S.Amdt. 3384

SA 3384. Mr. MARKEY submitted an amendment intended to be proposed by
him to the bill S. 524, to authorize the Attorney General to award
grants to address the national epidemics of prescription opioid abuse
and heroin use; which was ordered to lie on the table; as follows:

At the end, add the following:

SEC. 705. ADVISORY COMMITTEE FOR APPROVAL OF NEW OPIOID
DRUGS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) is amended by adding at the end the following:
``(y) Advisory Committee Regarding Opioid Drugs.--
Notwithstanding any other provision of this Act, the
Secretary shall convene a panel of experts, which shall
expressly consider the issues of addiction, abuse, and
dependence--
``(1) to review an application submitted under subsection
(b) or (j) for a new drug that is an opioid before the
Secretary may approve such application; and
``(2) to review a supplement to an application approved
under this section for a drug that is an opioid before the
Secretary may approve such supplement.''.
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