SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Information 
and Treatment Access Act’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Findings. 
TITLE I—FEDERAL INTERNET SITE FOR CONSOLIDATION AND 
TRANSLATION OF INFORMATION ON DISEASES AND OTHER 
CONDITIONS 
Sec. 101. Internet site. 
TITLE II—PATIENT AND PRACTITIONER RIGHTS REGARDING 
PRACTICE OF MEDICINE 
Sec. 201. Patient and practitioner rights. 
Sec. 202. General safeguards. 
Sec. 203. Federal registration of unapproved treatments; determination regard-
ing safety. 
Sec. 204. Unapproved treatments; John Eisenberg forum for facilitating ex-
change of information in scientific and medical community. 
Sec. 205. Relation to other laws. 
Sec. 206. Authorization of appropriations. 
TITLE III—ADDITIONAL FORUMS FOR EXCHANGE OF HEALTH 
INFORMATION 
Sec. 301. John Eisenberg forum regarding surgical procedures. 
Sec. 302. John Eisenberg forum regarding complementary and alternative med-
icine; dietary supplements and food. 
TITLE IV—LEGAL IMMUNITY OF DRUG AND DEVICE COMPANIES 
Sec. 401. Immunity from liability. 
TITLE V—GENERAL PROVISIONS 
Sec. 501. Definitions. 
Sec. 502. Effective dates. 
SEC. 3. FINDINGS. 
The Congress finds as follows: 
(1) The Congress and the American people de-
sire to live healthy lives and foster an effective and 
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efficient health care system. This system requires 
timely, accurate, and ever-improving information re-
sources. This will foster maximization of health care 
outcomes and help health care practitioners and pa-
tients partner for more effective results. 
(2) The Internet is a unique tool offering access 
to great volumes of information. Some is accurate 
and some is not. There has also been extensive gov-
ernment investment in placing medical information 
on the Internet in many diverse places. 
(3) There is a need to consolidate and translate 
this myriad of information for physicians and con-
sumers, from the listing of clinical trials to the pro-
tocols for treatment of various diseases and condi-
tions, as well as the integration of new discoveries 
and the evaluations of outcomes-based examinations 
of drugs and devices for conditions other than those 
for which they are already approved. This will lead 
to more accurate treatment, fewer medical errors, 
and more successful outcomes, while also protecting 
patients, a physician’s right to practice medicine, 
and a patient’s right to access the health care the 
patient desires. 
(4) The Food and Drug Administration is 
uniquely qualified to assist the Nation in fulfilling 
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this mission to improve health care for the benefit 
of Americans. The Administration already coordi-
nates the information needs of many government 
agencies and equivalent regulatory bodies in other 
countries. 
(5) In providing Internet-based forums for ob-
taining and disseminating health-related information 
(including information on surgical procedures; com-
plimentary and alternative medicine; dietary supple-
ments and food; and unapproved treatments), the 
Food and Drug Administration should work closely 
with educational institutions, schools of medicine, 
and other appropriate private entities and ensure 
that the expertise of such entities is appropriately 
utilized. 
TITLE 
I—FEDERAL 
INTERNET 
SITE 
FOR 
CONSOLIDATION 
AND TRANSLATION OF INFOR-
MATION ON DISEASES AND 
OTHER CONDITIONS 
SEC. 101. INTERNET SITE. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall carry out a program whose mission 
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is, through an Internet site maintained for purposes of 
the program— 
(1) to consolidate and translate health care in-
formation that is available to the public from Fed-
eral agencies, linking the various health-related 
Internet sites of such agencies; and 
(2) to assist in the translation and reporting of 
disease or condition protocols for physicians and lay 
persons. 
