1. Short title This Act may be cited as the Saving American Families through Efficacy and Trusted Ways Act of 2018 or the SAFETY Act of 2018 . 2. Consideration of potential for misuse and abuse required for drug approval (a) In general Section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) ) is amended— (1) in the first sentence— (A) by striking or (7) and inserting (7) ; and (B) by inserting ; or (8) if the drug is or contains a controlled substance for which a listing in any schedule is in effect under the Controlled Substances Act or that is permanently scheduled pursuant to section 201 of such Act, on the basis of information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, the drug is unsafe for use due to the risks of abuse or misuse or there is insufficient information to show that the drug is safe for use considering such risks; before he shall issue an order refusing to approve the application ; and (2) in the second sentence, by striking (6) and inserting (8) . (b) Withdrawal authority Section 505(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(e) ) is amended in the first sentence— (1) by striking or (5) and inserting (5) ; and (2) by inserting the following: