United States Code

21 U.S.C. § 360bbb-8c

Patient participation in medical product discussion

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Bills that would change it 29

S 4997 A bill to set forth requirements for the regulation by the Food and Drug Administration of nitrous oxide products, and for other purposes. Amends its part · introduced · 119th Congress
HR 3688 Recall Unsafe Drugs Act of 2023 Amends its part · introduced · 118th Congress
HR 2369 VALID Act of 2023 Amends · introduced · 118th Congress
HR 1092 BENEFIT Act of 2023 Amends · introduced · 118th Congress
S 526 BENEFIT Act of 2023 Amends · introduced · 118th Congress
S 4348 FDASLA Act of 2022 Amends · introduced · 117th Congress
HR 7585 Health Equity and Accountability Act of 2022 Amends · introduced · 117th Congress
S 4486 Health Equity and Accountability Act of 2022 Amends · introduced · 117th Congress
HR 6834 Recall Unsafe Drugs Act of 2022 Amends its part · introduced · 117th Congress
HR 6000 Cures 2.0 Act Amends · introduced · 117th Congress
HR 4472 BENEFIT Act of 2021 Amends · introduced · 117th Congress
HR 4128 VALID Act of 2021 Amends · introduced · 117th Congress
S 2209 VALID Act of 2021 Amends · introduced · 117th Congress
S 1898 Affordable Medications Act Amends its part · introduced · 117th Congress
S 373 BENEFIT Act of 2021 Amends · introduced · 117th Congress
S 3385 BENEFIT Act of 2020 Amends · introduced · 116th Congress
HR 5578 Recall Unsafe Drugs Act of 2020 Amends its part · introduced · 116th Congress
S 1801 Affordable Medications Act Amends its part · introduced · 116th Congress
HR 6 SUPPORT for Patients and Communities Act Amends its part · introduced · 115th Congress
HR 5865 Addiction Prevention and Responsible Opioid Practices Act Amends its part · introduced · 115th Congress
HR 5228 SCREEN Act Amends its part · introduced · 115th Congress
S 2729 Addiction Prevention and Responsible Opioid Practices Act Amends its part · introduced · 115th Congress
HR 5247 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 Amends its part · introduced · 115th Congress
HR 2430 FDA Reauthorization Act of 2017 Amends 360bbb-8c(c)(2)(A) · enacted · 115th Congress
S 1052 BENEFIT Act of 2017 Amends · introduced · 115th Congress
S 934 FDA Reauthorization Act of 2017 Amends 360bbb-8c(c)(2)(A) · introduced · 115th Congress
HR 1776 Improving Access To Affordable Prescription Drugs Act Amends its part · introduced · 115th Congress
S 771 Improving Access To Affordable Prescription Drugs Act Amends its part · introduced · 115th Congress
HR 1108 Recall Unsafe Drugs Act of 2017 Amends its part · introduced · 115th Congress

The law today

From the official United States Code, current through Public Law 119-124.

(a) Patient engagement in drugs and devices (1) In general The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions, including by— (A) fostering participation of a patient representative who may serve as a special government employee in appropriate agency meetings with medical product sponsors and investigators; and (B) exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry. (2) Protection of proprietary information Nothing in this section shall be construed to alter the protections offered by laws, regulations, or policies governing disclosure of confidential commercial or trade secret information and any other information exempt from disclosure pursuant to section 552(b) of title 5 as such laws, regulations, or policies would apply to consultation with individuals and organizations prior to July 9, 2012. (3) Other consultation Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to July 9, 2012. (4) No right or obligation Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the Secretary to meet with any particular expert or stakeholder. Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012. Nothing in this section is intended to increase the number of review cycles as in effect before July 9, 2012. (5) Financial interest In this section, the term “financial interest” means a financial interest under section 208(a) of title 18. (b) Statement of patient experience (1) In general Following the approval of an application that was submitted under section 355(b) of this title or section 262(a) of title 42 at least 180 days after December 13, 2016, the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application. (2) Data and information The data and information referred to in paragraph (1) are— (A) patient experience data; (B) information on patient-focused drug development tools; and (C) other relevant information, as determined by the Secretary. (c) Patient experience data For purposes of this section, the term “patient experience data” includes data that— (1) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and (2) are intended to provide information about patients’ experiences with a disease or condition, including— (A) the impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients’ lives; and (B) patient preferences with respect to treatment of such disease or condition.

Official text at uscode.house.gov ↗