(b) INFORMATION ON DISEASES AND OTHER CONDI-
TIONS.—The Secretary shall ensure that the Internet site 
under subsection (a) has capacities that enable a user of 
the site to enter the name of a disease or other health 
condition and obtain Internet links appropriate to health 
care providers, and links appropriate to lay persons, that 
provide— 
(1) an explanation of the health condition; and 
(2) information on all available treatment pro-
tocols, including— 
(A) standard medical practice protocols; 
and 
(B) any clinical trials, and any outcomes- 
based treatment protocols, that— 
(i) are being conducted or supported 
by the National Institutes of Health; 
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(ii) are included in the registry and 
results data bank under section 402(j) of 
the Public Health Service Act (42 U.S.C. 
282(j)); 
(iii) are being conducted pursuant to 
the Federal Food, Drug, and Cosmetic Act 
or section 351 of the Public Health Service 
Act; 
(iv) are being conducted pursuant to 
section 201 of this Act; or 
(v) are identified pursuant to section 
301 of this Act or pursuant to section 
485D(i) of the Public Health Service Act 
(as added by section 302 of this Act). 
(c) FEDERAL DATABASES.—Internet links under 
subsection (b) shall include the following: 
(1) Links that provide information on how to 
enroll in a clinical trial referred to in subsection 
(b)(2)(B) and how to be treated under an outcomes- 
based treatment protocol referred to in such sub-
section. 
(2) Links to Federal electronic databases that 
are available to the public and provide disease-spe-
cific or condition-specific information, including such 
databases of the National Institutes of Health, the 
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Centers for Disease Control and Prevention, and the 
Food and Drug Administration. 
(3) A link to the Internet site under section 
204(a) (relating to research and treatments carried 
out pursuant to section 201, and the identity of the 
health care practitioners involved). 
(4) A link to the Internet site under section 
301 and the Internet site under section 485D(i) of 
the Public Health Service Act (as added by section 
302 of this Act). 
(d) DATE CERTAIN FOR OPERATION OF PROGRAM.— 
The Internet site under subsection (a) shall be established 
and ready for use by health care practitioners and lay per-
sons not later than two years after the date of the enact-
ment of this Act. 
TITLE II—PATIENT AND PRACTI-
TIONER RIGHTS REGARDING 
PRACTICE OF MEDICINE 
SEC. 201. PATIENT AND PRACTITIONER RIGHTS. 
(a) ACCESS TO MEDICAL TREATMENT.—If a patient 
of a qualifying practitioner chooses to use a drug or device 
offered by the practitioner as a treatment in the course 
of his or her professional practice, then notwithstanding 
the provisions of law specified in subsection (d), the practi-
tioner may in accordance with this title provide the treat-
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ment to the patient (and the patient may use the treat-
ment) without regard to whether the drug or device or 
use thereof is unapproved, including an unapproved drug 
or device that is made by the practitioner, except as pro-
vided in subsection (c). 
(b) ADDITIONAL
AUTHORITIES.—Notwithstanding 
the provisions of law specified in subsection (d), but sub-
ject to subsection (c), the following applies to a qualifying 
practitioner in the course of his or her professional prac-
tice: 
(1) The practitioner may for use in making a 
drug obtain active ingredients and other substances 
from sources other than approved drugs, including 
active ingredients in the form of bulk drugs. 
(2) The practitioner may make a new drug 
through providing instructions to a licensed phar-
macist. 
(3) A person may supply to the practitioner ac-
tive ingredients and other substances described in 
paragraph (1), and may pursuant to paragraph (2) 
supply such ingredients and substances to a phar-
macist. 
(4) A person may supply to the practitioner, 
and the practitioner may receive, an unapproved 
drug or an unapproved device that is approved for 
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commercial distribution in any of the following for-
eign countries: Australia, Canada, France, Germany, 
Holland, Japan, Sweden, and the United Kingdom. 
(5) The practitioner may otherwise introduce a 
drug or device into interstate commerce; deliver a 
drug or device for introduction into such commerce; 
transport a drug or device in such commerce; receive 
a drug or device in such commerce and deliver the 
drug or device; and hold a drug or device for sale 
after shipment of the drug or device in such com-
merce. 
