nostic and prevention modalities, disciplines and 
systems. 
‘‘(B) The Director maintains the informa-
tion received under subparagraph (A); makes 
such information available to health care practi-
tioners and the general public through estab-
lishing one or more Internet sites; and receives, 
maintains, and makes available through such 
site appropriate comments and information pro-
vided in response to such information. 
‘‘(C) The Director carries out subpara-
graph (B) in a manner reasonably calculated to 
provide a forum for obtaining and dissemi-
nating information, including clinical data, to-
ward the following goals: 
‘‘(i) Identifying alternative treatment, 
diagnostic and prevention systems, modali-
ties, and disciplines that should be inte-
grated with the practice of conventional 
medicine as a complement to such medi-
cine and integrated into health care deliv-
ery systems in the United States. 
‘‘(ii) Identifying any alternative med-
ical practices or procedures that constitute 
a threat to the public health. 
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‘‘(iii) Making available to the Commis-
sioner of Food and Drugs information for 
uses with respect to promoting innovations 
in evidence-based clinical practice and 
health care technologies under title IX of 
the Public Health Service Act. 
‘‘(2) DIETARY SUPPLEMENTS AND FOOD.—In 
consultation with the Commissioner of Food and 
Drugs, the Director of the Center shall carry out the 
following: 
‘‘(A) Activities under paragraph (1) shall 
include carrying out such paragraph with re-
spect to information that relates to the effects 
of dietary supplements and food on diseases 
and disorders and is obtained by the practi-
tioners in the course of their professional prac-
tices and submitted to the Director. 
‘‘(B) With respect to paragraph (1)(C) as 
applied for purposes of this paragraph, the 
goals shall be the following: 
‘‘(i) Identifying dietary supplements 
and food and uses of such supplements 
and food that are of clinical benefit in 
treating particular diseases or disorders. 
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‘‘(ii) As appropriate, providing for the 
publication of authoritative statements, 
within 
the 
meaning 
of 
section 
403(r)(3)(C)(i) of the Federal Food, Drug, 
and Cosmetic Act, about the relationship 
between a nutrient and a disease or health- 
related condition. 
‘‘(iii) 
Carrying 
out 
paragraph 
(1)(C)(iii) with respect to dietary supple-
ments. 
‘‘(3) VOLUNTARY
PARTICIPATION.—Paragraph 
(1) may not be construed as requiring that any 
health care practitioner or other person participate 
in the program under such paragraph. 
‘‘(4) CERTAIN AUTHORITIES.—The posting by 
the Director of the Center of information on the 
Internet site under paragraph (1) is subject to the 
following: 
‘‘(A) The Director may not post informa-
tion submitted by a health care practitioner un-
less the practitioner authorizes the Director to 
include in the posting the identity and the busi-
ness address of the practitioner. 
‘‘(B) The Director may impose reasonable 
restrictions on the format and volume of infor-
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mation to be posted and on the frequency of 
postings. 
‘‘(5) CRITERIA.—Not later than one year after 
the date of the enactment of the Medical Informa-
tion and Treatment Access Act, the Secretary shall 
by regulation issue criteria for carrying out this sub-
section. 
‘‘(6) DEFINITIONS.—For purposes of this sub-
section, the terms ‘dietary supplement’ and ‘food’ 
have the meaning given such terms in section 201 
of the Federal Food, Drug, and Cosmetic Act.’’. 
TITLE IV—LEGAL IMMUNITY OF 
DRUG AND DEVICE COMPANIES 
SEC. 401. IMMUNITY FROM LIABILITY. 
(a) LOSS ARISING FROM USE
OF UNAPPROVED 
TREATMENTS BY PRACTITIONERS.— 
(1) IN GENERAL.—A drug or device company 
(referred to in this section as a ‘‘company’’) is im-
mune from suit and liability under Federal and 
State law with respect to all claims for loss arising 
from the use of a relevant unapproved treatment by 
a practitioner under a cleared registration under sec-
tion 203(a). 
(2) RELEVANT
UNAPPROVED
TREATMENT.— 
For purposes of this section, the term ‘‘relevant un-
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approved treatment’’, with respect to a company, 
means a treatment that uses an approved drug or 
device that is manufactured by the company, which 
use— 
(A) is an unapproved use that does not in-
volve any changes to the drug or device as man-
ufactured by the company; or 
(B) involves changes to the drug or device 
as manufactured by the company and causes 
the drug or device to be unapproved. 
(3) LOSS.—For purposes of this subsection, the 
term ‘‘loss’’ means any type of loss, including— 
(A) death; 
(B) physical, mental, or emotional injury, 
illness, disability, or condition; 
(C) fear of physical, mental, or emotional 
injury, illness, disability, or condition, including 
any need for medical monitoring; and 
(D) loss of or damage to property, includ-
ing business interruption loss. 
(4) RULE OF CONSTRUCTION REGARDING USE 
OF
UNAPPROVED
TREATMENT.—For purposes of 
paragraph (1), a practitioner shall be considered to 
have used a relevant unapproved treatment if the 
practitioner— 
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(A) treated himself or herself with the 
treatment; or 
(B) treated a patient with the treatment, 
whether by administering the treatment to the 
patient directly or by providing for self-adminis-
tration by the patient. 
(b) PROVISION OF INFORMATION TO PRACTITIONERS 
UPON REQUEST.— 
(1) IN GENERAL.—A company is immune from 
suit and liability under Federal and State law with 
respect to any claim arising from the provision by 
the company of information on a drug or device 
manufactured by the company in circumstances in 
which— 
(A) the information is provided to a practi-
tioner in response to a request made to the 
company by the practitioner; and 
(B) the information is reasonably believed 
by the company to be accurate. 
(2) RELATION TO CLEARED REGISTRATION.— 
Paragraph (1) applies without regard to whether the 
drug or device involved is used as or in a relevant 
unapproved treatment for which a cleared registra-
tion under section 203(a) has been obtained. 
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(1) title II takes effect on the date on which the 
final rules required under sections 203(e)(1) and 
204(e) take effect; 
(2) section 301 takes effect on the date on 
which the final rule required under subsection (d) of 
such section takes effect; and 
(3) the amendment made by section 302 takes 
effect on the date on which the final rule required 
under section 485D(i)(5) of the Public Health Serv-
ice Act (as added by such amendment) takes effect. 
(b) ISSUANCE
OF CRITERIA.—Sections 203(e)(1), 
204(e), and 301(d) of this Act, and section 485D(i)(5) 
of the Public Health Service Act (as added by section 302 
of this Act), take effect on the date of the enactment of 
this Act. 
Æ 
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