358 
counterfeit, diverted, subpotent, substandard, adul-
terated, misbranded, or expired drugs including bio-
logical products and active pharmaceutical ingredi-
ents from domestic and foreign sources. 
‘‘(2) ACTIVITIES.—The Secretary shall under-
take enhanced and joint enforcement activities with 
other Federal and State agencies, and establish re-
gional capacities for the validation of prescription 
drugs and the inspection of the prescription drug 
supply chain. 
‘‘(d) DEFINITION.—In this section, the term ‘pre-
scription drug’ means a drug subject to section 
503(b)(1).’’. 
SEC. 914. 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.— 
‘‘(A) 
DETERMINATION.—The 
Secretary 
shall not delay approval of a pending applica-
tion submitted under subsection (b)(2) or (j) 
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because of any request to take any form of ac-
tion relating to the application, either before or 
during consideration of the request, unless— 
‘‘(i) the request is in writing and is a 
petition submitted to the Secretary pursu-
ant to section 10.30 or 10.35 of title 21, 
Code of Federal Regulations (or any suc-
cessor regulations); and 
‘‘(ii) the Secretary determines, upon 
reviewing the petition, that a delay is nec-
essary to protect the public health. 
‘‘(B) NOTIFICATION.—If the Secretary de-
termines under subparagraph (A) that a delay 
is necessary with respect to an application, the 
Secretary shall provide to the applicant, not 
later than 30 days after making such deter-
mination, the following information: 
‘‘(i) Notification of the fact that a de-
termination under subparagraph (A) has 
been made. 
‘‘(ii) If applicable, any clarification or 
additional data that the applicant should 
submit to the docket on the petition to 
allow the Secretary to review the petition 
promptly. 
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‘‘(iii) A brief summary of the specific 
substantive issues raised in the petition 
which form the basis of the determination. 
‘‘(C) FORMAT.—The information described 
in subparagraph (B) shall be conveyed via ei-
ther, at the discretion of the Secretary— 
‘‘(i) a document; or 
‘‘(ii) a meeting with the applicant in-
volved. 
‘‘(D) PUBLIC DISCLOSURE.—Any informa-
tion conveyed by the Secretary under subpara-
graph (C) shall be considered part of the appli-
cation and shall be subject to the disclosure re-
quirements applicable to information in such 
application. 
‘‘(E) DENIAL
BASED
ON
INTENT
TO 
DELAY.—If the Secretary determines that a pe-
tition or a supplement to the petition was sub-
mitted with the primary purpose of delaying the 
approval of an application and the petition does 
not on its face raise valid scientific or regu-
latory issues, the Secretary may deny the peti-
tion at any point based on such determination. 
The Secretary may issue guidance to describe 
the factors that will be used to determine under 
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this subparagraph whether a petition is sub-
mitted with the primary purpose of delaying the 
approval of an application. 
‘‘(F) FINAL
AGENCY
ACTION.—The Sec-
retary shall take final agency action on a peti-
tion not later than 180 days after the date on 
which the petition is submitted. The Secretary 
shall not extend such period for any reason, in-
cluding— 
‘‘(i) any determination made under 
subparagraph (A); 
‘‘(ii) the submission of comments re-
lating to the petition or supplemental in-
formation supplied by the petitioner; or 
‘‘(iii) the consent of the petitioner. 
‘‘(G) EXTENSION OF 30-MONTH PERIOD.— 
If the filing of an application resulted in first- 
applicant 
status 
under 
subsection 
(j)(5)(D)(i)(IV) and approval of the application 
was delayed because of a petition, 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 petition and ending on the date of 
final agency action on the petition (inclusive of 
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such beginning and ending dates), without re-
gard to whether the Secretary grants, in whole 
or in part, or denies, in whole or in part, the 
petition. 
‘‘(H) 
CERTIFICATION.—The 
Secretary 
shall not consider a petition for review unless 
the party submitting such petition does so in 
written form and the subject document is 
signed and contains the following certification: 
‘I certify that, to my best knowledge and belief: 
(a) this petition includes all information and 
views upon which the petition relies; (b) this pe-
tition includes representative data and/or infor-
mation known to the petitioner which are unfa-
vorable to the petition; and (c) I have taken 
reasonable steps to ensure that any representa-
tive data and/or information which are unfavor-
able to the petition were disclosed to me. I fur-
ther certify that the information upon which I 
have based the action requested herein first be-
came known to the party on whose behalf this 
petition is submitted on or about the following 
date: llllllllll. If I received or 
expect to receive payments, including cash and 
other forms of consideration, to file this infor-
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mation or its contents, I received or expect to 
receive those payments from the following per-
sons 
or 
organizations: 
lllllllllllll. I verify under 
penalty of perjury that the foregoing is true 
and correct as of the date of the submission of 
this petition.’, with the date on which such in-
formation first became known to such party 
and the names of such persons or organizations 
inserted in the first and second blank space, re-
spectively. 