(c) RESTRICTION REGARDING CERTAIN ACTIVE IN-
GREDIENTS.—The authority established in subsections (a) 
and (b) for a practitioner to make a drug applies only to 
the use of an active ingredient that— 
(1) is an ingredient in an approved drug; or 
(2) is an ingredient in an unapproved drug that 
is approved for commercial distribution in a foreign 
country specified in subsection (b)(4). 
(d) INAPPLICABILITY OF CERTAIN PROVISIONS OF 
FEDERAL, FOOD, DRUG, AND COSMETIC ACT.—For pur-
poses of subsections (a) and (b), the provisions of law 
specified in this subsection are section 351 of the Public 
Health Service Act and the following provisions of the 
Federal Food, Drug, and Cosmetic Act: sections 
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501(a)(2)(B) and 501(e) through 501(h); section 
502(f)(1); section 505; section 510; section 513; and sec-
tion 515. 
(e) LIMITATION.—Subsections (a) and (b) are subject 
to sections 202, 203, and 205, and to the definition of 
the term ‘‘drug’’ established in section 501(3). 
SEC. 202. GENERAL SAFEGUARDS. 
In the case of an activity under subsection (a) or (b) 
of section 201 that would in the absence of such sub-
section be a violation of the Federal Food, Drug, and Cos-
metic Act or section 351 of the Public Health Service Act, 
such subsection is effective with respect to a qualifying 
practitioner only if the following conditions are met: 
(1) Engaging in the activity is not a violation 
of the law of the State in which the activity is car-
ried out. 
(2) Before providing an unapproved treatment 
to a patient, such practitioner provides to the pa-
tient a statement in writing in accordance with this 
paragraph and obtains the signature of the patient 
on the statement as a declaration that the patient 
understands the statement and consents to receiving 
the treatment. The statement is in accordance with 
this paragraph if the following conditions are met: 
(A) The statement provides as follows: 
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(i) That the approval of the Food and 
Drug Administration has not been ob-
tained for the drug, device, or use involved, 
and that such Administration is the Fed-
eral agency whose mission is to protect the 
public health regarding drugs and devices. 
(ii) That the practitioner is not au-
thorized to provide the treatment without 
the clearance of the Secretary under sec-
tion 203 of this Act, but such clearance 
provides a lesser standard of protecting the 
public health than approval by the Food 
and Drug Administration under the provi-
sions of law otherwise applicable, and such 
clearance does not authorize the commer-
cial distribution of the treatment. 
(B) The statement identifies the health 
condition for which the treatment is to be pro-
vided to the patient, and provides the instruc-
tions that the practitioner expects the patient to 
follow with respect to the treatment. 
(C) The statement provides the opinion of 
the practitioner concerning the risks and bene-
fits of the treatment, including any expected 
possible side effects, and the statement de-
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scribes in general terms the standard of medical 
care for the health condition involved and ex-
plains the manner in which the treatment varies 
from such standard. 
(3) In the case of treatment with an unap-
proved drug or device made by the practitioner or 
obtained by the practitioner from another person, 
the practitioner does not in distributing the drug or 
device, other than to patients, impose a charge in ex-
cess of the amount necessary to recover the costs of 
making or obtaining, as applicable, the drug or de-
vice and providing for transporting the drug or de-
vice to other practitioners. This paragraph is subject 
to the definition of the term ‘‘drug’’ established in 
section 501(3). 
(4) The practitioner is not an employee or 
agent of any drug or device company, subject to sec-
tion 401(c)(2). 
(5) The practitioner does not, other than in 
communicating with the patients of the practitioner, 
advertise or promote the treatment. This paragraph 
does not with respect to the treatment prohibit pub-
lishing articles or letters in scientific or medical 
journals or publications; speaking or otherwise pro-
viding information at scientific conferences or meet-
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ings; or any other form of communicating with pro-
fessionals in scientific or medical fields. Except for 
the presentation of information to the public pursu-
ant to the program under section 204, this para-
graph does with respect to the treatment prohibit 
providing information in any manner typically used 
in the course of business to market products or serv-
ices to the general public. 
