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
section 505, 513, 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 and is within the scope of the practice
of such practitioner;
(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, which
shall become part of the medical record of the patient, 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
746 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)If an individual imports a shipment of a
food, drug, device, or any other equipment, the individual shall notify the
Secretary of any such shipment.
(c)Production of
unapproved drugs, devices, and other equipmentIn the case of unapproved drugs, devices,
or other equipment, except those approved by a country listed in section
3(a)(4), a manufacturer shall provide notice the Secretary of the intent of
such manufacturer to deliver the product into interstate commerce.
(d)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 manufacture, distribution,
possession, administration, recommendation, prescription, or provision, or
support the 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(f) 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.