What This Bill Does
This bill creates special rules for when the Food and Drug Administration approves opioid drugs (powerful pain medications) against the advice of an expert advisory committee. The bill requires the FDA's Commissioner to personally make these decisions rather than delegating them to staff and to report to Congress with detailed explanations.
Who It Affects
The FDA Commissioner, the Senate Committee on Health, Education, Labor, and Pensions, the House Committee on Energy and Commerce, members of Congress, FDA officials involved in opioid drug approval decisions, and companies seeking approval for opioid drugs.
Key Provisions
- Any approval of an opioid drug that goes against an advisory committee's recommendation must be made personally by the FDA Commissioner and cannot be handed off to someone else (Sec. 2(a))
- When the Commissioner approves an opioid drug against the advisory committee's recommendation, the Commissioner must submit a report to Congress that includes medical evidence supporting the decision and discloses any conflicts of interest among FDA officials involved (Sec. 2(b)(1))
- The FDA Commissioner must testify before the Senate or House committees if they request it to explain the decision to approve an opioid drug against the advisory committee's recommendation (Sec. 2(b)(2))
- Approved opioid drugs cannot be marketed or sold across state lines until the required congressional report is submitted (Sec. 2(c))
What Changes
The bill requires the FDA Commissioner to personally handle all opioid drug approvals that contradict advisory committee recommendations instead of delegating these decisions. It also mandates Congressional notification with supporting evidence before such drugs can be marketed.
Important Definitions
- Opioid: a powerful pain medication
- Advisory committee: a group of experts who review and make recommendations about drug safety
- Supplement to an application: a request to modify or add to a previous drug approval request
- Interstate commerce: buying and selling goods across state lines
Effective Date
Not specified in bill text
II
118TH CONGRESS
1ST SESSION
S. 603
To establish procedures regarding the approval of opioid drugs by the Food
and Drug Administration.
IN THE SENATE OF THE UNITED STATES
MARCH 1, 2023
Mr. MANCHIN (for himself, Mr. BRAUN, 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 603 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 Addiction and Recovery Act of 2016 (Pub-
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lic 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 603 IS
prior to the Commissioner’s final decision under
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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-
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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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