SEC. 
203. 
FEDERAL 
REGISTRATION 
OF 
UNAPPROVED 
TREATMENTS; DETERMINATION REGARDING 
SAFETY. 
(a) IN GENERAL.— 
(1) SUBMISSION
AND
CLEARANCE
OF
REG-
ISTRATION.—In the case of an unapproved treat-
ment whose provision to a patient under section 
201(a) would in the absence of such section be a vio-
lation of the Federal Food, Drug, and Cosmetic Act 
or section 351 of the Public Health Service Act, sec-
tion 201(a) is effective with respect to the provision 
of the treatment to the patient by a qualifying prac-
titioner only if the following conditions are met: 
(A) Before providing the treatment to the 
patient— 
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(i) such practitioner submitted to the 
Secretary a registration in accordance with 
subsection (b); and 
(ii) the Secretary made a determina-
tion that there is no clear and convincing 
evidence that the treatment is unsafe. 
(B) In the case of a registration that has 
been cleared, the practitioner submits to the 
Secretary supplemental notices in accordance 
with subsection (d). 
(2) ADMINISTRATION OF PROGRAM.—This sec-
tion shall be carried out by the Secretary acting 
through the Commissioner of Food and Drugs. The 
Secretary shall establish within the Food and Drug 
Administration an office or other administrative unit 
to carry out this section and section 204. 
(3) DEFINITIONS.—For purposes of this sec-
tion: 
(A) The term ‘‘clear’’, with respect to a 
registration under paragraph (1)(A), means a 
determination described in clause (ii) of such 
paragraph. 
(B) The term ‘‘disapprove’’, with respect 
to a registration under paragraph (1)(A), 
means a determination by the Secretary that 
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the treatment involved fails to meet the stand-
ard for clearance under clause (ii) of such para-
graph. 
(b) REGISTRATION REQUIREMENTS.—For purposes 
of subsection (a)(1)(A)(i), a registration under such sub-
section regarding a qualifying practitioner is in accordance 
with this subsection if the following conditions are met: 
(1) The registration provides the identity and 
business address of such practitioner and such infor-
mation regarding the medical licensing of the practi-
tioner in the State involved as the Secretary may re-
quire. 
(2) The registration describes the unapproved 
treatment involved and states that it is the intent of 
the practitioner to provide the treatment to one or 
more patients. 
(3) The registration contains all information 
that, under subparagraphs (B) and (C) of section 
202(2), is required to be provided to the patient in 
the statement under such section. 
(4) The registration contains such information 
regarding such treatment, and is accompanied by 
such samples and components regarding the treat-
ment, as the Secretary may require. 
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(5) The registration contains a statement au-
thorizing the Secretary to disclose, for purposes of 
the program under section 204, the identity of the 
practitioner, the business address of the practitioner, 
and information regarding the treatment. 
(c) DATE CERTAIN FOR FINAL AGENCY DETERMINA-
TION.— 
(1) IN GENERAL.—Not later than 90 days after 
the date on which a registration under subsection 
(a) is submitted to the Secretary in accordance with 
subsection (b), the Secretary shall clear the registra-
tion or disapprove clearance of the registration, and 
shall in writing provide to the qualifying practitioner 
who submitted the registration a statement of 
whether or not the registration has been cleared. If 
clearance was disapproved, the statement shall ex-
plain the reasons underlying the disapproval. 
(2) DEEMED CLEARANCE.— 
(A) NONCOMPLIANCE OF AGENCY REGARD-
ING
TIMEFRAME.—If the Secretary does not 
within the period of time specified in paragraph 
(1) clear a registration under subsection (a) or 
disapprove clearance of the registration, the 
registration is deemed to be cleared. 
