294 
SEC. 905. POSTMARKET RISK IDENTIFICATION AND ANAL-
YSIS SYSTEM FOR ACTIVE SURVEILLANCE 
AND ASSESSMENT. 
(a) FINDINGS.—Congress finds the following: 
(1) It is in the best interests of healthcare pro-
viders and patients that a postmarketing surveil-
lance system be developed that will enable active sur-
veillance of disparate sources of data to identify sig-
nals of unexpected adverse events and trends in the 
frequency of known adverse events, to provide data 
on the outcomes of off label uses, and to enable 
identification of safety issues earlier than can be 
done today. 
(2) Such a system can best be developed 
through public private partnerships to develop meth-
ods and tools for conducting surveillance using elec-
tronic databases that currently contain data on mil-
lions of patient encounters and are expected to grow 
significantly in the next decade, as well as electronic 
databases that contain millions of medical product 
purchases, health care claims, and similar informa-
tion relevant to product use, efficacy, and safety. 
(3) Therefore, this section directs the Secretary 
of Health and Human Services to enter into such 
public private partnerships as are necessary to de-
velop such a surveillance system and the tools and
295 
methods necessary to conduct active surveillance 
using the system. 
(b) DEVELOPMENT
OF
THE
POSTMARKET
RISK 
IDENTIFICATION AND ANALYSIS SYSTEM.—Subsection (k) 
of section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following: 
‘‘(3) The Secretary shall establish public private part-
nerships to develop tools and methods to enable the Sec-
retary and others to use available electronic databases to 
create a robust surveillance system that will support active 
surveillance on important drug safety questions including 
detecting and assessing drug safety signals; monitoring 
the frequency of known adverse events; and evaluating the 
outcomes of off label uses. Such surveillance shall provide 
for adverse event surveillance using the following data 
sources: 
‘‘(A) Federal health-related electronic data 
(such as data from the Medicare program and the 
health systems of the Department of Veterans Af-
fairs). 
‘‘(B) Private sector health-related electronic 
data (such as pharmaceutical purchase data and 
health insurance claims data).
296 
‘‘(C) Other information as the Secretary deems 
useful to create a robust system to identify and as-
sess adverse events and potential drug safety signals 
and to evaluate the extent and outcomes of off label 
uses of drugs. 
‘‘(4) Not later than 1 year after the date of the enact-
ment of this paragraph, the Secretary, in consultation 
with experts including individuals who are recognized in 
the field of data privacy and security, shall develop meth-
ods for integrating and analyzing safety data from mul-
tiple sources and mechanisms for obtaining access to such 
data. Such methods and mechanisms shall not compromise 
the protection of individually identifiable health informa-
tion. 
‘‘(5) Not later than 2 years after the date of the en-
actment of this paragraph, the Secretary shall have en-
tered into partnerships that will allow the analysis of avail-
able data from the various data sources using the stand-
ards and methods to identify drug safety signals and 
trends. Such analysis shall not disclose individually identi-
fiable health information when presenting such drug safe-
ty signals and trends or when responding to inquiries re-
garding such drug safety signals and trends. 
‘‘(6) Not later than 4 years after the date of the en-
actment of this paragraph, the Secretary shall report to
297 
the Congress on the ways in which the Secretary has used 
the surveillance system described in this subsection to 
identify specific drug safety signals and to better under-
stand the outcomes associated with drugs marketed in the 
United States. 
‘‘(7) Disclosure of individually identifiable informa-
tion is prohibited in the surveillance system described in 
this subsection. Nothing in this subsection prohibits lawful 
disclosure of such information for other purposes. 
‘‘(8) Nothing in this subsection shall be construed as 
limiting public health activities authorized under law.’’. 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out activities under the amendment made by subsection 
(b) for which funds are made available under section 736 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h), there are authorized to be appropriated, in addition 
to such funds, $25,000,000 for each of fiscal years 2008 
through 2012. 
(d) GAO REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comptroller 
General of the United States shall evaluate data confiden-
tiality and security issues relating to collection, trans-
mission, and maintenance of data for the surveillance sys-
tem developed pursuant to this section, and make rec-
ommendations to the Committee on Energy and Com-
298 
merce of the House of Representatives and the Committee 
on Health, Education, Labor and Pensions of the Senate, 
and any other congressional committees of relevant juris-
diction, regarding the need for any additional legislative 
or regulatory actions to ensure confidentiality and security 
of this data or otherwise address confidentiality and secu-
rity issues to ensure the effective operation of the surveil-
lance system. 
SEC. 907. STATEMENT FOR INCLUSION IN DIRECT-TO-CON-
SUMER ADVERTISEMENTS OF DRUGS. 
