be determined by the objective intent of the manufacturer and sponsor of such drug, biological product, or device, as demonstrated by statements contained in labeling, advertising, or analogous oral statements.
The intended use of these medical products shall not be determined by actual or constructive knowledge of the manufacturer or sponsor that these products will be used in a manner that varies from the use approved for marketing.
Additionally, the scientific exchange of information about these products shall not constitute labeling, advertising, or evidence of a new intended use. The bill sets forth the requirements for a scientific exchange.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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