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(B) REGISTRATION OF ADDITIONAL PRAC-
TITIONERS
PURSUANT
TO
PREVIOUSLY 
CLEARED
REGISTRATION.—If a registration 
submitted by a qualifying practitioner under 
subsection (a) is cleared, then in the case of the 
unapproved treatment involved, registrations 
submitted by other qualifying practitioners with 
respect to such treatment are upon submission 
in accordance with subsection (b) deemed to 
have been cleared. 
(d) SUPPLEMENTAL NOTICES.— 
(1) IN GENERAL.—For purposes of subsection 
(a)(1)(B), supplemental notices under such sub-
section are in accordance with this subsection if the 
following conditions are met: 
(A) The supplemental notices provide up-
dates of information provided in cleared reg-
istrations by providing such information on the 
effects on patients of the unapproved treat-
ments involved, including information on pa-
tient outcomes, as may be available to the 
qualifying practitioner involved. 
(B) The notices are submitted to the Sec-
retary at such intervals as may be specified by 
the Secretary, subject to paragraph (2). 
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(2) LIMITATION ON FREQUENCY OF NOTICES; 
EMERGENCY SITUATIONS.—The Secretary may not 
require submission of supplemental notices under 
subsection (a)(1)(B) more frequently than quarterly, 
except that the Secretary may establish such re-
quirements relating to supplemental notices on 
emergency situations as the Secretary determines to 
be appropriate. 
(e) CRITERIA.— 
(1) IN
GENERAL.—Not later than one year 
after the date of the enactment of this Act, the Sec-
retary shall by regulation issue criteria for carrying 
out this section. 
(2) STANDARD
FOR
CLEARANCE.—In estab-
lishing criteria under paragraph (1) regarding the 
standard 
for 
clearance 
under 
subsection 
(a)(1)(A)(ii), the Secretary is subject to the fol-
lowing: 
(A) In the case of an unapproved drug or 
an unapproved use of a drug, the criteria may 
not be as stringent as criteria for determining 
that the drug or use is safe for purposes of sec-
tion 505 of the Federal Food, Drug, and Cos-
metic Act or section 351 of the Public Health 
Service Act. 
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(B) In the case of an unapproved device or 
an unapproved use of a device, the criteria may 
not be as stringent as criteria under section 
513(a) of the Federal Food, Drug, and Cos-
metic Act for determining that there is a rea-
sonable assurance of the safety of a device. 
(C) The criteria shall provide for the re-
view of any relevant information published in 
scientific or medical journals. 
(D) The criteria may not require as a con-
dition of clearing a treatment that information 
relevant to the treatment has been published in 
one or more scientific or medical journals. 
(3) CONSIDERATION OF CAPACITY OF PRACTI-
TIONERS.—Criteria under paragraph (1) shall take 
into account the capacity of qualifying practitioners 
to comply with the criteria (as compared to the ca-
pacity of entities that submit applications under sec-
tion 505 or 515 of the Federal Food, Drug, and 
Cosmetic Act), and shall make reasonable efforts to 
avoid establishing criteria that would present a sig-
nificant disincentive for such practitioners to develop 
unapproved treatments. 
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SEC. 204. UNAPPROVED TREATMENTS; JOHN EISENBERG 
FORUM FOR FACILITATING EXCHANGE OF IN-
FORMATION IN SCIENTIFIC AND MEDICAL 
COMMUNITY. 
(a) IN GENERAL.—With respect to registrations 
cleared under section 203 and supplemental notices under 
such section regarding the registrations, the Secretary, 
acting through the Commissioner of Food and Drugs, 
shall (directly or through contract) establish a program 
in accordance with the following: 
(1) The Secretary shall maintain information 
from the registrations and notices and, subject to 
subsection (b), make the information available to sci-
entific and medical entities and the general public 
through establishing one or more Internet sites and 
posting the information on such site. 
(2) The Secretary shall post on the Internet 
site appropriate comments and information provided 
in response to the information placed on the site 
under paragraph (1). 
