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II
117TH CONGRESS
1ST SESSION
S. 1439
To establish procedures regarding the approval of opioid drugs by the Food
and Drug Administration.
IN THE SENATE OF THE UNITED STATES
APRIL 28, 2021
Mr. MANCHIN (for himself, Mrs. CAPITO, and Mr. KING) introduced the fol-
lowing bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
A BILL
To establish procedures regarding the approval of opioid
drugs by the Food and Drug Administration.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘FDA Accountability
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for Public Safety Act’’.
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SEC. 2. APPROVAL AGAINST THE RECOMMENDATION OF
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THE FDA ADVISORY COMMITTEE ON OPIOID
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DRUGS.
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(a) IN GENERAL.—Any approval of an application or
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supplement to an application under section 505(b) of the
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•S 1439 IS
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b))
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for a drug that is an opioid against the recommendation
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of the advisory committee pursuant to section 106 of the
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Comprehensive Drug and Recovery Act of 2016 (Public
4
Law 114–198) shall be made by the Commissioner of
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Food and Drugs (referred to in this section as the ‘‘Com-
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missioner’’) and shall not be delegated.
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(b) REPORTS TO CONGRESS.—If the Commissioner
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approves a drug as described in subsection (a), the Com-
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missioner shall—
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(1) submit a report to the Committee on
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Health, Education, Labor, and Pensions of the Sen-
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ate and the Committee on Energy and Commerce of
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the House of Representatives, and to any member of
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Congress that requests the report, that includes—
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(A) medical and scientific evidence regard-
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ing patient safety that clearly supports the
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Commissioner’s decision to approve the opioid
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drug against the recommendation of the advi-
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sory committee; and
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(B) a disclosure of any potential conflicts
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of interest that may exist regarding any official
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of the Food and Drug Administration who was
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involved in the decision to approve the drug
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•S 1439 IS
prior to the Commissioner’s final decision under
1
subsection (a); and
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(2) at the request of the Committee on Health,
3
Education, Labor, and Pensions of the Senate or the
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Committee on Energy and Commerce of the House
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of Representatives, testify before that committee re-
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garding the Commissioner’s decision to approve the
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opioid drug against the recommendation of the advi-
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sory committee.
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(c) PROHIBITION ON MARKETING.—A drug approved
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as described in subsection (a) shall not be introduced or
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delivered for introduction into interstate commerce until
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the report described in subsection (b)(1) has been sub-
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mitted to Congress.
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(d) SCOPE OF ADVISORY COMMITTEE REVIEW.—Sec-
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tion 106(a)(1)(A) of the Comprehensive Addiction and Re-
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covery Act of 2016 (Public Law 114–198) is amended—
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(1) by inserting ‘‘, or supplement to an applica-
18
tion,’’ after ‘‘application’’ each place such term ap-
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pears; and
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(2) by striking ‘‘of a new’’ and inserting ‘‘for
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a’’.
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Æ
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