(1) cease sale and distribution of the unap-
proved drug or medical device pending completion of
an investigation by the manufacturer 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 by the manufac-
turer to determine the actual cause of the dan-
ger; 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) MANUFACTURER’S DUTY TO INVESTIGATE.—
Upon receipt of the information described in subsection
(a), the manufacturer shall commence an investigation to
determine the actual cause of the danger, and shall carry
out the following, as applicable:
(1) If the actual cause is determined to be the
unapproved drug or medical device, the manufac-
turer shall cease manufacture, sale, and distribution
of the unapproved drug or medical device; shall no-
tify all health care practitioners to whom the manu-
facturer has provided the unapproved drug or med-
ical device to cease use and recommendation of the
unapproved drug or medical device and return the
unapproved drug or medical device to the manufac-
turer for a complete recall; and shall notify the Sec-
retary that it has taken each of the foregoing steps.
(2) If the actual cause is determined not to be
the unapproved drug or medical device, the manu-
facturer shall inform all health care practitioners to
whom the manufacturer has provided the unap-
proved drug or medical device of that determination
and of any recommendations on use or modifications
of the unapproved drug or medical device the manu-
facturer deems appropriate and shall notify the Sec-
retary that it has taken each of the foregoing steps.
(3) If the actual cause is not determined, the
manufacturer shall inform all health care practi-
tioners to whom the manufacturer has provided the
unapproved drug or medical device of that finding;
shall make any recommendations on use or modifica-
tions of the unapproved drug or medical device the
manufacturer deems appropriate; and shall notify
the Secretary that it has taken each of the foregoing
steps.
(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. 6. REPORTING OF BENEFICIAL DRUGS AND MEDICAL
DEVICES.
(a) REPORTING
OF BENEFICIAL RESULTS.—If a
health care practitioner discovers that an unapproved drug
or medical device used in the treatment of a life threat-
ening medical condition produces results that, in the opin-
ion of the practitioner, are significantly more beneficial
than results produced from a drug or medical device ap-
proved by the Food and Drug Administration for the same
condition or conditions, the practitioner shall provide to
the manufacturer 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) the name, occupation, business address, and
business telephone number of the physician;
(3) 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
(4) 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) NOTICE
TO CONGRESS
OF BENEFICIAL RE-
SULTS.—Each year on the fifteenth day of January after
the date of enactment of this Act, the Director of the Na-
tional Center for Complementary and Alternative Medicine
shall submit to Congress a report accurately summarizing
all information it has received under subsection (b). The
Director and the Congress shall make the Director’s re-
port available to the public.
SEC. 7. OTHER LAWS NOT AFFECTED BY THIS ACT.
This Act does not have any effect on section 503A
of the Federal Food, Drug, and Cosmetic Act nor does
this Act supersede any law of a State or political subdivi-
sion of a State, including laws governing rights and duties
among health care practitioners and patients.
SEC. 8. AUTHORIZED ACTIVITIES OF HEALTH CARE PRAC-
TITIONERS.
In conformity with the provisions of this Act, a health
care practitioner may introduce an unapproved drug or
medical device into interstate commerce; deliver an unap-
proved drug or medical device for introduction into such
commerce; transport an unapproved drug or medical de-
vice in such commerce; receive an unapproved drug or
medical device in such commerce and deliver the unap-
proved drug or medical device; and hold an unapproved
drug or medical device for sale after shipment of the unap-
proved drug or medical device in such commerce. This Act
shall not be construed to limit or interfere with the author-
ity of a health care practitioner to prescribe, recommend,
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. 9. PENALTY.
A health care practitioner found to have knowingly
violated this Act shall be denied coverage under this Act.
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