I
107TH CONGRESS
1ST SESSION
H. R. 1964
To allow patients access to drugs and medical devices recommended and
provided by health care practitioners under strict guidelines, and for
other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 23, 2001
Mr. DEFAZIO (for himself, Mr. BARTON of Texas, Mr. BURR of North Caro-
lina, Mr. EVANS, Mr. FRANK, Mr. PAUL, Mr. ROYCE, Mr. SANDERS, and
Mr. WYNN) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce
A BILL
To allow patients access to drugs and medical devices rec-
ommended and provided by health care practitioners
under strict guidelines, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Access to Medical
Treatment Act of 2001’’.
SEC. 2. DEFINITIONS.
In this Act:
(1) ADULTERATED.—The term ‘‘adulterated’’
means any unapproved drug or medical device that
in whole or part consists of any filthy, putrid, or de-
composed substance that has been prepared, packed,
or held under unsanitary conditions where such drug
or device may have been contaminated with such
filthy, putrid, or decomposed substance and be inju-
rious to health.
(2) ADVERTISING
CLAIM.—The term ‘‘adver-
tising claim’’ means any representation made or sug-
gested by statement, word, device, sound, or any
combination thereof with respect to medical treat-
ment.
(3) COSTS.—The term ‘‘costs’’ means a charge
to patients equal to the amount necessary to recover
expenses for making or obtaining the unapproved
drug or medical device and providing for its trans-
port to the health care practitioner. Such term does
not include the fees charged by a health care practi-
tioner for his or her professional services in admin-
istering, providing, or counseling the patient con-
cerning the unapproved drug or medical device.
(4) DANGER.—The term ‘‘danger’’ means an
adverse reaction, to an unapproved drug or medical
device, that used as directed—
(A) causes serious harm to the patient in
a case in which such harm would not have oth-
erwise occurred; or
(B) causes harm that is more serious than
side effects for drugs or medical devices ap-
proved by the Federal Food and Drug Adminis-
tration for the same disease or condition.
(5) DRUG.—The term ‘‘drug’’ has the same
meaning given that term in section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(g)(1)).
(6) HEALTH CARE PRACTITIONER.—The term
‘‘health care practitioner’’ means a physician or
other individual who is a provider of health care,
who is authorized under the law of a State to pre-
scribe drugs or devices.
(7) INTERSTATE COMMERCE.—The term ‘‘inter-
state commerce’’ means commerce between any
State or Territory and any place outside thereof,
and commerce within the District of Columbia or
within any other Territory not organized with a leg-
islative body.
(8) LEGAL REPRESENTATIVE.—The term ‘‘legal
representative’’ means a parent or other person who
qualifies as a legal guardian under State law.
(9) MEDICAL DEVICE.—The term ‘‘medical de-
vice’’ has the same meaning given the term ‘‘device’’
in section 201(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(h)).
(10) PATIENT.—The term ‘‘patient’’ means any
person who seeks medical treatment from a health
care practitioner for a disease or health condition.
(11) 
SECRETARY.—The 
term 
‘‘Secretary’’
means the Secretary of the Department of Health
and Human Services.
(12) UNAPPROVED
DRUG
OR
MEDICAL
DE-
VICE.—The term ‘‘unapproved’’, with respect to a
drug or medical device, means a drug or medical de-
vice that is not approved or authorized for manufac-
ture, sale, and distribution in interstate commerce
under section 505, 513, or 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355, 360c, and
360e) or under section 351 of the Public Health
Service Act (42 U.S.C. 201).
SEC. 3. ACCESS TO MEDICAL TREATMENT.
(a) 
IN
GENERAL.—Notwithstanding 
sections
501(a)(2)(B), 501(e) through 501(h), 502(f)(1), 505,
513, and 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351(a)(2)(B), 351(e) through 351(h),
352(f)(1), 355, 360c, and 360e) and section 351 of the
Public Health Service Act (42 U.S.C. 201) or any other
provision of Federal law, a patient may receive, and a
health care practitioner may provide or administer, any
unapproved drug or medical device that the patient desires
or the legal representative of the patient authorizes if—
(1) such practitioner has personally examined
such patient and agrees to treat such patient;
(2) the unapproved drug or medical device is
recommended by a health care practitioner within
that practitioner’s scope of practice under State law;
(3) the provision or administration of the unap-
proved drug or medical device is not a violation of
the laws of the State or States in which the activity
is carried out; and
(4) the health care practitioner abides by all of
the requirements in subsection (b).
