115 S3420 IS: Accountability in Opioid Advertising Act U.S. Senate 2018-09-06 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II 115th CONGRESS2d 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.