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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7008 Introduced in House (IH)]

<DOC>

117th CONGRESS
  2d Session
                                H. R. 7008

     To improve patient access to emerging medication therapies by 
 clarifying the scope of permitted health care economic and scientific 
information communications between biopharmaceutical manufacturers and 
       population health decision makers, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 9, 2022

 Mr. Guthrie introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
     To improve patient access to emerging medication therapies by 
 clarifying the scope of permitted health care economic and scientific 
information communications between biopharmaceutical manufacturers and 
       population health decision makers, 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 INFORMATION PRIOR TO APPROVAL.

    Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(a)) is amended--
            (1) by redesignating subparagraph (2) as subparagraph (3);
            (2) by inserting after subparagraph (1) the following:
    ``(2)(A) Health care economic information, scientific information, 
or product support information provided to a covered payor responsible 
for the selection of drugs or devices for coverage, reimbursement, or 
other population-based health care management, shall not be considered 
false or misleading or any other form of misbranding under this section 
or a violation of section 505, 510(k), 513, or 515 of this Act or 
section 351 of the Public Health Service Act, or otherwise prohibited 
pre-approval promotion of a drug or device, if it--
            ``(i)(I) in the case of health care economic information, 
        is based on competent and reliable scientific evidence; or
            ``(II) in the case of scientific information other than 
        health care economic information, is truthful and 
        nonmisleading; and
            ``(ii) relates to an investigational drug or device or 
        investigational use of a drug or device that is approved, 
        cleared, or licensed under section 505, 510(k), 513, or 515 of 
        this Act or section 351 of the Public Health Service Act (as 
        applicable).
    ``(B) In order to provide information pursuant to this subparagraph 
relating to an investigational drug or device, or an investigational 
use of an drug or device that has been approved, granted marketing 
authorization, cleared, or licensed--
            ``(i) the information must include--
                    ``(I) a clear statement that the investigational 
                drug or device or investigational use of a drug or 
                device has not been approved, cleared, or licensed 
                under section 505, 510(k), 513, 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 yet been established;
                    ``(II) information related to the stage of 
                development of the drug or device involved, such as--
                            ``(aa) the status of any study or studies 
                        in which the investigational drug or device or 
                        investigational use is being investigated;
                            ``(bb) how the study or studies relate to 
                        the overall plan for the development of the 
                        drug or device;
                            ``(cc) whether a marketing application or 
                        notification 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 communications that include 
                factual presentations of results from studies, a 
                description of--
                            ``(aa) material aspects of study design, 
                        methodology, and results; and
                            ``(bb) material limitations related to the 
                        study design, methodology, and results; and
                    ``(IV) where applicable, a conspicuous and 
                prominent statement describing any material differences 
                between the information provided and the labeling 
                approved, granted marketing authorization, cleared, or 
                licensed pursuant to section 505, 510(k), 513, or 515 
                of this Act or section 351 of the Public Health Service 
                Act.
    ``(C) For purposes of this subparagraph--
            ``(i) the term `covered payor' means a payor, formulary 
        committee, drug information center, technology assessment 
        committee, pharmacy benefit manager, and other 
        multidisciplinary entity that, on behalf of health care 
        organizations, reviews scientific or technology assessments, or 
        other similar entity with knowledge and expertise to evaluate 
        health care economic analysis or scientific information on a 
        population basis;
            ``(ii) the term `product support information' includes--
                    ``(I) information describing the drug or device 
                (such as drug class, device description, and features);
                    ``(II) information about the indication or 
                indications sought;
                    ``(III) the anticipated timeline for a possible 
                approval, clearance, or licensure pursuant to section 
                505, 510(k), 513, or 515 of this Act or section 351 of 
                the Public Health Service Act;
                    ``(IV) drug or device pricing information;
                    ``(V) patient utilization projections; and
                    ``(VI) product-related programs or services.
            ``(iii) the term `scientific information' includes clinical 
        and pre-clinical data and results relating to a drug or device 
        or use that has not been approved, granted marketing 
        authorization, cleared, or licensed and is being investigated 
        or developed.'';
            (3) in subparagraph (3), as redesignated--
                    (A) by striking ``(A)'';
                    (B) by striking clause (B); and
                    (C) by striking ``drug'' each place it appears and 
                inserting ``drug or device''; and
            (4) by adding at the end the following:
    ``(4) Nothing in this section shall be construed to limit the 
ability of manufacturers or sponsors of drugs or devices to engage in 
communications or activities not specified in subparagraph (2) or (3) 
that are otherwise permissible.''.

SEC. 3. 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 
(in this subsection referred to as the ``Comptroller General'') shall 
conduct a study on the provision and use of information pursuant to 
section 502(a)(2) of the Federal Food, Drug, and Cosmetic Act, as added 
by section 2 of this Act, between manufacturers of, and covered 
entities (as defined in such section 502(a)(2)) for, drugs and devices 
(as defined in section 201 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321)). Such study shall include an analysis of the 
following:
            (1) The type of information communicated between such 
        manufacturers and payors.
            (2) The manner of communication between such manufacturers 
        and payors.
            (3)(A) Whether such manufacturers file a submission 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 before the new use is approved, granted marketing 
        authorization, cleared, or licensed.
            (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 under 
        section 502(a) of the Federal Food, Drug, and Cosmetic Act, as 
        amended by this Act, regarding an investigational drug or 
        device or investigational use, and the initial marketing of 
        such drug or device or investigational use.
                                 <all>
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