§ 360bbb–8c. Patient participation in medical product discussion

1,261 words·~6 min read·/usc/title-21/section-360bbb-8c

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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— 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 exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry.

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 . 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 .

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 . In this section, the term “financial interest” means a financial interest under section 208(a) of title 18 .

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. The data and information referred to in paragraph

(1)are— patient experience data; information on patient-focused drug development tools; and other relevant information, as determined by the Secretary. For purposes of this section, the term “patient experience data” includes data that— are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and are intended to provide information about patients’ experiences with a disease or condition, including— the impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients’ lives; and patient preferences with respect to treatment of such disease or condition. ( June 25, 1938, ch. 675, § 569C , as added Pub. L. 112–144, title XI, § 1137 , July 9, 2012 , 126 Stat. 1124 ; amended Pub. L. 114–255, div. A, title III, § 3001 , Dec. 13, 2016 , 130 Stat. 1083 ; Pub. L. 115–52, title VI, § 605 , Aug. 18, 2017 , 131 Stat. 1048 .)

Connections12 cite this · traces to 3

Cited by 12 sections

statute-compilations

Traces to 3 documents

public-private-law

U.S. Code

New drugs
§ 355

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Pub. L. 112-144
126 Stat. 1124
130 Stat. 1083
131 Stat. 1048
130 Stat. 1084
21 USC 360bbb–8c
130 Stat. 1085

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§ 360bbb–8c

Patient participation in medical product discussion

Fed. Reg.×8

Stat. Comp.×4

Pub. L.Public Law 114-255

Pub. L.Public Law 115-52

U.S.C.§ 355

Pub. L.Pub. L. 112-144

Stat.126 Stat. 1124

Stat.130 Stat. 1083

Stat.131 Stat. 1048

Stat.130 Stat. 1084

Cites 10 · showing 8Cited by 12 across 2 sources