21 U.S.C. § 360bbb–8c — Patient participation in medical product discussion

(a) Patient engagement in drugs and devices (1) In general. The Secretary must create ways to ask patients what they think during drug and device development, and consider patient views in regulatory discussions. This includes (A) helping a patient representative — who may serve as a "special government employee" — join agency meetings with drug and device makers and researchers, and (B) trying to find patient representatives who have no, or very little, financial stake in the medical product industry. (2) Protection of proprietary information. This section does not change existing rules protecting confidential business or trade secret information, or other information exempt from disclosure under 5 U.S.C. § 552(b), as those rules applied to consultations before July 9, 2012. (3) Other consultation. This section does not limit the Secretary's power to consult with people and organizations the way the Secretary already could before July 9, 2012. (4) No right or obligation. This section does not give anyone a legal right to a consultation, and does not force the Secretary to meet with any particular expert or stakeholder. It also does not change goals and procedures already agreed to in letters tied to the Prescription Drug User Fee Amendments of 2012, and is not meant to add more review cycles than existed before July 9, 2012. (5) Financial interest. In this section, "financial interest" means the same thing it means under 18 U.S.C. § 208(a), the federal conflict-of-interest law. (b) Statement of patient experience (1) In general. For an application approved under section 355(b) of this title (new drug applications) or section 262(a) of title 42 (biologics), at least 180 days after December 13, 2016, the Secretary must publicly release a brief statement about any patient experience data and related information submitted and reviewed as part of that application. (2) Data and information. That statement covers (A) patient experience data, (B) information on patient-focused drug development tools, and (C) other relevant information the Secretary decides to include. (c) Patient experience data. This term means data that (1) come from anyone — patients, family members, caregivers, patient advocacy organizations, disease research foundations, researchers, or drug manufacturers — and (2) are meant to describe patients' experience with a disease or condition, including (A) the disease's impact — physical and psychosocial — on patients' lives, including impact from a related therapy or clinical investigation, and (B) what patients prefer for treating the disease or condition.