‘‘(I) VERIFICATION.—The Secretary shall 
not accept for review any supplemental informa-
tion or comments on a petition unless the party 
submitting such information or comments does 
so in written form and the subject document is 
signed and contains the following verification: ‘I 
certify that, to my best knowledge and belief: 
(a) I have not intentionally delayed submission 
of this document or its contents; and (b) the in-
formation upon which I have based the action 
requested herein first became known to me on 
or about llllllllll. If I received 
or expect to receive payments, including cash 
and other forms of consideration, to file this in-
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‘‘(B) DISMISSAL
OF
CERTAIN
CIVIL
AC-
TIONS.—If a civil action is filed against the 
Secretary with respect to any issue raised in the 
petition before the Secretary has taken final 
agency action on the petition within the mean-
ing of subparagraph (A), the court shall dismiss 
without prejudice the action for failure to ex-
haust administrative remedies. 
‘‘(C) ADMINISTRATIVE RECORD.—For pur-
poses of judicial review related to the approval 
of an application for which a petition under 
paragraph (1) was submitted, the administra-
tive record regarding any issue raised by the 
petition shall include— 
‘‘(i) the petition filed under paragraph 
(1) and any supplements and comments 
thereto; 
‘‘(ii) the Secretary’s response to such 
petition, if issued; and 
‘‘(iii) other information, as designated 
by the Secretary, related to the Secretary’s 
determinations regarding the issues raised 
in such petition, as long as the information 
was considered by the agency no later than 
the date of final agency action as defined 
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under subparagraph (2)(A), and regardless 
of whether the Secretary responded to the 
petition at or before the approval of the 
application at issue in the petition. 
‘‘(3) 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 that were 
approved during the preceding 12-month pe-
riod; 
‘‘(B) the number of such applications 
whose effective dates were delayed by petitions 
referred to in paragraph (1) during such period; 
‘‘(C) the number of days by which such ap-
plications were so delayed; and 
‘‘(D) the number of such petitions that 
were submitted during such period. 
‘‘(4) 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 and that seeks only to 
have the Secretary take or refrain from taking 
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any form of action with respect to that applica-
tion. 
‘‘(5) DEFINITIONS.— 
‘‘(A) APPLICATION.—For purposes of this 
subsection, the term ‘application’ means an ap-
plication submitted under subsection (b)(2) or 
(j). 
‘‘(B) PETITION.—For purposes of this 
subsection, other than paragraph (1)(A)(i), the 
term ‘petition’ means a request described in 
paragraph (1)(A)(i).’’. 
(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. 915. POSTMARKET DRUG SAFETY INFORMATION FOR 
PATIENTS AND PROVIDERS. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355), as amended by section 914(a), is 
amended by adding at the end the following: 
‘‘(r) POSTMARKET DRUG SAFETY INFORMATION FOR 
PATIENTS AND PROVIDERS.— 
‘‘(1) ESTABLISHMENT.—Not later than 1 year 
after the date of the enactment of the Food and 
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Drug Administration Amendments Act of 2007, the 
Secretary shall improve the transparency of informa-
tion about drugs and allow patients and health care 
providers better access to information about drugs 
by developing and maintaining an Internet Web site 
that— 
‘‘(A) provides links to drug safety informa-
tion listed in paragraph (2) for prescription 
drugs that are approved under this section or li-
censed under section 351 of the Public Health 
Service Act; and 
‘‘(B) improves communication of drug 
safety information to patients and providers. 
