BENEFIT Act of 2017

Bill: 115-s-1052
Sponsor: full_name: Sen. Wicker, Roger F. [R-MS]
Introduced: 2017-05-04
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Health information and medical records

Product development and innovation
Latest action: action_date: 2017-08-11
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2017-05-04
action_desc: Introduced in Senate
text: <p><b>Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2017 or the BENEFIT Act of 2017</b></p> This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to consider patient-focused drug development data, such as patient preferences, patient-reported outcomes, and patient experiences, as part of the risk-benefit assessment of new drugs. Following approval of a drug, the FDA must include a description of how this information was considered in its statement of patient experience.

action_date: 2017-08-03
action_desc: Passed Senate without amendment
text: <p>(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)</p> <p><b>Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2017 or the BENEFIT Act of 2017</b></p> (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to consider patient-focused drug development data, such as patient preferences, patient-reported outcomes, and patient experiences, as part of the risk-benefit assessment of new drugs. Following approval of a drug, the FDA must include a description of how this information was considered in its statement of patient experience.

tv_txt: II 115th CONGRESS 1st Session S. 1052 IN THE SENATE OF THE UNITED STATES May 4, 2017 Mr. Wicker (for himself and Ms. Klobuchar ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL 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.

tv_txt: 115th CONGRESS 1st Session S. 1052 IN THE SENATE OF THE UNITED STATES 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. Secretary

tv_txt: 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