A bill to amend the Federal, Food, Drug, and Cosmetic Act, as amended, to require submission of certain additional information by applicants for new drugs; to require the inclusion of certain additional information in drug labeling; and for other purposes.

Requires, under the Federal Food, Drug, and Cosemtic Act, applicants for new drugs to submit a statement of biological criteria relating to therapeutic effectiveness and safety which the applicant claims should be specially considered by practitioners who dispense such drug.

States that a drug shall be deemed to be mislabeled unless its label contains a statement of biological criteria and performance data.