‘‘(2) INTERNET
WEB
SITE.—The Secretary 
shall carry out paragraph (1) by— 
‘‘(A) developing and maintaining an acces-
sible, consolidated Internet Web site with easily 
searchable drug safety information, including 
the information found on United States Govern-
ment Internet Web sites, such as the United 
States National Library of Medicine’s Daily 
Med and Medline Plus Web sites, in addition to 
other such Web sites maintained by the Sec-
retary; 
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‘‘(B) ensuring that the information pro-
vided on the Internet Web site is comprehensive 
and includes, when available and appropriate— 
‘‘(i) patient labeling and patient pack-
aging inserts; 
‘‘(ii) a link to a list of each drug, 
whether approved under this section or li-
censed under such section 351, for which 
a Medication Guide, as provided for under 
part 208 of title 21, Code of Federal Regu-
lations (or any successor regulations), is 
required; 
‘‘(iii) a link to the registry and results 
data bank provided for under subsections 
(i) and (j) of section 402 of the Public 
Health Service Act; 
‘‘(iv) the most recent safety informa-
tion and alerts issued by the Food and 
Drug Administration for drugs approved 
by the Secretary under this section, such 
as product recalls, warning letters, and im-
port alerts; 
‘‘(v) publicly available information 
about implemented RiskMAPs and risk 
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evaluation and mitigation strategies under 
subsection (o); 
‘‘(vi) guidance documents and regula-
tions related to drug safety; and 
‘‘(vii) other material determined ap-
propriate by the Secretary; 
‘‘(C) providing access to summaries of the 
assessed and aggregated data collected from the 
active surveillance infrastructure under sub-
section (k)(3) to provide information of known 
and serious side-effects for drugs approved 
under this section or licensed under such sec-
tion 351; 
‘‘(D) preparing, by 18 months after ap-
proval of a drug or after use of the drug by 
10,000 individuals, whichever is later, a sum-
mary analysis of the adverse drug reaction re-
ports received for the drug, including identifica-
tion of any new risks not previously identified, 
potential new risks, or known risks reported in 
unusual number; 
‘‘(E) enabling patients, providers, and 
drug sponsors to submit adverse event reports 
through the Internet Web site; 
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‘‘(F) providing educational materials for 
patients and providers about the appropriate 
means of disposing of expired, damaged, or un-
usable medications; and 
‘‘(G) supporting initiatives that the Sec-
retary determines to be useful to fulfill the pur-
poses of the Internet Web site. 
‘‘(3) POSTING OF DRUG LABELING.—The Sec-
retary shall post on the Internet Web site estab-
lished under paragraph (1) the approved profes-
sional labeling and any required patient labeling of 
a drug approved under this section or licensed under 
such section 351 not later than 21 days after the 
date the drug is approved or licensed, including in 
a supplemental application with respect to a labeling 
change. 
‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure 
development of the Internet Web site by the date de-
scribed in paragraph (1), the Secretary may, on a 
temporary or permanent basis, implement systems 
or products developed by private entities. 
‘‘(5) AUTHORITY FOR CONTRACTS.—The Sec-
retary may enter into contracts with public and pri-
vate entities to fulfill the requirements of this sub-
section. 
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‘‘(6) REVIEW.—The Advisory Committee on 
Risk Communication under section 567 shall, on a 
regular basis, perform a comprehensive review and 
evaluation of the types of risk communication infor-
mation provided on the Internet Web site established 
under paragraph (1) and, through other means, 
shall identify, clarify, and define the purposes and 
types of information available to facilitate the effi-
cient flow of information to patients and providers, 
and shall recommend ways for the Food and Drug 
Administration to work with outside entities to help 
facilitate the dispensing of risk communication infor-
mation to patients and providers.’’. 
SEC. 916. ACTION PACKAGE FOR APPROVAL. 
Section 505(l) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(l)) is amended by— 
(1) redesignating paragraphs (1), (2), (3), (4), 
and (5) as subparagraphs (A), (B), (C), (D), and 
(E), respectively; 
(2) striking ‘‘(l) Safety and’’ and inserting 
‘‘(l)(1) Safety and’’; and 
(3) adding at the end the following: 
‘‘(2) ACTION PACKAGE FOR APPROVAL.— 
‘‘(A) ACTION
PACKAGE.—The Secretary shall 
publish the action package for approval of an appli-
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cation under subsection (b) or section 351 of the 
Public Health Service Act on the Internet Web site 
of the Food and Drug Administration— 
‘‘(i) not later than 30 days after the date 
of approval of such application for a drug no 
active ingredient (including any ester or salt of 
the active ingredient) of which has been ap-
proved in any other application under this sec-
tion or section 351 of the Public Health Service 
Act; and 
‘‘(ii) not later than 30 days after the third 
request for such action package for approval re-
ceived under section 552 of title 5, United 
States Code, for any other drug. 
‘‘(B) IMMEDIATE
PUBLICATION
OF
SUMMARY 
REVIEW.—Notwithstanding subparagraph (A), the 
Secretary shall publish, on the Internet Web site of 
the Food and Drug Administration, the materials 
described in subparagraph (C)(iv) not later than 48 
hours after the date of approval of the drug, except 
where such materials require redaction by the Sec-
retary. 
