I
106TH CONGRESS
1ST SESSION
H. R. 2635
To allow patients access to drugs and medical devices recommended and
provided by health care practitioners that are not approved by the Food
and Drug Administration, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 29, 1999
Mr. DEFAZIO (for himself, Mr. BURTON of Indiana, Mr. SANDERS, Mr. HIN-
CHEY, Mr. HAYWORTH, Mr. OWENS, Mr. CAMPBELL, Mr. ROHR-
ABACHER, Mr. ANDREWS, Mr. DREIER, Mr. WYNN, Mr. PAUL, Mr. LI-
PINSKI, Mrs. MYRICK, Mr. FILNER, Mr. STUMP, Mr. RAHALL, Ms.
WOOLSEY, Mr. ACKERMAN, Mr. DUNCAN, Mr. COSTELLO, Mr. OBER-
STAR, Mr. FARR of California, and Mr. TAYLOR of North Carolina) intro-
duced the following bill; which was referred to the Committee on Com-
merce
A BILL
To allow patients access to drugs and medical devices rec-
ommended and provided by health care practitioners that
are not approved by the Food and Drug Administration,
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’’.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Avoiding regulation that lessens or impairs
the health status of the people of the United States
is a priority of the Federal Government.
(2) The quality of health care in the United
States depends primarily on the freedom of each pa-
tient to choose a medical treatment recommended by
a health care practitioner and the freedom of each
health care practitioner to exercise independent pro-
fessional judgment in the selection and recommenda-
tion of a treatment that the professional deems most
likely to satisfy the unique needs and tolerances of
the patient.
(3) In the treatment of patients, health care
practitioners must be free to recommend drugs and
medical devices not approved by the Food and Drug
Administration if in the practitioner’s independent
professional judgment such drugs and medical de-
vices are necessary and offer hope of saving life, re-
establishing health, or alleviating suffering.
(4) Certain diseases may not be cured by drugs
or medical devices approved by the Food and Drug
Administration.
(5) Drugs and medical devices approved by the
Food and Drug Administration are sometimes inju-
rious to health when administered to particular pa-
tients.
(6) Patients sometimes prefer not to be treated
with drugs or medical devices approved by the Food
and Drug Administration.
(7) In consultation with a health care practi-
tioner, each patient has a right to freedom of choice
in deciding what drugs to take and what medical de-
vices to have applied to his or her own body.
(8) Although the Federal Government should
act swiftly to halt the manufacture, sale, and dis-
tribution of drugs and medical devices that are adul-
terated within the meaning of this Act, it should not
take any action to interfere with a health care prac-
tice regulated by the States.
(9) Many drugs and medical devices not ap-
proved by the Food and Drug Administration for
manufacture, sale, and distribution in the United
States, including those marketed lawfully in other
countries, may be desired by patients and rec-
ommended by health care practitioners.
(10) Existing State laws governing the practice
of medicine and this Act provide adequate protection
for practitioner-recommended patient use of drugs
and medical devices not approved by the Food and
Drug Administration.
SEC. 3. DEFINITIONS.
As used in this Act:
(1) ADVERTISING CLAIMS.—The term ‘‘adver-
tising claims’’ means proposals to engage in com-
mercial transactions involving the sale of an unap-
proved drug or medical device at a price above costs.
(2) 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 or that causes a danger to a pa-
tient.
(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.
(4) DANGER.—The term ‘‘danger’’ means an
adverse reaction to an unapproved drug or medical
device that—
(A) causes serious harm when used as di-
rected;
(B) would not otherwise have occurred;
and
(C) is more serious than contraindications
for drugs or medical devices approved by the
Federal Food and Drug Administration 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 person authorized to provide health care serv-
ice in the State in which the service is performed.
(7) LEGAL REPRESENTATIVE.—The term ‘‘legal
representative’’ means a parent or other person who
qualifies as a legal guardian under State law.
(8) MEDICAL DEVICE.—The term ‘‘medical de-
vice’’ has the same meaning given that term in sec-
tion 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(h)).
(9) UNAPPROVED DRUG OR MEDICAL DEVICE.—
The term ‘‘unapproved’’, with respect to a drug or
medical device, means a new drug or medical device
that is not approved or authorized for manufacture,
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).
(10) PATIENT.—The term ‘‘patient’’ means any
person who seeks medical treatment from a health
care practitioner for a disease or disease condition.