(b) REQUIREMENTS.—A health care practitioner may
recommend, provide or administer any unapproved drug
or medical device for a patient, pursuant to subsection (a),
if that practitioner—
(1) does not violate State law by providing or
administering the unapproved drug or medical de-
vice;
(2) does not violate the Controlled Substances
Act (21 U.S.C. 801 et seq.) by providing or admin-
istering the unapproved drugs;
(3) has concluded based on generally accepted
principles and current information that the unap-
proved drug or medical device, when used as di-
rected, will not cause a danger to the patient;
(4) provides the recommendation under cir-
cumstances that give the patient sufficient oppor-
tunity to consider whether or not to use such a drug
or medical device and that minimize the possibility
of coercion or undue influence by the health care
practitioner;
(5) discloses to the patient any financial inter-
est that such a practitioner may have in the drug or
medical device;
(6) has informed the patient in writing, prior to
recommending, providing, or administering the un-
approved drug or medical device—
(A) that the unapproved drug or medical
device is not approved by the Secretary as safe
and effective for the condition of the patient
and is considered experimental;
(B) of the foreseeable risks and benefits of
the unapproved drug or medical device, includ-
ing any risk to an embryo or fetus, and ex-
pected possible side effects or discomforts that
the patient may experience and any medical
treatment available if side affects occur;
(C) of any appropriate alternative proce-
dures or courses of treatment (including proce-
dures or courses of treatment that may involve
the use of a drug or medical device that has
been approved by the Food and Drug Adminis-
tration), if any, that may be advantageous for
the patient’s condition;
(D) of any interactions the unapproved
drug or medical device may have with other
drugs, if any;
(E) of the active and inactive ingredients
of the unapproved drug and the mechanism of
action of the medical device, if known;
(F) of the health condition for which the
unapproved drug or medical device is provided,
the method of administration that will be used,
and the unit dose;
(G) of the procedures that will be employed
by the health care practitioner in using such a
drug or medical device;
(H) of the extent, if any, to which con-
fidentiality of records identifying the patient
will be maintained;
(I) for use of such a drug or medical de-
vice involving more than minimal risk, of the
treatments available if injury occurs, what such
treatments involve, and where additional infor-
mation regarding such treatments may be ob-
tained;
(J) of any anticipated circumstances under
which the patient’s use of such a drug or med-
ical device may be terminated by the health
care practitioner without regard to the patient’s
consent;
(K) that the use of an such a drug or med-
ical device is voluntary and that the patient
may suspend or terminate treatment at any
time;
(L) of the consequences of a patient’s deci-
sion to withdraw from the use of such a drug
or medical device;
(M) if any information described in sub-
paragraphs (A) through (L) cannot be provided
by the health care practitioner because such in-
formation is not known at the time the practi-
tioner provides or administers such drug or
medical device, that such information cannot be
provided by the practitioner; and
(N) of any other information or disclosures
required by applicable State law for the admin-
istration of experimental drugs or medical de-
vices to human subjects;
(7) has not made, except as provided in sub-
section (d), any advertising claims for the unap-
proved drug or medical device;
(8) does not impose a charge for the unap-
proved drug or medical device in excess of costs;
(9) complies with requirements for reporting a
danger in section 4; and
(10) has received a signed affidavit from the
patient or the patient’s legal representative con-
firming that the patient or the legal representative—
(A) has received the written information
required by this subsection and understands it;
and
(B) desires treatment with the unapproved
drug or medical device as recommended by the
health care practitioner.
The provisions of paragraph (8) shall not be construed to
apply to dietary supplements.
