Pre-Approval Information Exchange Act of 2022
Bill: H.R.9297 | Sponsor: Rep. Guthrie, Brett (R-KY)
Policy area: Health

Summary:
Pre-Approval Information Exchange Act of 2022
This bill specifies that product information that is exchanged between drug manufacturers and certain health care entities (e.g., formulary committees) about drug products before regulatory approval is not considered to be misbranding if it relates to the product's investigational use and meets other specified criteria. The Government Accountability Office must study the use and effects of such information.

To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
    exchange of certain product information, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pre-Approval Information Exchange 
Act of 2022''.

SEC. 2. FACILITATING EXCHANGE OF PRODUCT INFORMATION PRIOR TO APPROVAL.

    (a) In General.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended--
            (1) in paragraph (a)--
                    (A) by striking ``drugs for coverage'' and 
                inserting ``drugs or devices for coverage''; and
                    (B) by striking ``drug'' each place it appears and 
                inserting ``drug or device'', respectively;
            (2) in paragraphs (a)(1) and (a)(2)(B), by striking ``under 
        section 505 or under section 351 of the Public Health Service 
        Act'' and inserting ``under section 505, 510(k), 513(f)(2), or 
        515 of this Act or section 351 of the Public Health Service 
        Act'';
            (3) in paragraph (a)(1)--
                    (A) by striking ``under section 505 or under 
                section 351(a) of the Public Health Service Act'' and 
                inserting ``under section 505, 510(k), 513(f)(2), or 
                515 of this Act or section 351 of the Public Health 
                Service Act''; and
                    (B) by striking ``in section 505(a) or in 
                subsections (a) and (k) of section 351 of the Public 
                Health Service Act'' and inserting ``in section 505, 
                510(k), 513(f)(2), or 515 of this Act or section 351 of 
                the Public Health Service Act''; and
            (4) by adding at the end the following:
    ``(gg)(1) Unless its labeling bears adequate directions for use in 
accordance with paragraph (f), except that (in addition to drugs or 
devices that conform with exemptions pursuant to such paragraph) no 
drug or device shall be deemed to be misbranded under such paragraph 
through the provision of product information to a payor, formulary 
committee, or other similar entity with knowledge and expertise in the 
area of health care economic analysis carrying out its responsibilities 
for the selection of drugs or devices for coverage or reimbursement if 
the product information relates to an investigational drug or device or 
investigational use of a drug or device that is approved, cleared, 
granted marketing authorization, or licensed under section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of the Public Health 
Service Act (as applicable), provided--
            ``(A) the product information includes--
                    ``(i) a clear statement that the investigational 
                drug or device or investigational use of a drug or 
                device has not been approved, cleared, granted 
                marketing authorization, or licensed under section 505, 
                510(k), 513(f)(2), or 515 of this Act or section 351 of 
                the Public Health Service Act (as applicable) and that 
                the safety and effectiveness of the drug or device or 
                use has not been established;
                    ``(ii) information related to the stage of 
                development of the drug or device involved, such as--
                            ``(I) the status of any study or studies in 
                        which the investigational drug or device or 
                        investigational use is being investigated;
                            ``(II) how the study or studies relate to 
                        the overall plan for the development of the 
                        drug or device; and
                            ``(III) whether an application, premarket 
                        notification, or request for classification for 
                        the investigational drug or device or 
                        investigational use has been submitted to the 
                        Secretary and when such a submission is 
                        planned;
                    ``(iii) in the case of information that includes 
                factual presentations of results from studies, which 
                shall not be selectively presented, a description of--
                            ``(I) all material aspects of study design, 
                        methodology, and results; and
                            ``(II) all material limitations related to 
                        the study design, methodology, and results;
                    ``(iv) where applicable, a prominent statement 
                disclosing the indication or indications for which the 
                Secretary has approved, granted marketing 
                authorization, cleared, or licensed the product 
                pursuant to section 505, 510(k), 513(f)(2), or 515 of 
                this Act or section 351 of the Public Health Service 
                Act, and a copy of the most current required labeling; 
                and
                    ``(v) updated information, if previously 
                communicated information becomes materially outdated as 
                a result of significant changes or as a result of new 
                information regarding the product or its review status; 
                and
            ``(B) the product information does not include--
                    ``(i) information that represents that an 
                unapproved product--
                            ``(I) has been approved, cleared, granted 
                        marketing authorization, or licensed under 
                        section 505, 510(k), 513(f)(2), or 515 of this 
                        Act or section 351 of the Public Health Service 
                        Act (as applicable); or
                            ``(II) has otherwise been determined to be 
                        safe or effective for the purpose or purposes 
                        for which the drug or device is being studied; 
                        or
                    ``(ii) information that represents that an 
                unapproved use of a drug or device that has been so 
                approved, granted marketing authorization, cleared, or 
                licensed--
                            ``(I) is so approved, granted marketing 
                        authorization, cleared, or licensed; or
                            ``(II) that the product is safe or 
                        effective for the use or uses for which the 
                        drug or device is being studied.
    ``(2) For purposes of this paragraph, the term `product 
information' includes--
            ``(A) information describing the drug or device (such as 
        drug class, device description, and features);
            ``(B) information about the indication or indications being 
        investigated;
            ``(C) the anticipated timeline for a possible approval, 
        clearance, marketing authorization, or licensure pursuant to 
        section 505, 510(k), 513, or 515 of this Act or section 351 of 
        the Public Health Service Act;
            ``(D) drug or device pricing information;
            ``(E) patient utilization projections;
            ``(F) product-related programs or services; and
            ``(G) factual presentations of results from studies that do 
        not characterize or make conclusions regarding safety or 
        efficacy.''.
    (b) GAO Study and Report.--Beginning on the date that is 5 years 
and 6 months after the date of enactment of this Act, the Comptroller 
General of the United States shall conduct a study on the provision and 
use of information pursuant to section 502(gg) of the Federal Food, 
Drug, and Cosmetic Act, as added by this subsection (a), between 
manufacturers of drugs and devices (as defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities 
described in such section 502(gg). Such study shall include an analysis 
of the following:
            (1) The types of information communicated between such 
        manufacturers and payors.
            (2) The manner of communication between such manufacturers 
        and payors.
            (3)(A) Whether such manufacturers file an application for 
        approval, marketing authorization, clearance, or licensing of a 
        new drug or device or the new use of a drug or device that is 
        the subject of communication between such manufacturers and 
        payors under section 502(gg) of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a).
            (B) How frequently the Food and Drug Administration 
        approves, grants marketing authorization, clears, or licenses 
        the new drug or device or new use.
            (C) The timeframe between the initial communications 
        permitted under section 502(gg) of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a), regarding an 
        investigational drug or device or investigational use, and the 
        initial marketing of such drug or device.
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