(11) 
SECRETARY.—The 
term 
‘‘Secretary’’
means the Secretary of the Department of Health
and Human Services.
(12) SELLER.—The term ‘‘seller’’ means a per-
son, company, or organization that receives payment
for an unapproved drug or medical device, except
that this term does not apply to a health care practi-
tioner who receives payment from a patient or legal
representative of a patient for medical services, in-
cluding the administration of an unapproved drug or
medical device unless the health care practitioner is
also the manufacturer of the unapproved drug or
medical device.
SEC. 4. ACCESS TO MEDICAL TREATMENT.
(a) 
IN
GENERAL.—Notwithstanding 
sections
501(a)(2)(B), 501(e) through 501(h), 502(f)(1), 513,
505, and 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(a)(2)(B), 351(c) through 351(h),
351(e), 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, any unapproved
drug or medical device that the patient desires or the legal
representative of the patient authorizes if—
(1) the unapproved drug or medical device is
recommended by a health care practitioner within
that practitioner’s scope of practice under State law;
(2) the administration of the unapproved drug
or medical device is not a violation of the laws of the
State or States in which the activity is carried out;
and
(3) the health care practitioner abides by all of
the recommendation requirements in subsection (b).
(b) RECOMMENDATION REQUIREMENTS.—A health
care practitioner may recommend and provide any unap-
proved drug or medical device to 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 by providing or administering the unapproved
drug;
(3) has concluded that the unapproved drug or
medical device, used as directed, will not pose a dan-
ger to the patient;
(4) has informed the patient in writing, prior to
recommending or providing the unapproved 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) that the patient may suspend or termi-
nate treatment at any time;
(C) the currently indicated and generally
accepted treatment or treatments for the pa-
tient’s condition, if any;
(D) interactions the unapproved drug or
medical device may have with other drugs, if
any;
(E) the active and inactive ingredients of
the unapproved drug and the mechanism of ac-
tion, if known;
(F) the mechanism of action of the medical
device;
(G) the health condition for which the un-
approved drug or medical device is provided, the
method of administration that the patient
should or the health care practitioner will use,
and the unit dose;
(H) the opinion of the health care practi-
tioner concerning the risks and benefits of the
unapproved drug or medical device, including
any expected possible side effects; and
(I) any other information or disclosures re-
quired by applicable State law for the adminis-
tration of experimental drugs or medical devices
to human subjects;
(5) has not made, except as provided in sub-
section (c), any advertising claims for the unap-
proved drug or medical device;
(6) does not impose a charge for the unap-
proved drug or medical device in excess of costs;
(7) complies with requirements for reporting a
danger in section 5; and
(8) has received a signed affidavit from the pa-
tient or the patient’s legal representative confirming
that the patient or the legal representative—
(A) has received the written information
required by subsection (b)(4)(A)–(I) and under-
stands it; and
(B) desires treatment with the unapproved
drug or medical device as recommended by the
health care practitioner.
(c) ADVERTISING CLAIMS EXCEPTION.—
(1) REPORTING BY A HEALTH CARE PRACTI-
TIONER.—Subsection (b)(5) shall not apply to a
health care practitioner’s dissemination of informa-
tion on the results of the practitioner’s administra-
tion of the unapproved drug or medical device unless
the health care practitioner makes an offer to sell
the unapproved drug or medical device in connection
with the dissemination of that information.
(2) DIETARY
SUPPLEMENT
STATEMENTS.—
Subsection (b)(5) shall not apply to statements or
claims permitted or authorized under sections 403
and 403B of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 343 and 343–2).
SEC. 5. 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
device creates a danger to a patient, the practitioner shall
immediately cease use and recommendation of the unap-
proved drug or medical device and provide to the manufac-
turer of the unapproved drug or medical device—
(1) a written evaluation of the patient’s medical
condition before and after administration of the un-
approved drug or medical device;
(2) a written evaluation of the adverse reaction,
including its physiological manifestations, duration,
and the effect of cessation of treatment upon the pa-
tient’s condition;
(3) any other information the health care prac-
titioner deems pertinent to an evaluation of the ad-
verse reaction;
(4) the name, occupation, business address, and
business telephone number of the physician;
(5) the name of the unapproved drug or med-
ical device and a description of the method of ad-
ministration and operation, dosing, and duration of
treatment;
(6) the lot number, if any, of the unapproved
drug or medical device; and
(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—