(c) MANDATORY DISCLOSURE.—Any manufacturer of
an unapproved drug or medical device shall disclose, to
any health care practitioner that has received such drug
or medical device from such manufacturer, all information
available to such manufacturer regarding such drug or
medical device to enable such practitioner to comply with
the requirements of subsection (b)(3) and make a deter-
mination regarding the danger posed by such drug or med-
ical device. Compliance with this subsection shall not con-
stitute a violation of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.).
(d) ADVERTISING CLAIMS EXCEPTION.—Subsection
(b)(7) shall not apply to a health care practitioner’s dis-
semination of information on the results of the practi-
tioner’s administration of the unapproved drug or medical
device in a peer-reviewed journal, through academic or
professional forums, or through statements by a practi-
tioner to a patient. Subsection (b)(7) shall not apply to
any accurate and truthful statement made in person by
a health care practitioner to an individual or a prospective
patient.
SEC. 4. CESSATION OF USE, AND REPORTING OF, DAN-
GEROUS DRUGS AND MEDICAL DEVICES.
(a) DUTY TO PROTECT PATIENT.—If a health care
practitioner discovers that an unapproved drug or medical
(7) an affidavit pursuant to section 1746 of
title 28, United States Code, confirming that all
statements made to the manufacturer are accurate.
(b) MANUFACTURER’S
DUTY
TO
REPORT.—Any
manufacturer of an unapproved drug or medical device
that receives information provided under subsection (a)
shall immediately—
(1) cease sale and distribution of the unap-
proved drug or medical device pending completion of
an investigation to determine the actual cause of the
danger;
(2) notify all health care practitioners to whom
the manufacturer has provided the unapproved drug
or medical device of the information provided to the
manufacturer under subsection (a); and
(3) report to the Secretary in writing that an
unapproved drug or medical device (identified by
name, known method of operation, unit dose, and in-
tended use) that the manufacturer provided to a
health care practitioner for administration under
this Act has been reported to be a danger to a pa-
tient and confirming that the manufacturer—
(A) has ceased sale and distribution of the
unapproved drug or medical device pending
completion of an investigation to determine the
actual cause of the danger; and
(B) has notified health care practitioners
to which the unapproved drug or medical device
has been sent of the information it has received.
(c) INVESTIGATION.—
(1) IN GENERAL.—The Director of the Centers
for Disease Control and Prevention, upon receipt of
the information described in subsection (a), shall
conduct an investigation of the unapproved drug or
medical device that a health care practitioner has
determined to cause a danger to a patient in order
to make a determination of the actual cause of such
danger.
(2) REPORT TO SECRETARY.—The Director of
the Centers for Disease Control and Prevention shall
prepare and submit a report to the Secretary re-
garding the determination made under paragraph
(1), including a determination concerning whether
the unapproved drug or medical device is or is not
the actual cause of danger or whether the actual
cause of danger cannot be determined.
(3) DUTY OF SECRETARY.—Upon receipt of the
report described in paragraph (2), the Secretary
shall—
(A) if the Director of the Centers for Dis-
ease Control and Prevention determines that
the cause of such danger is the unapproved
drug or medical device, direct the manufacturer
of such drug or medical device to—
(i) cease manufacture, sale, and dis-
tribution of such drug or medical device;
and
(ii) notify all health care practitioners
to whom the manufacturer has provided
such drug or medical device to cease using
or recommending such drug or medical de-
vice, and to return such drug or medical
device to the manufacturer as part of a
complete recall;
(B) if the Director of the Centers for Dis-
ease Control and Prevention determines that
the cause of such danger is not such drug or
medical device, direct the manufacturer of such
drug or medical device to inform all health care
practitioners to whom the manufacturer has
provided such drug or medical device of such
a determination; and
(C) if the Director of the Centers of Dis-
ease Control and Prevention cannot determine
the cause of the danger, direct the manufac-
turer of the drug or medical device to inform all
health care practitioners to whom the manufac-
turer has provided such drug or medical device
of such a determination.