Section 502(n) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352), as amended by section 
901(d)(3), is further amended by striking ‘‘of this Act, 
except that’’ and inserting ‘‘of this Act, and in the case 
of any direct-to-consumer advertisement the following 
statement: ‘You are encouraged to report adverse effects 
of prescription drug medication to the FDA. Log onto 
www.fda.gov/medwatch or call 1–800-FDA-1088.’, except 
that’’. 
SEC. 908. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 510 the following:
299 
‘‘SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary, acting 
through the Commissioner of Food and Drugs, shall issue 
guidance for the conduct of clinical trials with respect to 
antibiotic drugs, including antimicrobials to treat acute 
bacterial sinusitis, acute bacterial otitis media, and acute 
bacterial exacerbation of chronic bronchitis. Such guide-
lines shall indicate the appropriate animal models of infec-
tion, in vitro techniques, and valid microbiologic surrogate 
markers. 
‘‘(b) REVIEW.—Not later than 5 years after the date 
of enactment of this section, the Secretary, acting through 
the Commissioner of Food and Drugs, shall review and 
update the guidance described under subsection (a) to re-
flect developments in scientific and medical information 
and technology.’’. 
SEC. 909. PROHIBITION AGAINST FOOD TO WHICH DRUGS 
OR 
BIOLOGICAL 
PRODUCTS 
HAVE 
BEEN 
ADDED. 
Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331), as amended by section 901(d)(2)(A), 
is amended by adding at the end the following:
300 
‘‘(kk) The introduction or delivery for introduction 
into interstate commerce of any food to which has been 
added— 
‘‘(1) a drug approved under section 505, 
‘‘(2) a biological product licensed under section 
351 of the Public Health Service Act, or 
‘‘(3) a drug or biological product for which sub-
stantial clinical investigations have been instituted 
and for which the existence of such investigations 
has been made public, 
unless such drug or biological product was marketed in 
food before any approval of the drug under section 505 
of this Act, before licensure of the biological product under 
section 351 of the Public Health Service Act, and before 
any substantial clinical investigations involving the drug 
or biological product have been instituted, or unless the 
Secretary, in the Secretary’s discretion, has issued a regu-
lation, after notice and comment, approving the addition 
of such drug or biological product to the food.’’. 
SEC. 910. ASSURING PHARMACEUTICAL SAFETY. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505B the following:
301 
‘‘SEC. 505C. PHARMACEUTICAL SECURITY. 
‘‘(a) IN GENERAL.—The Secretary shall develop 
standards and identify and validate effective technologies 
for the purpose of securing the prescription drug distribu-
tion system against counterfeit, diverted, subpotent, sub-
standard, adulterated, misbranded, or expired drugs. 
‘‘(b) STANDARDS DEVELOPMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall, in con-
sultation with the agencies specified in paragraph 
(3), prioritize and develop standards for the identi-
fication, validation, authentication, and tracking of 
prescription drugs. 
‘‘(2) PROMISING TECHNOLOGIES.—The stand-
ards developed under this subsection shall address 
promising technologies, including— 
‘‘(A) radio frequency identification tech-
nology; 
‘‘(B) nanotechnology; 
‘‘(C) encryption technologies; and 
‘‘(D) other track-and-trace technologies. 
‘‘(3) INTERAGENCY COLLABORATION.—In car-
rying out this subsection, the Secretary shall consult 
with Federal health and security agencies, includ-
ing— 
‘‘(A) the Administrator of the Drug En-
forcement Administration;
302 
‘‘(B) the Secretary of the Department of 
Homeland Security; 
‘‘(C) the Secretary of Commerce; and 
‘‘(D) other appropriate Federal and State 
agencies. 
‘‘(c) INSPECTION AND ENFORCEMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall expand 
and enhance the resources and facilities of the Office 
of Regulatory Affairs of the Food and Drug Admin-
istration to protect the prescription drug distribution 
system against counterfeit, diverted, subpotent, sub-
standard, adulterated, misbranded, or expired drugs. 
‘‘(2) ACTIVITIES.—The Secretary shall under-
take enhanced and joint enforcement activities with 
other Federal agencies and State officials, and es-
tablish regional capacities for the validation of pre-
scription drugs and the inspection of the prescrip-
tion drug distribution system. 
‘‘(d) DEFINITION.—In this section, the term ‘pre-
scription drug’ means a drug subject to section 
503(b)(1).’’. 
SEC. 911. ORPHAN ANTIBIOTIC DRUGS. 
(a) PUBLIC MEETING.—The Commissioner of Food 
and Drugs shall convene a public meeting regarding which 
serious and life threatening infectious diseases, such as
303 
diseases due to gram-negative bacteria and other diseases 
due to antibiotic-resistant bacteria, potentially qualify for 
available grants and contracts under section 5(a) of the 
Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives 
for development. 
(b) GRANTS AND CONTRACTS FOR THE DEVELOP-
MENT OF ORPHAN DRUGS.—Section 5(c) of the Orphan 
Drug Act (21 U.S.C. 360ee(c)) is amended to read as fol-
lows: 
‘‘(c) For grants and contracts under subsection (a), 
there is authorized to be appropriated $30,000,000 for 
each of fiscal years 2008 through 2012.’’. 
SEC. 912. CITIZEN PETITIONS AND PETITIONS FOR STAY OF 
AGENCY ACTION. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355), as amended by 
section 901(a), is amended by adding at the end the fol-
lowing: 
‘‘(q) PETITIONS AND CIVIL ACTIONS REGARDING AP-
PROVAL OF CERTAIN APPLICATIONS.— 
‘‘(1) IN GENERAL.—With respect to a pending 
application under subsection (b)(2) or (j), if a peti-
tion is submitted to the Secretary that seeks to have 
the Secretary take, or refrain from taking, any form 
of action relating to the approval of the application,
304 
including a delay in the effective date of the applica-
tion, the following applies, subject to paragraph (5): 
‘‘(A) The Secretary may not, on the basis 
of the petition, delay approval of the application 
unless the Secretary determines that a delay is 
necessary to protect the public health and pro-
vides the applicant with a written explanation 
of the reasons for the delay. Consideration of a 
petition shall be separate and apart from the 
review and approval of the application. 
‘‘(B) The Secretary shall take final agency 
action on the petition not later than 180 days 
after the date on which the petition is sub-
mitted. The Secretary shall not extend such pe-
riod, even with the consent of the petitioner, for 
any reason, including based upon the submis-
sion of comments relating to the petition or 
supplemental information supplied by the peti-
tioner. 
‘‘(C) If the Secretary determines that the 
petition was submitted with the primary pur-
pose of delaying approval of a drug under sub-
section (b)(2) or (j), the Secretary may deny 
the petition at any point.
305 
‘‘(D) If the filing of the application re-
sulted in first-applicant status under subsection 
(j)(5)(D)(i)(IV), the 30-month period under 
such subsection is deemed to be extended by a 
period of time equal to the period beginning on 
the date on which the Secretary received the pe-
tition and ending on the date of final agency 
action on the petition (inclusive of such begin-
ning and ending dates), without regard to 
whether the Secretary grants, in whole or in 
part, or denies, in whole or in part, the petition. 
‘‘(E) The Secretary may not consider the 
petition for review unless it is signed and con-
tains the following certification: ‘I certify that, 
to my best knowledge and belief: (a) this peti-
tion includes all information and views upon 
which the petition relies; (b) this petition in-
cludes representative data and/or information 
known to the petitioner which are unfavorable 
to the petition; and (c) I have taken reasonable 
steps to ensure that any representative data 
and/or information which are unfavorable to the 
petition were disclosed to me. I further certify 
that the information upon which I have based 
the action requested herein first became known
306 
to the party on whose behalf this petition is 
submitted on or about the following date: 
llllllllll. I received or expect to 
receive payments, including cash and other 
forms of consideration, from the following per-
sons or organizations to file this petition: 
lllllllllllll. I verify under 
penalty of perjury that the foregoing is true 
and correct.’. 
‘‘(2) EXHAUSTION
OF
ADMINISTRATIVE
REM-
EDIES.— 
‘‘(A) FINAL AGENCY ACTION WITHIN 180 
DAYS.—The Secretary shall be considered to 
have taken final agency action on a petition re-
ferred to in paragraph (1) if— 
‘‘(i) during the 180-day period re-
ferred to in subparagraph (B) of such 
paragraph, the Secretary makes a final de-
cision within the meaning of section 
10.45(d) of title 21, Code of Federal Regu-
lations (or any successor regulation); or 
‘‘(ii) such period expires without the 
Secretary having made such a final deci-
sion.
307 
‘‘(B) DISMISSAL
OF
CERTAIN
CIVIL
AC-
TIONS.—If a civil action is filed with respect to 
any issue raised in a petition under paragraph 
(1) before the Secretary has taken final agency 
action on the petition within the meaning of 
subparagraph (A), the court shall dismiss the 
action for failure to exhaust administrative rem-
edies. 
‘‘(3) APPLICABILITY
OF
CERTAIN
REGULA-
TIONS.—The provisions of this section are in addi-
tion to the requirements for the submission of a pe-
tition to the Secretary that apply under section 
10.30 or 10.35 of title 21, Code of Federal Regula-
tions (or any successor regulations). 
‘‘(4) ANNUAL REPORT ON DELAYS IN APPROV-
ALS PER PETITIONS.—The Secretary shall annually 
submit to the Congress a report that specifies— 
‘‘(A) the number of applications under 
subsections (b)(2) and (j) that were approved 
during the preceding 12-month period; 
‘‘(B) the number of such applications 
whose effective dates were delayed by petitions 
referred to in paragraph (1) during such period; 
and
308 
‘‘(C) the number of days by which the ap-
plications were so delayed. 
