I 

115TH CONGRESS 

1ST SESSION H. R. 1703 

To amend the Federal Food, Drug, and Cosmetic Act with respect to 

determining the intended use of drugs and devices. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 23, 2017 

Mr. GRIFFITH introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to determining the intended use of drugs and devices. 

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 ‘‘Medical Product Com5 munications Act of 2017’’. 


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1 SEC. 2. COMMUNICATIONS REGARDING INTENDED USES OF 

2 DRUGS AND DEVICES; SCIENTIFIC EX3 CHANGE. 

4 The Federal Food, Drug, and Cosmetic Act is amend5 ed by inserting after section 201 of such Act (21 U.S.C. 

6 321) the following: 

7 ‘‘SEC. 201A. INTENDED USES OF DRUGS AND DEVICES. 

8 ‘‘(a) INTENDED USE.—For purposes of this Act, in9 cluding sections 301(d), 502(f)(1), 505, 510, and 515 and 

10 for purposes of section 351 of the Public Health Service 

11 Act, the intended use of a drug, biological product, or de12 vice— 

13 ‘‘(1) shall be determined by reference to the ob14 jective intent of the manufacturer and sponsor of 

15 such drug, biological product, or device, or persons 

16 acting on the manufacturer’s or sponsor’s behalf, as 

17 demonstrated by statements contained in labeling, 

18 advertising, or analogous oral statements; and 

19 ‘‘(2) shall not be determined by reference to— 

20 ‘‘(A) actual or constructive knowledge of 

21 the manufacturer or sponsor that such drug, bi22 ological product, or device will be used in a 

23 manner that varies from the use approved for 

24 marketing under section 505, 510, or 515 of 

25 this Act or section 351 of the Public Health 

26 Service Act; or 


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1 ‘‘(B) scientific exchange as described in 

2 subsection (b). 

3 ‘‘(b) SCIENTIFIC EXCHANGE.— 

4 ‘‘(1) IN GENERAL.—For purposes of this Act, 

5 including sections 301(d), 502(f)(1), 505, 510(k), 

6 and 515 and for purposes of section 351 of the Pub7 lic Health Service Act, the scientific exchange of in8 formation about a drug, biological product, or de9 vice, as described in paragraph (2), shall not con10 stitute labeling, advertising, or evidence of a new in11 tended use. 

12 ‘‘(2) REQUIREMENTS FOR SCIENTIFIC EX13 CHANGE.—A communication by a manufacturer or 

14 sponsor, or a person acting on behalf of a manufac15 turer or sponsor, about the manufacturer’s or spon16 sor’s drug, biological product, or device, or use of 

17 such drug, biological product, or device, that has not 

18 been approved for marketing under section 505, 

19 510, or 515 of this Act or section 351 of the Public 

20 Health Service Act, about a device or use of such de21 vice that has not been approved or cleared for mar22 keting under section 510 or 515 of this Act, or 

23 about information that is not included in the drug, 

24 biological product, or device labeling, constitutes sci25 entific exchange when— 


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1 ‘‘(A) the communication is supported by 

2 scientifically appropriate and statistically sound 

3 data, studies, or analyses; 

4 ‘‘(B) the communication includes a con5 spicuous and prominent statement that the 

6 drug, biological product, or device, or use of 

7 such drug, biological product, or device, that is 

8 the subject of the communication, has not been 

9 approved for marketing under section 505, 510, 

10 or 515 of this Act or section 351 of the Public 

11 Health Service Act, or that such communication 

12 includes information that is not contained in 

13 the drug, biological product, or device labeling, 

14 as applicable; and 

15 ‘‘(C) for communications relating to a 

16 drug, biological product, or device that has not 

17 been approved for marketing under section 505, 

18 510, or 515 of this Act or section 351 of the 

19 Public Health Service Act, or relating to a use 

20 of a drug, biological product, or device that has 

21 not been so approved, the manufacturer and 

22 sponsor make no claims that such product or 

23 use has been demonstrated to be safe or effec24 tive. 


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1 ‘‘(3) SCIENTIFIC EXCHANGE DESCRIBED.—The 

2 scientific exchange of information under paragraph 

3 (2) may include— 

4 ‘‘(A) dissemination of scientific findings in 

5 scientific or lay media; 

6 ‘‘(B) publication of results of scientific 

7 studies; 

8 ‘‘(C) letters to the editor in defense of pub9 lic challenges; 

10 ‘‘(D) communications at scientific or med11 ical conferences or meetings; 

12 ‘‘(E) dissemination of medical or scientific 

13 publications, reference texts, or clinical practice 

14 guidelines; 

15 ‘‘(F) communication, both proactive and 

16 reactive, of information regarding a manufac17 turer’s research and development efforts; 

18 ‘‘(G) communication, both proactive and 

19 reactive, of scientific, medical, or technical in20 formation or findings, including communication 

21 of such information by personnel in scientific, 

22 medical, or clinical development departments of 

23 manufacturers; and 

24 ‘‘(H) communication, both proactive and 

25 reactive, of health care economic and health 


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1 outcomes information, including communication 

2 of such information delivered by or on behalf of 

3 the health care economic or health outcomes de4 partments of manufacturers to an individual, 

5 group of individuals, or entity responsible for 

6 contributing toward, advising, or facilitating de7 cisionmaking related to health care resource or 

8 utilization management, including decisions 

9 about the selection of drugs, biological products, 

10 or devices for a population of patients. 

11 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

12 this subsection shall be construed— 

13 ‘‘(A) to authorize the Secretary to require 

14 that a manufacturer or sponsor submit an ap15 plication, certification, or other such submis16 sion, or to seek the Secretary’s review or ap17 proval, before, during, or subsequent to engag18 ing in scientific exchange; or 

19 ‘‘(B) to limit the ability of manufacturers 

20 or sponsors to engage in communications or ac21 tivities that properly constitute scientific ex22 change as that term is described in paragraph 

23 (2) but that are not specified in paragraph 

24 (3).’’. 

Æ 


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