(d) SECRETARY’S DUTY TO INFORM.—Upon receipt
of the report described in subsection (b)(3), the Secretary
shall promptly disseminate information concerning the
danger to all health care practitioners in the United
States, to the Director of the National Center for Com-
plementary and Alternative Medicine, and to agencies of
the States that have responsibility for regulating unsafe
or adulterated drugs and medical devices.
SEC. 5. REPORTING OF RESULTS OF UNAPPROVED DRUGS
AND MEDICAL DEVICES.
(a) REPORTING OF RESULTS.—If a health care prac-
titioner provides or administers an unapproved drug or
medical device, that in the opinion of the health care prac-
titioner, produces results that are more beneficial than re-
sults produced from any drug or medical device approved
by the Food and Drug Administration, or produces other
results regarding the effectiveness of the treatment rel-
ative to treatments approved by the Food and Drug Ad-
ministration for the same condition, the practitioner shall
provide to the manufacturer—
(1) the results of the administration of the drug
or device;
(2) a written evaluation of the patient’s medical
condition before and after administration of the un-
approved drug or medical device;
(3) the name, occupation, business address, and
business telephone number of the physician;
(4) the name of the unapproved drug or med-
ical device and a description of the method of oper-
ation and administration, dosing, and duration of
treatment; and
(5) an affidavit pursuant to section 1746 of
title 28, United States Code, confirming that all
statements made to the manufacturer are accurate.
(b) MANUFACTURER’S
DUTY
TO
REPORT.—Any
manufacturer of an unapproved drug or medical device
that receives information under subsection (a) shall pro-
vide to the Director of the National Center for Com-
plementary and Alternative Medicine—
(1) a complete copy of the information;
(2) the name, business address, and business
telephone number of the manufacturer;
(3) the name, business address, and business
telephone number of the health care practitioner who
supplied information to the manufacturer;
(4) the name of the unapproved drug or med-
ical device;
(5) the known method of operation and admin-
istration of the unapproved drug or medical device;
(6) the per unit dose; and
(7) the intended use of the unapproved drug or
medical device.
(c) DIRECTOR’S DUTY TO MAKE PUBLIC.—The Di-
rector of the National Center for Complementary and Al-
ternative Medicine shall review and analyze information
received pursuant to subsection (b) about an unapproved
drug or medical device and make available, on an Internet
website and in writing upon request by any individual, an
annual review and analysis of such information, and in-
clude a statement that such drug or medical device is not
approved by the Food and Drug Administration.
SEC. 6. OTHER LAWS NOT AFFECTED BY THIS ACT.
This Act—
(1) shall not be construed—
(A) to have any effect on section 503A of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353a); or
(B) to supersede any law of a State or po-
litical subdivision of a State, including laws gov-
erning rights and duties among health care
practitioners and patients;
(2) shall not apply to statements or claims per-
mitted or authorized under sections 403 and 403B
of such Act (21 U.S.C. 343, 343–2); and
(3) shall not in any way adversely affect the
distribution or sale of dietary supplements (as de-
fined in section 201(ff) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(ff)).
SEC. 7. AUTHORIZED ACTIVITIES OF HEALTH CARE PRAC-
TITIONERS.
(a) INTRODUCTION IN INTERSTATE COMMERCE.—To
the extent necessary to comply with this Act, a health care
practitioner may—
(1) introduce an unapproved drug or medical
device into interstate commerce;
(2) deliver an unapproved drug or medical de-
vice for introduction into such commerce;
(3) transport an unapproved drug or medical
device in such commerce;
(4) receive an unapproved drug or medical de-
vice in such commerce and deliver the unapproved
drug or medical device; and
(5) hold an unapproved drug or medical device
for sale after shipment of the unapproved drug or
medical device in such commerce.
(b) RULE OF CONSTRUCTION.—This Act shall not be
construed to limit or interfere with the authority of a
health care practitioner to prescribe, recommend, provide
or administer to a patient for any condition or disease any
unapproved drug or medical device lawful under the law
of the State or States in which the health care practitioner
practices.
SEC. 8. PENALTY.
A health care practitioner or manufacturer found to
have knowingly violated this Act shall be denied coverage
under this Act.
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