```

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5854 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 5854

  To allow the importation, distribution, and sale of investigational 
   drugs and devices intended for use by terminally ill patients who 
                 execute an informed consent document.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           December 11, 2014

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

_______________________________________________________________________

                                 A BILL

 
  To allow the importation, distribution, and sale of investigational 
   drugs and devices intended for use by terminally ill patients who 
                 execute an informed consent document.

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

SECTION 1. 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 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) 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 (42 
        U.S.C. 262), and cannot otherwise be lawfully marketed in the 
        United States; and
            ``(2) is or has been the subject of one or more clinical 
        trials.''.
                                 <all>
```