II 115th CONGRESS 2d Session S. 3420 IN THE SENATE OF THE UNITED STATES September 6, 2018 Ms. Harris (for herself and Mr. Gardner ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the Food and Drug Administration to prioritize the promotional materials for drugs for serious, life-threatening diseases or conditions or substance use disorders, especially opioid drugs and drugs for medication-assisted treatment, in considering whether promotional materials are false or misleading.

1. Short title This Act may be cited as the Accountability in Opioid Advertising Act . 2. Promotional materials for drugs In enforcing section 303(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(g) ) and otherwise ensuring that advertising and other promotional materials for drugs approved under section 505 of such Act ( 21 U.S.C. 355 ), including pursuant to section 503C of such Act ( 21 U.S.C. 353c ), are not false or misleading, the Secretary of Health and Human Services shall give priority consideration to advertising and other promotional materials for drugs for serious, life-threatening diseases or conditions or substance use disorders, especially opioid drugs and drugs for medication-assisted treatment.