1. Short title This Act may be cited as the Long-Term Opioid Efficacy Act of 2018 . 2. Postapproval study requirements (a) Purposes of study Section 505(o)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(B) ) is amended by adding at the end the following: (iv) To assess a potential reduction in effectiveness or an increase in serious risk of the drug for the conditions of use prescribed, recommended, or suggested in the labeling thereof if— (I) the drug involved— (aa) is or contains a substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act; or (bb) is a drug that has not been approved under this section or licensed under section 351 of the Public Health Service Act, for which an application for such approval or licensure is pending or anticipated, and for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act; and (II) the potential reduction in effectiveness or the increase in serious risk could result in the benefits of the drug no longer outweighing the risks. . (b) Establishment of requirement Section 505(o)(3)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(C) ) is amended by striking such requirement and all that follows through safety information. and inserting the following: such requirement— (i) in the case of a purpose described in clause (i), (ii), or (iii) of subparagraph (B), only if the Secretary becomes aware of new safety information