1.This Act may be cited as the
Access to Medical Treatment
Act
.
2.In this Act:
(1)The term advertising claim means any
representation made or suggested by statement, word, design, device, sound, or
any combination thereof with respect to a medical treatment.
(2)The
term danger means an adverse reaction to an unapproved drug or
medical device that, when used as directed—
(A)causes serious
harm;
(B)occurred as a
result of the medical treatment;
(C)would not
otherwise have occurred; and
(D)is more serious
than reactions experienced with routinely used medical treatments approved by
the Food and Drug Administration for the same medical condition or
conditions.
(3)The
term device has the meaning given such term in section 201(h) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(h)).
(4)The
term drug has the meaning given such term in section 201(g)(1) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(g)(1)).
(5)The
term food—
(A)has the meaning
given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(f)); and
(B)includes a dietary
supplement as defined in section 201(ff) of such Act.
(6)The term health care practitioner means
a physician or other individual who is legally authorized to provide health
care services in the State in which the services are provided.
(7)The term interstate 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 legislative body.
(8)The
term label has the meaning given such term in section 201(k) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(k)).
(9)The
term labeling has the meaning given such term in section 201(m) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(m)).
(10)The term legal representative means a
parent or an individual who qualifies as a legal guardian under applicable
State law.
(11)The term medical device has the meaning given
the term device in section 201(h) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)).
(12)The term medical treatment means any food,
drug, device, or procedure that is used and intended as a cure, mitigation,
treatment, or prevention of disease or a health condition.
(13)The
term patient means any individual who seeks medical treatment from
a health care practitioner for a disease or health condition.
(14)The
term Secretary means the Secretary of Health and Human
Services.
(15)The
term seller means an individual or organization that receives
payment related to the medical treatment of a patient of a health practitioner,
except that this term does not apply to a health care practitioner who receives
payment from an individual or representative of such individual for the
administration of a medical treatment to such individual.
(16)Unapproved drug
or medical deviceThe term unapproved drug or medical
device with respect to a drug or medical device, means a drug or medical
device that is not approved or authorized for manufacture, sale, and
distribution in interstate commerce under sections 505, 510, or 515 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C 355, 360c, and 360(e)) or under section 351 of the
Public Health Service Act (42 U.S.C.
262).
3.Access to medical
treatment
(a)Notwithstanding any other provision of law, and except as
provided in subsection (b), an individual shall have the right to be treated by
a health care practitioner with any medical treatment (including a medical
treatment that is not approved, certified, or licensed by the Secretary) that
such individual desires, or that the legal representative of such individual
authorizes, if—
(1)such practitioner
has personally examined such individual and agrees to provide treatment to such
individual;
(2)the administration
of such treatment does not violate applicable licensing laws;
(3)the health care
practitioner complies with the requirements of subsection (b); and
(4)it is a medical treatment that has not been
approved, certified, or licensed by the Secretary, or is any medical treatment
that has been approved by the designated governmental agency for a member
country of the European Union or the European Free Trade Association, Canada,
Australia, New Zealand, or Japan but not otherwise approved, certified, or
licensed by the Secretary.
(b)Medical
treatment requirements
(1)A health care practitioner may provide the medical
treatment requested by an individual described in subsection (a) if—
(A)there is no reason
for the practitioner to conclude that, based on generally accepted principles
and current information, the medical treatment requested, when used or provided
as directed, will cause danger to the patient;
(B)in the case of an
individual whose treatment is the administration of a food, drug, or device
that has to be approved, certified, or licensed by the Secretary, but has not
been so approved, certified, or licensed—
(i)such
individual has been informed in writing that such food, drug, or device has not
been approved, certified, or licensed by the Secretary for use as a medical
treatment of the medical condition of such individual; and
(ii)prior to the
administration of such treatment, the practitioner has provided the patient a
written statement that includes the following provision: WARNING: This
food, drug, or device has not been declared to be safe and effective by the
Federal Government and any individual who uses such food, drug, or device does
so at his or her own risk.
;
(C)such individual
has been informed in writing of the nature of the medical treatment,
including—
(i)the
contents and methods of such treatment;
(ii)the
anticipated benefits of such treatment;
(iii)any reasonably
foreseeable side effects that may result from such treatment;
(iv)the
results of past application of such treatment by the health care practitioner
and others; and
(v)any
other information necessary to fully meet the requirements for informed consent
of human subjects prescribed by regulations issued by the Food and Drug
Administration;
(D)except as provided
in subsection (c), there have been no advertising claims made with respect to
the efficacy of the medical treatment by the practitioner, manufacturer, or
distributor;
(E)the label or
labeling of any food, drug, or device that is a part of the requested medical
treatment is not false or misleading;
(F)such
individual—
(i)has
been provided with a written statement that such individual has been fully
informed with respect to the information described in subparagraphs (A) through
(D);
(ii)desires such
treatment; and
(iii)signs such
statement; and
(G)the health care
practitioner provides the patient with a recommendation for the treatment
involved under circumstances that give the patient sufficient opportunity to
consider whether or not to use such treatment.
