I 

113TH CONGRESS 

2D SESSION H. R. 4475 

To allow the manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients 

who execute an informed consent document, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 10, 2014 

Mr. GRIFFITH of Virginia (for himself and Mr. HANNA) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To allow the manufacture, importation, distribution, and sale 

of investigational drugs and devices intended for use 

by terminally ill patients who execute an informed consent document, 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 ‘‘Compassionate Free5 dom of Choice Act of 2014’’. 

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1 SEC. 2. DRUGS AND DEVICES FOR USE BY TERMINALLY ILL 

2 PATIENTS. 

3 The Federal Food, Drug, and Cosmetic Act is amend4 ed by inserting after section 561 (21 U.S.C. 360bbb) the 

5 following: 

6 ‘‘SEC. 561A. DRUGS AND DEVICES FOR USE BY TERMINALLY 

7 ILL PATIENTS. 

8 ‘‘(a) IN GENERAL.—Nothing in this Act or section 

9 351 of the Public Health Service Act prevents or restricts, 

10 and the Food and Drug Administration shall not imple11 ment or enforce any provision of law preventing or re12 stricting, the manufacture, importation, distribution, or 

13 sale of an investigational drug or device intended for use 

14 by a terminally ill patient in accordance with subsection 

15 (b). 

16 ‘‘(b) PATIENT REQUIREMENTS.—In order for an in17 vestigational drug or device to be intended for use in ac18 cordance with this subsection, such drug or device must 

19 be intended for use by a patient who has— 

20 ‘‘(1) been diagnosed with a terminal illness by 

21 a licensed physician; 

22 ‘‘(2) been informed by a licensed physician that 

23 no drug or device that is lawfully marketed in the 

24 United States is likely to cure the illness; and 

25 ‘‘(3) executed a written informed consent docu26 ment that states— 

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1 ‘‘(A) the known and potential risks and 

2 benefits of such drug or device; and 

3 ‘‘(B) any indications of the illness for 

4 which a drug or device is lawfully marketed, or 

5 for which treatment is otherwise available, in 

6 the United States. 

7 ‘‘(c) PROHIBITION ON REQUIRING THE DISCLOSURE, 

8 COLLECTION, AND REPORTING OF CERTAIN INFORMA9 TION BY FOOD AND DRUG ADMINISTRATION.— 

10 ‘‘(1) IN GENERAL.—The Commissioner of Food 

11 and Drugs may not require the disclosure, collection, 

12 or reporting of— 

13 ‘‘(A) any information related to the deliv14 ery, administration, or use of an investigational 

15 drug or device pursuant to this section; or 

16 ‘‘(B) any information related to the clinical 

17 outcomes experienced by a terminally ill patient 

18 supplied an investigational drug or device pur19 suant to this section. 

20 ‘‘(2) EXCEPTION.—Nothing in this subsection 

21 prevents the sponsor of a clinical trial from volun22 tarily disclosing, collecting, or reporting information 

23 to the Food and Drug Administration. 

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1 ‘‘(d) DEFINITION OF INVESTIGATIONAL DRUG OR

2 DEVICE.—In this section, the term ‘investigational drug 

3 or device’ means a drug or device that— 

4 ‘‘(1) has not yet been approved, licensed, or 

5 cleared for commercial distribution under section 

6 505, 510(k), or 515 of this Act or section 351 of the 

7 Public Health Service Act, and cannot otherwise be 

8 lawfully marketed in the United States; and 

9 ‘‘(2) is or has been the subject of one or more 

10 clinical trials.’’. 

11 SEC. 3. LIABILITY PROTECTION. 

12 The Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 301 et seq.) is amended by inserting after section 

14 561A, as inserted by section 2 of this Act, the following: 

15 ‘‘SEC. 561B. LIABILITY PROTECTION. 

16 ‘‘Except in the case of gross negligence or willful mis17 conduct, any person who manufactures, imports, distrib18 utes, prescribes, dispenses, or administers an investiga19 tional drug or device in accordance with section 561A shall 

20 not be liable in any action under Federal or State law for 

21 any loss, damage, or injury arising out of, relating to, or 

22 resulting from— 

23 ‘‘(1) the design, development, clinical testing 

24 and investigation, manufacturing, labeling, distribumstockstill on DSK4VPTVN1PROD with BILLS

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1 tion, sale, purchase, donation, dispensing, prescrip2 tion, administration, or use of the drug or device; or 

3 ‘‘(2) the safety or effectiveness of the drug or 

4 device.’’. 

Æ 

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