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—
(1)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
(2)exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry.
(b) 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.
(c) 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.
(d) 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.
(e) Financial interest
In this section, the term “financial interest” means a financial interest under section
208(a) of title
Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (d), is section 101(b) ofPub. L. 112–144, which is set out as a note under section
379g of this title.
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.