(3) The Secretary shall carry out paragraphs 
(1) and (2) in a manner reasonably calculated to 
provide a forum for obtaining and disseminating in-
formation, including clinical data, toward the fol-
lowing goals: 
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(A) Identifying new drugs and devices and 
uses of such drugs and devices that are reason-
able candidates for approval under section 505 
or 515 of the Federal Food, Drug, and Cos-
metic Act or under section 351 of the Public 
Health Service Act. 
(B) Identifying new drugs and devices and 
uses of such drugs and devices that constitute 
a threat to the public health. 
(C) Obtaining information for uses with re-
spect to promoting innovations in evidence- 
based clinical practice and health care tech-
nologies under title IX of the Public Health 
Service Act. 
(b) CERTAIN AUTHORITIES.—The posting by the 
Secretary of information on the Internet site under sub-
section (a) is subject to the following: 
(1) The Secretary shall post the identity and 
business address of qualifying practitioners with re-
spect to whom registrations under section 203 have 
been cleared. 
(2) In the case of an unapproved drug or an 
unapproved device made by a qualifying practitioner, 
the Secretary may not post information sufficient for 
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others to make the drug or device unless such prac-
titioner has in advance so authorized the Secretary. 
(3) The Secretary may impose reasonable re-
strictions on the format and volume of information 
to be posted and on the frequency of postings. 
(c) CLINICAL GUIDELINES.— 
(1) IN GENERAL.—With respect to a registra-
tion cleared under section 203, if the Secretary de-
termines that clinical data on the unapproved treat-
ment involved that has been submitted to the Sec-
retary pursuant to such section and this section may 
be sufficient to demonstrate that the treatment is 
safe, pure, and potent for purposes of section 351 of 
the Public Health Service Act (in the case of a bio-
logical product), or is safe and effective for purposes 
of section 505 of the Federal Food, Drug, and Cos-
metic Act (in the case of a new drug), or that there 
may be a reasonable assurance of the safety and ef-
fectiveness of the treatment for purposes of section 
515 of such Act (in the case of a device), then the 
Secretary— 
(A) shall develop, and publish on the Inter-
net site under subsection (a)(1), clinical guide-
lines on the treatment; and 
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(B) shall submit such guidelines to the 
Commissioner of Food and Drugs. 
(2) EFFECT
REGARDING
APPLICATIONS
TO 
FOOD AND DRUG ADMINISTRATION.—With respect to 
a biological product for which an application is sub-
mitted under section 351 of the Public Health Serv-
ice Act, or a new drug for which an application is 
submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act, or a device for which an 
application is submitted under section 515 of such 
Act, if clinical guidelines under paragraph (1) re-
garding such product, drug, or device (as the case 
may be) have been submitted to the Commissioner 
of Food and Drugs, then the following applies to the 
application: 
(A) If the clinical guidelines are submitted 
before the application, such Commissioner shall 
approve or disapprove the application not later 
than 120 days after the date on which the ap-
plication is submitted. 
(B) If the application is submitted before 
the clinical guidelines, such Commissioner shall 
approve or disapprove the application not later 
than 120 days after the date on which the clin-
ical guidelines are submitted. 
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(C) If the Commissioner disapproves the 
application, the Commissioner shall submit to 
the Secretary, not later than 30 days after the 
date of the disapproval, a report that provides 
the reasons underlying the disapproval. 
(3) NONCOMPLIANCE OF AGENCY REGARDING 
TIMEFRAME.—If the Commissioner of Food and 
Drugs does not within the period of time specified 
in paragraph (2) approve or disapprove an applica-
tion to which such paragraph applies, the application 
is deemed to be approved. 
