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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4475 Introduced in House (IH)]

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.

    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 ``Compassionate Freedom of Choice Act 
of 2014''.

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

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

``SEC. 561A. DRUGS AND DEVICES FOR USE BY TERMINALLY ILL PATIENTS.

    ``(a) In General.--Nothing in this Act or section 351 of the Public 
Health Service Act prevents or restricts, and the Food and Drug 
Administration shall not implement or enforce any provision of law 
preventing or restricting, the manufacture, importation, distribution, 
or sale of an investigational drug or device intended for use by a 
terminally ill patient in accordance with subsection (b).
    ``(b) Patient Requirements.--In order for an investigational drug 
or device to be intended for use in accordance with this subsection, 
such drug or device must be intended for use by a patient who has--
            ``(1) been diagnosed with a terminal illness by a licensed 
        physician;
            ``(2) been informed by a licensed physician that no drug or 
        device that is lawfully marketed in the United States is likely 
        to cure the illness; and
            ``(3) executed a written informed consent document that 
        states--
                    ``(A) the known and potential risks and benefits of 
                such drug or device; and
                    ``(B) any indications of the illness for which a 
                drug or device is lawfully marketed, or for which 
                treatment is otherwise available, in the United States.
    ``(c) Prohibition on Requiring the Disclosure, Collection, and 
Reporting of Certain Information by Food and Drug Administration.--
            ``(1) In general.--The Commissioner of Food and Drugs may 
        not require the disclosure, collection, or reporting of--
                    ``(A) any information related to the delivery, 
                administration, or use of an investigational drug or 
                device pursuant to this section; or
                    ``(B) any information related to the clinical 
                outcomes experienced by a terminally ill patient 
                supplied an investigational drug or device pursuant to 
                this section.
            ``(2) Exception.--Nothing in this subsection prevents the 
        sponsor of a clinical trial from voluntarily disclosing, 
        collecting, or reporting information to the Food and Drug 
        Administration.
    ``(d) Definition of Investigational Drug or Device.--In this 
section, the term `investigational drug or device' means a drug or 
device that--
            ``(1) has not yet been approved, licensed, or cleared for 
        commercial distribution under section 505, 510(k), or 515 of 
        this Act or section 351 of the Public Health Service Act, and 
        cannot otherwise be lawfully marketed in the United States; and
            ``(2) is or has been the subject of one or more clinical 
        trials.''.

SEC. 3. LIABILITY PROTECTION.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended by inserting after section 561A, as inserted by section 2 of 
this Act, the following:

``SEC. 561B. LIABILITY PROTECTION.

    ``Except in the case of gross negligence or willful misconduct, any 
person who manufactures, imports, distributes, prescribes, dispenses, 
or administers an investigational drug or device in accordance with 
section 561A shall not be liable in any action under Federal or State 
law for any loss, damage, or injury arising out of, relating to, or 
resulting from--
            ``(1) the design, development, clinical testing and 
        investigation, manufacturing, labeling, distribution, sale, 
        purchase, donation, dispensing, prescription, administration, 
        or use of the drug or device; or
            ``(2) the safety or effectiveness of the drug or device.''.
                                 <all>
```