References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (a)(4), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

Amendments

2017—Subsec. (c)(2)(A). Pub. L. 115–52 substituted "impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation" for "impact of such disease or condition, or a related therapy,".

2016—Subsec. (a). Pub. L. 114–255, §3001(1), (2), substituted "Patient engagement in drugs and devices" for "In general" in subsec. heading, designated existing provisions as par. (1) and inserted par. heading, redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), redesignated subsecs. (b) to (e) as as pars. (2) to (5), respectively, and realigned margins.

Subsecs. (b), (c). Pub. L. 114–255, §3001(3), added subsecs. (b) and (c). Former subsecs. (b) and (c) redesignated pars. (2) and (3), respectively, of subsec. (a).

Subsecs. (d), (e). Pub. L. 114–255, §3001(2), redesignated subsecs. (d) and (e) as pars. (4) and (5), respectively, of subsec. (a).

Patient-Focused Drug Development Guidance

Pub. L. 114–255, div. A, title III, §3002, Dec. 13, 2016, 130 Stat. 1084, provided that:

"(a) Publication of Guidance Documents.—Not later than 180 days after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services (referred to in this section as the 'Secretary'), acting through the Commissioner of Food and Drugs, shall develop a plan to issue draft and final versions of one or more guidance documents, over a period of 5 years, regarding the collection of patient experience data, and the use of such data and related information in drug development. Not later than 18 months after the date of enactment of this Act, the Secretary shall issue a draft version of at least one such guidance document. Not later than 18 months after the public comment period on the draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

"(b) Patient Experience Data.—For purposes of this section, the term 'patient experience data' has the meaning given such term in section 569C of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–8c] (as added by section 3001).

"(c) Contents.—The guidance documents described in subsection (a) shall address—

"(1) methodological approaches that a person seeking to collect patient experience data for submission to, and proposed use by, the Secretary in regulatory decisionmaking may use, that are relevant and objective and ensure that such data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis;

"(2) methodological approaches that may be used to develop and identify what is most important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease;

"(3) approaches to identifying and developing methods to measure impacts to patients that will help facilitate collection of patient experience data in clinical trials;

"(4) methodologies, standards, and technologies to collect and analyze clinical outcome assessments for purposes of regulatory decisionmaking;

"(5) how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the Secretary may submit such proposed draft guidance to the Secretary;

"(6) the format and content required for submissions under this section to the Secretary, including with respect to the information described in paragraph (1);

"(7) how the Secretary intends to respond to submissions of information described in paragraph (1), if applicable, including any timeframe for response when such submission is not part of a regulatory application or other submission that has an associated timeframe for response; and

"(8) how the Secretary, if appropriate, anticipates using relevant patient experience data and related information, including with respect to the structured risk-benefit assessment framework described in section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory decisionmaking."

Streamlining Patient Input

Pub. L. 114–255, div. A, title III, §3003, Dec. 13, 2016, 130 Stat. 1085, provided that: "Chapter 35 of title 44, United States Code, shall not apply to the collection of information to which a response is voluntary, that is initiated by the Secretary under section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended by section 3001) or section 3002 [set out as a note above]."