(2)In any proceeding relating to the enforcement of paragraph
(1)(E) with respect to the label of a drug, device, or food used in medical
treatment covered under this subsection, the provisions of section 403B(c) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 343–2(c)) shall apply with respect to establishing
the burden of proof that such label is false or misleading.
(3)Nothing in this section shall be construed to
require informed consent for the prescription of dietary supplements and foods
not requiring such informed consent prior to the date of the enactment of this
Act.
(c)
(1)Reporting by a
health care practitionerSubsection (b)(1)(D) shall not apply to
an accurate and truthful reporting by a health care practitioner of the results
of the practitioner’s administration of a medical treatment in recognized
journals, at seminars, conventions, or similar meetings, or to others, so long
as the reporting practitioner has no direct or indirect financial interest in
the reporting of the material and has received no financial benefits of any
kind from the manufacturer, distributor, or other seller for such reporting.
Such reporting may not be used by a manufacturer, distributor, or other seller
to advance the sale of such treatment.
(2)Statements by a
practitioner to a patientSubsection (b)(1)(D) shall not apply to
any statement made by a health care practitioner directly to a patient or
prospective patient. A health care practitioner shall not be held liable for
any advertising claims made by others unless the practitioner is a party in the
dissemination of the information in such claims.
(3)Dietary
supplements statementSubsection (b)(1)(D) shall not apply to
statements or claims permitted under sections 403B and 403(r)(6) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343–2 and 343(r)(6)).
4.Reporting of a
dangerous medical treatment
(a)If a health care practitioner, after administering a
medical treatment, discovers that the treatment itself was a danger to the
individual receiving such treatment, the practitioner shall—
(1)immediately cease
the use of such treatment;
(2)refrain from
recommending the use of any unapproved drug or medical device that was a part
of such treatment;
(3)report to the
manufacturer and the Director of the Centers for Disease Control and
Prevention—
(A)the nature of such
treatment;
(B)the results of
such treatment;
(C)the complete
protocol of such treatment; and
(D)the source from
which such treatment or any part thereof was obtained; and
(4)include as part of
the reporting under paragraph (3), an affidavit pursuant to section 1746 of
title 28, United States Code, confirming that all statements made in the report
under such paragraph are accurate.
(b)Upon
confirmation that a medical treatment has proven dangerous to individuals, the
Secretary shall properly disseminate information with respect to the danger of
the medical treatment and prohibit the further use of such treatment.
5.Reporting of a
beneficial medical treatmentIf a health care practitioner, after
administering a medical treatment that is not an approved drug or medical
device for a life-threatening medical condition or conditions, discovers that
such medical treatment has, in the opinion of the health care practitioner,
positive effects on such condition or conditions that are significantly greater
than the positive effects that are expected from an approved medical treatment
for the same condition or conditions, the practitioner shall—
(1)make a monthly
reporting to the National Center for Complementary and Alternative Medicine at
the National Institutes of Health of—
(A)the nature of such
medical treatment (which is not a conventional medical treatment);
(B)the general
results of such treatment administered in the month involved; and
(C)the protocol of
such treatment; and
(2)provide an
affidavit pursuant to section 1746 of title 28, United States Code, confirming
that all statements made in the monthly reporting under paragraph (1) are
accurate and truthful.
6.Transportation
and production of food, drugs, devices, and other equipment
(a)Notwithstanding any other provision of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 201 et seq.), an individual may—
(1)introduce or
deliver into interstate commerce a food, drug, device, or any other equipment;
and
(2)produce,
transport, receive and hold a food, drug, device, or any other
equipment,
solely for
use in accordance with this Act if there have been no advertising claims by the
manufacturer, distributor, or seller of the food, drug, device, or equipment
involved.(b)Nothing in this Act shall 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 medical condition or
disease any unapproved drug or medical device that is lawful under the law of
the State or States in which the health care practitioner practices.
7.Other laws not
affected by this ActNothing
in this Act shall be construed to—
(1)apply to the
manufacturer, distribution, possession, or use of any drug that is a controlled
substance under the Controlled Substances
Act (21 U.S.C. 801 et seq.);
(2)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, 343–2); or
(3)in any way
adversely affect the distribution or sale of dietary supplements (as defined in
section 201(ff) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(f))).
8.A health care practitioner who knowingly
violates any provision of this Act shall not be covered by the protections
under this Act and shall be subject to all other applicable laws and
regulations.