(1) there is no reasonable basis to conclude that
the medical treatment itself, when used as directed,
poses an unreasonable and significant risk of danger
to such individual;
(2) 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 Sec-
retary of Health and Human Services, but has not
been approved, certified, or licensed by the Secretary
of Health and Human Services—
(A) such individual has been informed in
writing that such food, drug, or device has not
yet been approved, certified, or licensed by the
Secretary of Health and Human Services for
use as a medical treatment for the condition of
such individual; and
(B) prior to the administration of such
treatment, the practitioner has provided the pa-
tient a written statement that states the follow-
ing:
‘‘WARNING: This food, drug, or de-
vice 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.’’;
(3) such individual has been informed in writ-
ing of the nature of the medical treatment, includ-
ing—
(A) the contents and methods of such
treatment;
(B) the anticipated benefits of such treat-
ment;
(C) any reasonably foreseeable side effects
that may result from such treatment;
(D) the results of past applications of such
treatment by the health care practitioner and
others; and
(E) any other information necessary to
fully meet the requirements for informed con-
sent of human subjects prescribed by regula-
tions issued by the Food and Drug Administra-
tion;
(4) except as provided in subsection (c), there
have been no advertising claims made with respect
to the efficacy of the medical treatment by the prac-
titioner, manufacturer, or distributor;
(5) the label of any drug, device, or food used
in such treatment is not false or misleading; and
(6) such individual—
(A) has been provided a written statement
that such individual has been fully informed
with respect to the information described in
paragraphs (1) through (4);
(B) desires such treatment; and
(C) signs such statement.
In any proceeding relating to the enforcement of para-
graph (5) with respect to the label of drugs, devices, or
food used in medical treatment covered under this sub-
section, the provisions of section 403B(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343-2(c)) shall
apply to establishing the burden of proof that such label
is false or misleading.
(c) CLAIM EXCEPTIONS.—
(1) REPORTING
BY
A
PRACTITIONER.—Sub-
section (b)(4) 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 or at semi-
nars, conventions, or similar meetings or to others
so long as the reporting practitioner has no financial
interests in the reporting of the material and has re-
ceived no financial benefit 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 PA-
TIENT.—Subsection (b)(4) shall not apply to any
statement made in person by a health care practi-
tioner to an individual patient or an individual pro-
spective patient.
(3) DIETARY
SUPPLEMENTS
STATEMENTS.—
Subsection (b)(4) 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)).
SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREAT-
MENT.
(a) HEALTH CARE PRACTITIONER.—If a health care
practitioner, after administering a medical treatment, dis-
covers that the treatment itself was a danger to the indi-
vidual receiving such treatment, the practitioner shall im-
mediately report to the Secretary of Health and Human
Services the nature of such treatment, the results of such
treatment, the complete protocol of such treatment, and
the source from which such treatment or any part thereof
was obtained.
(b) SECRETARY.—Upon confirmation that a medical
treatment has proven dangerous to an individual, the Sec-
retary of Health and Human Services shall properly dis-
seminate information with respect to the danger of the
medical treatment.
SEC. 5 REPORTING OF A BENEFICIAL MEDICAL TREAT-
MENT.
If a health care practitioner, after administering a
medical treatment that is not a conventional medical treat-
ment for a life-threatening medical condition or condi-
tions, discovers that, in the opinion of the practitioner,
such medical treatment has positive effects on such condi-
tion or conditions that are significantly greater than the
positive effects that are expected from a conventional med-
ical treatment for the same condition or conditions, the
practitioner shall immediately make a reporting, which is
accurate and truthful, to the Office of Alternative Medi-
cine of—
(1) the nature of such medical treatment (which
is not a conventional medical treatment);
(2) the results of such treatment; and
(3) the protocol of such treatment.