(d) RULE OF CONSTRUCTION REGARDING SUPPLE-
MENTAL APPLICATIONS; CONSIDERATION
OF CLINICAL 
GUIDELINES.—In the case of a person who holds an ap-
proved application under section 351 of the Public Health 
Service Act or section 505 or 515 of the Federal Food, 
Drug, and Cosmetic Act, this section may not be con-
strued as having any legal effect with respect to the au-
thority to submit a supplemental application to seek ap-
proval of a change for the labeling of the product involved 
or the indications for use of the product, other than the 
legal effects of the timeframes under paragraph (2) of sub-
section (c) and the deeming of approval under paragraph 
(3) of such subsection, except that— 
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(1) clinical guidelines under paragraph (1) of 
such subsection may be considered by the Commis-
sioner of Food and Drugs in reviewing the supple-
mental application; and 
(2) such guidelines may, in the case of a drug 
with an approved application, be considered by the 
Commissioner for purposes of section 505A(c) of the 
Federal Food, Drug, and Cosmetic Act. 
(e) CRITERIA.—Not later than one year after the 
date of the enactment of this Act, the Secretary shall by 
regulation issue criteria for carrying out this section. 
SEC. 205. RELATION TO OTHER LAWS. 
(a) CONTROLLED SUBSTANCES ACT.—In the case of 
a controlled substance, the authority provided pursuant to 
section 201 for a qualifying practitioner with respect to 
a drug is subject to the compliance of the practitioner with 
each provision of the Controlled Substances Act that is 
applicable with respect to the drug. 
(b) STATE LAW.—This title does not supersede any 
law of a State or political subdivision of a State, including 
laws governing rights and duties among practitioners and 
patients. 
(c) OTHER PROVISIONS.—This Act does not have any 
legal effect on any of the following: 
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(1) Section 561 of the Federal Food, Drug, and 
Cosmetic Act (relating to expanded access to inves-
tigational drugs and devices). 
(2) With respect to an unapproved drug or de-
vice for which a qualifying practitioner is the origi-
nal maker, and with respect to an unapproved drug 
or device made by a manufacturer in a foreign coun-
try (in the case of a drug or device to which section 
201(b)(4) applies)— 
(A) agreements required by such maker as 
a condition of providing to a qualifying practi-
tioner a supply of the drug or device or instruc-
tions for making the drug or device; or 
(B) provisions regarding patents or related 
matters. 
SEC. 206. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—For the purpose of carrying out 
the functions under this title of the Commissioner of Food 
and Drugs (other than providing for Internet sites under 
section 204(a)(1) or approving an application, dis-
approving an application, or reporting on a disapproval 
pursuant to section 204(c)(2)), there are authorized to be 
appropriated such sums as may be necessary for each of 
the fiscal years 2008 through 2012. 
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(b) INTERNET SITES.—For the purpose of providing 
for Internet sites under section 204(a)(1), there are au-
thorized to be appropriated $50,000,000 for fiscal year 
2008, and such sums as may be necessary for each of the 
fiscal years 2009 through 2012. 
TITLE III—ADDITIONAL FORUMS 
FOR EXCHANGE OF HEALTH 
INFORMATION 
SEC. 301. JOHN EISENBERG FORUM REGARDING SURGICAL 
PROCEDURES. 
(a) IN GENERAL.—The Secretary, acting through the 
Commissioner of Food and Drugs, shall (directly or 
through contract) establish a program under which the 
following occur: 
(1) Health care practitioners submit to the Sec-
retary information obtained in the course of their 
professional practices regarding surgical procedures. 
(2) The Secretary maintains the information re-
ceived under paragraph (1); makes such information 
available to health care practitioners and the general 
public through one or more Internet sites; and re-
ceives, maintains, and makes available through such 
site appropriate comments and information provided 
in response to such information. 
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(3) The Secretary carries out paragraph (2) in 
a manner reasonably calculated to provide a forum 
for obtaining and disseminating information, includ-
ing clinical data, toward the following goals: 
(A) Identifying innovative surgical proce-
dures. 
(B) Identifying surgical procedures that 
constitute a threat to the public health. 
