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S. 1052 (115th): BENEFIT Act of 2017


The text of the bill below is as of Aug 4, 2017 (Referred to House Committee). The bill was not enacted into law.


IC

115th CONGRESS

1st Session

S. 1052

IN THE HOUSE OF REPRESENTATIVES

August 4, 2017

Referred to the Committee on Energy and Commerce

AN ACT

To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs.

1.

Short title

This Act may be cited as the Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2017 or the BENEFIT Act of 2017.

2.

Strengthening the use patient-experience data within benefit-risk framework

Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amended—

(1)

in subsection (a)(1)—

(A)

in subparagraph (A), by striking ; and and inserting a semicolon;

(B)

in subparagraph (B), by striking the period and inserting ; and; and

(C)

by adding at the end the following:

(C)

as part of the risk-benefit assessment framework in the new drug approval process described in section 505(d), considering relevant patient-focused drug development data, such as data from patient preference studies (benefit-risk), patient reported outcome data, or patient experience data, developed by the sponsor of an application or another party.

; and

(2)

in subsection (b)(1). by inserting , including a description of how such data and information were considered in the risk benefit assessment described in section 505(d) before the period.

Passed the Senate August 3, 2017.

Julie E. Adams,

Secretary