S.Amdt. 3343

SA 3343. Mr. MANCHIN 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. APPROVAL OF OPIOID DRUGS.

(a) In General.--Notwithstanding any other provision of
law, the Commissioner of Food and Drugs (referred to in this
section as ``the Commissioner'') shall ensure that, with
respect to each application for an opioid drug submitted
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355)--
(1) an advisory committee of the Center for Drug Evaluation
and Research of the Food and Drug Administration evaluates
the application and issues a recommendation regarding
approval of such drug prior to a final decision to approve
such drug; and
(2) if a final decision to approve such drug is
inconsistent with the recommendation under paragraph (1),
such final decision shall be made by the Commissioner and
shall not be delegated.
(b) Reports to Congress.--If the advisory committee
recommends under subsection (a)(1) that the Commissioner not
approve an opioid drug under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355), and the Commissioner
approves that drug under subsection (a)(2), the Commissioner
shall--
(1) submit a report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, and to any
member of Congress that requests the report, that includes--
(A) medical and scientific evidence regarding patient
safety that clearly supports the Commissioner's decision to
approve the opioid drug against the recommendation of the
advisory committee; and
(B) a disclosure of any potential conflicts of interest
that may exist regarding any official of the Food and Drug
Administration who was involved in the decision to approve
the drug prior to the Commissioner's final decision under
subsection (a)(2); and
(2) at the request of the Committee on Health, Education,
Labor, and Pensions of the Senate or the Committee on Energy
and Commerce of the House of Representatives, testify before
that committee regarding the Commissioner's decision to
approve the opioid drug against the recommendation of the
advisory committee.
(c) Prohibition on Marketing.--A drug described in
subsection (b) shall not be introduced or delivered for
introduction into interstate commerce until the report
described in subsection (b)(1) has been submitted to
Congress.
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