I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Pre-approval Informa5 tion Exchange Act of 2022’’. 


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1 SEC. 2. FACILITATING EXCHANGE OF INFORMATION PRIOR 

2 TO APPROVAL. 

3 Section 502(a) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 352(a)) is amended— 

5 (1) by redesignating subparagraph (2) as sub6 paragraph (3); 

7 (2) by inserting after subparagraph (1) the fol8 lowing: 

9 ‘‘(2)(A) Health care economic information, scientific 

10 information, or product support information provided to 

11 a covered payor responsible for the selection of drugs or 

12 devices for coverage, reimbursement, or other population13 based health care management, shall not be considered 

14 false or misleading or any other form of misbranding 

15 under this section or a violation of section 505, 510(k), 

16 513, or 515 of this Act or section 351 of the Public Health 

17 Service Act, or otherwise prohibited pre-approval pro18 motion of a drug or device, if it— 

19 ‘‘(i)(I) in the case of health care economic in20 formation, is based on competent and reliable sci21 entific evidence; or 

22 ‘‘(II) in the case of scientific information other 

23 than health care economic information, is truthful 

24 and nonmisleading; and 

25 ‘‘(ii) relates to an investigational drug or device 

26 or investigational use of a drug or device that is apVerDate Sep 11 2014 03:54 Mar 11, 2022 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7008.IH H7008

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1 proved, cleared, or licensed under section 505, 

2 510(k), 513, or 515 of this Act or section 351 of the 

3 Public Health Service Act (as applicable). 

4 ‘‘(B) In order to provide information pursuant to this 

5 subparagraph relating to an investigational drug or device, 

6 or an investigational use of an drug or device that has 

7 been approved, granted marketing authorization, cleared, 

8 or licensed— 

9 ‘‘(i) the information must include— 

10 ‘‘(I) a clear statement that the investiga11 tional drug or device or investigational use of a 

12 drug or device has not been approved, cleared, 

13 or licensed under section 505, 510(k), 513, or 

14 515 of this Act or section 351 of the Public 

15 Health Service Act (as applicable) and that the 

16 safety and effectiveness of the drug or device or 

17 use has not yet been established; 

18 ‘‘(II) information related to the stage of 

19 development of the drug or device involved, 

20 such as— 

21 ‘‘(aa) the status of any study or stud22 ies in which the investigational drug or de23 vice or investigational use is being inves24 tigated; 


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1 ‘‘(bb) how the study or studies relate 

2 to the overall plan for the development of 

3 the drug or device; 

4 ‘‘(cc) whether a marketing application 

5 or notification for the investigational drug 

6 or device or investigational use has been 

7 submitted to the Secretary and when such 

8 a submission is planned; 

9 ‘‘(III) in the case of communications that 

10 include factual presentations of results from 

11 studies, a description of— 

12 ‘‘(aa) material aspects of study de13 sign, methodology, and results; and 

14 ‘‘(bb) material limitations related to 

15 the study design, methodology, and results; 

16 and 

17 ‘‘(IV) where applicable, a conspicuous and 

18 prominent statement describing any material 

19 differences between the information provided 

20 and the labeling approved, granted marketing 

21 authorization, cleared, or licensed pursuant to 

22 section 505, 510(k), 513, or 515 of this Act or 

23 section 351 of the Public Health Service Act. 

24 ‘‘(C) For purposes of this subparagraph— 


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1 ‘‘(i) the term ‘covered payor’ means a payor, 

2 formulary committee, drug information center, tech3 nology assessment committee, pharmacy benefit 

4 manager, and other multidisciplinary entity that, on 

5 behalf of health care organizations, reviews scientific 

6 or technology assessments, or other similar entity 

7 with knowledge and expertise to evaluate health care 

8 economic analysis or scientific information on a pop9 ulation basis; 

10 ‘‘(ii) the term ‘product support information’ in11 cludes— 

12 ‘‘(I) information describing the drug or de13 vice (such as drug class, device description, and 

14 features); 

15 ‘‘(II) information about the indication or 

16 indications sought; 

17 ‘‘(III) the anticipated timeline for a pos18 sible approval, clearance, or licensure pursuant 

19 to section 505, 510(k), 513, or 515 of this Act 

20 or section 351 of the Public Health Service Act; 

21 ‘‘(IV) drug or device pricing information; 

22 ‘‘(V) patient utilization projections; and 

23 ‘‘(VI) product-related programs or services. 

24 ‘‘(iii) the term ‘scientific information’ includes 

25 clinical and pre-clinical data and results relating to 


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1 a drug or device or use that has not been approved, 

2 granted marketing authorization, cleared, or licensed 

3 and is being investigated or developed.’’; 

4 (3) in subparagraph (3), as redesignated— 

5 (A) by striking ‘‘(A)’’; 

6 (B) by striking clause (B); and 

7 (C) by striking ‘‘drug’’ each place it ap8 pears and inserting ‘‘drug or device’’; and 

9 (4) by adding at the end the following: 

10 ‘‘(4) Nothing in this section shall be construed to 

11 limit the ability of manufacturers or sponsors of drugs or 

12 devices to engage in communications or activities not spec13 ified in subparagraph (2) or (3) that are otherwise permis14 sible.’’. 

15 SEC. 3. GAO STUDY AND REPORT. 

16 Beginning on the date that is 5 years and 6 months 

17 after the date of enactment of this Act, the Comptroller 

18 General of the United States (in this subsection referred 

19 to as the ‘‘Comptroller General’’) shall conduct a study 

20 on the provision and use of information pursuant to sec21 tion 502(a)(2) of the Federal Food, Drug, and Cosmetic 

22 Act, as added by section 2 of this Act, between manufac23 turers of, and covered entities (as defined in such section 

24 502(a)(2)) for, drugs and devices (as defined in section 

25 201 of the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 321)). Such study shall include an analysis of the 

2 following: 

3 (1) The type of information communicated be4 tween such manufacturers and payors. 

5 (2) The manner of communication between 

6 such manufacturers and payors. 

7 (3)(A) Whether such manufacturers file a sub8 mission for approval, marketing authorization, clear9 ance, or licensing of a new drug or device or the new 

10 use of a drug or device that is the subject of commu11 nication between such manufacturers and payors be12 fore the new use is approved, granted marketing au13 thorization, cleared, or licensed. 

14 (B) How frequently the Food and Drug Admin15 istration approves, grants marketing authorization, 

16 clears, or licenses the new drug or device or new use. 

17 (C) The timeframe between the initial commu18 nications under section 502(a) of the Federal Food, 

19 Drug, and Cosmetic Act, as amended by this Act, 

20 regarding an investigational drug or device or inves21 tigational use, and the initial marketing of such 

22 drug or device or investigational use. 

Æ 


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