‘‘(5) EXCEPTIONS.—This subsection does not 
apply to— 
‘‘(A) a petition that relates solely to the 
timing of the approval of an application pursu-
ant to subsection (j)(5)(B)(iv); or 
‘‘(B) a petition that is made by the spon-
sor of an application under subsection (b)(2) or 
(j) and that seeks only to have the Secretary 
take or refrain from taking any form of action 
with respect to that application. 
‘‘(6) DEFINITION.—For purposes of this sub-
section, the term ‘petition’ includes any request to 
the Secretary for an action described in paragraph 
(1), without regard to whether the request is charac-
terized as a petition.’’. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit a report to the Congress on 
ways to encourage the early submission of petitions under 
section 505(q), as added by subsection (a). 
SEC. 913. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—For carrying out this title and the 
amendments made by this title, there is authorized to be
309 
appropriated $25,000,000 for each of fiscal years 2008 
through 2012. 
(b) RELATION TO OTHER FUNDING.—The authoriza-
tion of appropriations under subsection (a) is in addition 
to any other funds available for carrying out this title and 
the amendments made by this title. 
SEC. 914. EFFECTIVE DATE AND APPLICABILITY. 
(a) EFFECTIVE DATE.—This title takes effect 180 
days after the date of the enactment of this Act. 
(b) DRUGS DEEMED TO HAVE RISK EVALUATION 
AND MITIGATION STRATEGIES.— 
(1) IN GENERAL.—A drug that was approved 
before the effective date of this Act is, in accordance 
with paragraph (2), deemed to have in effect an ap-
proved risk evaluation and mitigation strategy under 
section 505–1 of the Federal Food, Drug, and Cos-
metic Act (as added by section 901 of this title) (re-
ferred to in this section as the ‘‘Act’’ ) if there are 
in effect on the effective date of this Act restrictions 
on distribution or use— 
(A) required under section 314.520 or sec-
tion 601.42 of title 21, Code of Federal Regula-
tions; or 
(B) otherwise agreed to by the applicant 
and the Secretary for such drug.
310 
(2) 
ELEMENTS
OF
STRATEGY; 
ENFORCE-
MENT.—The approved risk evaluation and mitigation 
strategy in effect for a drug under paragraph (1)— 
(A) is deemed to consist of the elements 
described in paragraphs (1) and (2) of section 
505–1(d) of the Act and any additional ele-
ments under subsections (d) and (e) of such 
section in effect for such drug on the effective 
date of this Act; and 
(B) is subject to enforcement by the Sec-
retary to the same extent as any other risk 
evaluation and mitigation strategy under sec-
tion 505–1 of the Act. 
(3) SUBMISSION.—Not later than 180 days 
after the effective date of this Act, the holder of an 
approved application for which a risk evaluation and 
mitigation strategy is deemed to be in effect under 
paragraph (1) shall submit to the Secretary a pro-
posed risk evaluation and mitigation strategy. Such 
proposed strategy is subject to section 505–1 of the 
Act as if included in such application at the time of 
submission of the application to the Secretary. 
(c) OTHER DRUGS APPROVED BEFORE THE EFFEC-
TIVE DATE.—The Secretary, on a case-by-case basis, may 
require the holder of an application approved before the
311 
effective date of this Act to which subsection (b) does not 
apply to submit a proposed risk evaluation and mitigation 
strategy in accordance with the timeframes provided for 
in subparagraphs (C) through (D) of section 505–1(g)(2) 
of the Act if the Secretary determines (with respect to 
such drug or with respect to the group of drugs to which 
such drug belongs) that— 
(1) an element described under section 505– 
1(d)(1) of the Act may require modification; or 
(2) a standard for adding an element described 
in subsection (e) or (d) of section 505–1 of the Act 
that is not in effect with respect to such drug or 
class of drugs may apply. 
(d) USE OF ADVISORY COMMITTEES; PROCESS FOR 
ADDRESSING DRUG CLASS EFFECTS.—In imposing a re-
quirement under subsection (c), the Secretary— 
(1) may convene a meeting of 1 or more advi-
sory committees of the Food and Drug Administra-
tion in accordance with paragraph (6) of section 
505–1(h) of the Act; and
312 
(2) may use the process described in paragraph 
(7) of such section 505–1(h) (relating to addressing 
drug class effects). 
Passed the House of Representatives July 11, 2007. 
Attest: 
Clerk.
110TH CONGRESS 
1ST SESSION 
H. R. 2900 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs 
for prescription drugs and for medical devices, to 
enhance the postmarket authorities of the Food 
and Drug Administration with respect to the 
safety of drugs, and for other purposes.