Compassionate Freedom of Choice Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.
Prohibits the FDA Commissioner from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.
Declares that, except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device shall not be liable in any action under state or federal law for 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 such drugs or devices; or (2) their safety or effectiveness.
[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>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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