(C) Making available to the Secretary in-
formation for uses with respect to promoting in-
novations in evidence-based clinical practice and 
health care technologies under title IX of the 
Public Health Service Act. 
(b) VOLUNTARY
PARTICIPATION.—Subsection (a) 
may not be construed as requiring that any health care 
practitioner or other person participate in the program 
under such subsection. 
(c) CERTAIN AUTHORITIES.—The posting by the Sec-
retary of information on an Internet site under subsection 
(a) is subject to the following: 
(1) The Secretary may not post information 
submitted by a health care practitioner unless the 
practitioner authorizes the Secretary to include in 
the posting the identity and the business address of 
the practitioner. 
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(2) The Secretary may impose reasonable re-
strictions on the format and volume of information 
to be posted and on the frequency of postings. 
(d) CRITERIA.—Not later than one year after the 
date of the enactment of this Act, the Secretary shall by 
regulation issue criteria for carrying out this section. 
SEC. 302. JOHN EISENBERG FORUM REGARDING COM-
PLEMENTARY AND ALTERNATIVE MEDICINE; 
DIETARY SUPPLEMENTS AND FOOD. 
Section 485D of the Public Health Service Act is 
amended— 
(1) by redesignating subsections (i) and (j) as 
subsections (j) and (k), respectively; and 
(2) by adding after subsection (h) the following 
subsection: 
‘‘(i) JOHN EISENBERG FORUM FOR EXCHANGE OF 
INFORMATION.— 
‘‘(1) IN GENERAL.—The Director of the Center, 
in consultation with the Commissioner of Food and 
Drugs, shall (directly or through contract) establish 
a program under which the following occur: 
‘‘(A) Health care practitioners submit to 
the Director information obtained in the course 
of their professional practices regarding com-
plementary and alternative treatment, diag-
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TITLE V—GENERAL PROVISIONS 
SEC. 501. DEFINITIONS. 
For purposes of this Act: 
(1) Subject to the definition of the term ‘‘drug’’ 
established in paragraph (3), the term ‘‘approved’’, 
with respect to a new drug or a device, means a new 
drug or a device that is approved or cleared under 
section 505, 513, or 515 of the Federal Food, Drug, 
and Cosmetic Act, or under section 351 of the Pub-
lic Health Service Act. 
(2) The terms ‘‘device’’, ‘‘label’’, ‘‘labeling’’, 
‘‘new drug’’, and ‘‘State’’ have the meanings given 
such terms in section 201 of the Federal Food, 
Drug, and Cosmetic Act. 
(3) The term ‘‘drug’’ has the meaning given 
such term in section 201(g)(1) of the Federal Food, 
Drug, and Cosmetic Act, including provisions added 
by section 10(a) of the Dietary Supplement Health 
and Education Act of 1994 (Public Law 103–417; 
108 Stat. 4325, 4332) (relating to exceptions pro-
viding that dietary supplements, as defined in sec-
tion 201(ff) of the Federal Food, Drug, and Cos-
metic Act, are not drugs). Such definition applies to 
paragraph (1) of this section, to section 201(d), to 
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section 202(3), and to the other provisions of this 
Act. 
(4) The term ‘‘drug or device company’’ means 
an entity that— 
(A) has or has held an approved applica-
tion for a new drug under section 505 of the 
Federal Food, Drug, and Cosmetic Act or 
under section 351 of the Public Health Service 
Act, or an approved application for a device 
under section 515 of the Federal Food, Drug, 
and Cosmetic Act; 
(B) is the manufacturer of a device for 
which a regulation under subsection (d) or (e) 
of section 513 of the Federal Food, Drug, and 
Cosmetic Act has been promulgated, or for 
which an order under subsection (f) of such sec-
tion has been made; 
(C) is the maker of a drug or device that 
is approved for commercial distribution in a for-
eign country; or 
(D) is a commercial distributor of a drug 
or a device for an entity specified in subpara-
graph (A) or (B). 
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