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II
116TH CONGRESS
2D SESSION
S. 3385
To strengthen the use of patient-experience data within the benefit-risk
framework for approval of new drugs.
IN THE SENATE OF THE UNITED STATES
MARCH 4, 2020
Mr. WICKER (for himself and Ms. KLOBUCHAR) introduced the following bill;
which was read twice and referred to the Committee on Health, Edu-
cation, Labor, and Pensions
A BILL
To strengthen the use of patient-experience data within the
benefit-risk framework for approval of new drugs.
Be it enacted by the Senate and House of Representa-
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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 ‘‘Better Empowerment
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Now to Enhance Framework and Improve Treatments Act
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of 2020’’ or the ‘‘BENEFIT Act of 2020’’.
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•S 3385 IS
SEC. 2. STRENGTHENING THE USE OF PATIENT-EXPERI-
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ENCE DATA WITHIN BENEFIT-RISK FRAME-
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WORK.
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Section 569C of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 360bbb–8c) is amended—
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(1) in subsection (a)(1)—
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(A) in subparagraph (A), by striking ‘‘;
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and’’ and inserting a semicolon;
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(B) in subparagraph (B), by striking the
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period and inserting ‘‘; and’’; and
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(C) by adding at the end the following:
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‘‘(C) as part of the risk-benefit assessment
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framework in the new drug approval process de-
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scribed in section 505(d), considering relevant
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patient-focused drug development data, such as
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data from patient preference studies (benefit-
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risk), patient reported outcome data, or patient
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experience data, developed by the sponsor of an
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application or another party.’’; and
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(2) in subsection (b)(1), by inserting ‘‘, includ-
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ing a description of how such data and information
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were considered in the risk benefit assessment de-
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scribed in section 505(d)’’ before the period.
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Æ
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