‘‘(C) CONTENTS.—An action package for ap-
proval of an application under subparagraph (A) 
shall be dated and shall include the following: 
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‘‘(i) Documents generated by the Food and 
Drug Administration related to review of the 
application. 
‘‘(ii) Documents pertaining to the format 
and content of the application generated during 
drug development. 
‘‘(iii) Labeling submitted by the applicant. 
‘‘(iv) A summary review that documents 
conclusions from all reviewing disciplines about 
the drug, noting any critical issues and dis-
agreements with the applicant and within the 
review team and how they were resolved, rec-
ommendations for action, and an explanation of 
any nonconcurrence with review conclusions. 
‘‘(v) The Division Director and Office Di-
rector’s decision document which includes— 
‘‘(I) a brief statement of concurrence 
with the summary review; 
‘‘(II) a separate review or addendum 
to the review if disagreeing with the sum-
mary review; and 
‘‘(III) a separate review or addendum 
to the review to add further analysis. 
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‘‘(vi) Identification by name of each officer 
or employee of the Food and Drug Administra-
tion who— 
‘‘(I) participated in the decision to ap-
prove the application; and 
‘‘(II) consents to have his or her name 
included in the package. 
‘‘(D) REVIEW.—A scientific review of an appli-
cation is considered the work of the reviewer and 
shall not be altered by management or the reviewer 
once final. 
‘‘(E) 
CONFIDENTIAL
INFORMATION.—This 
paragraph does not authorize the disclosure of any 
trade secret, confidential commercial or financial in-
formation, or other matter listed in section 552(b) 
of title 5, United States Code.’’. 
SEC. 917. RISK COMMUNICATION. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as 
amended by section 603, is amended by adding at the end 
the following: 
‘‘SEC. 567. RISK COMMUNICATION. 
‘‘(a) ADVISORY COMMITTEE ON RISK COMMUNICA-
TION.— 
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‘‘(1) IN GENERAL.—The Secretary shall estab-
lish an advisory committee to be known as the ‘Advi-
sory Committee on Risk Communication’ (referred 
to in this section as the ‘Committee’). 
‘‘(2) DUTIES OF COMMITTEE.—The Committee 
shall advise the Commissioner on methods to effec-
tively communicate risks associated with the prod-
ucts regulated by the Food and Drug Administra-
tion. 
‘‘(3) MEMBERS.—The Secretary shall ensure 
that the Committee is composed of experts on risk 
communication, experts on the risks described in 
subsection (b), and representatives of patient, con-
sumer, and health professional organizations. 
‘‘(4) PERMANENCE
OF
COMMITTEE.—Section 
14 of the Federal Advisory Committee Act shall not 
apply to the Committee established under this sub-
section. 
‘‘(b) PARTNERSHIPS FOR RISK COMMUNICATION.— 
‘‘(1) IN GENERAL.—The Secretary shall partner 
with professional medical societies, medical schools, 
academic medical centers, and other stakeholders to 
develop robust and multi-faceted systems for com-
munication to health care providers about emerging 
postmarket drug risks. 
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‘‘(2) PARTNERSHIPS.—The systems developed 
under paragraph (1) shall— 
‘‘(A) account for the diversity among phy-
sicians in terms of practice, willingness to adopt 
technology, and medical specialty; and 
‘‘(B) include the use of existing commu-
nication channels, including electronic commu-
nications, in place at the Food and Drug Ad-
ministration.’’. 
SEC. 918. REFERRAL TO ADVISORY COMMITTEE. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 915, is further amended by 
adding at the end the following: 
‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—Prior to 
the approval of a drug no active ingredient (including any 
ester or salt of the active ingredient) of which has been 
approved in any other application under this section or 
section 351 of the Public Health Service Act, the Sec-
retary shall— 
‘‘(1) refer such drug to a Food and Drug Ad-
ministration advisory committee for review at a 
meeting of such advisory committee; or 
‘‘(2) if the Secretary does not refer such a drug 
to a Food and Drug Administration advisory com-
mittee prior to the approval of the drug, provide in 
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the action letter on the application for the drug a 
summary of the reasons why the Secretary did not 
refer the drug to an advisory committee prior to ap-
proval.’’. 
SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE. 
(a) IN GENERAL.—Not later than 1 year after the 
date of the enactment of this title, the Secretary shall 
issue a report responding to the 2006 report of the Insti-
tute of Medicine entitled ‘‘The Future of Drug Safety— 
Promoting and Protecting the Health of the Public’’. 
(b) CONTENT OF REPORT.—The report issued by the 
Secretary under subsection (a) shall include— 
(1) an update on the implementation by the 
Food and Drug Administration of its plan to re-
spond to the Institute of Medicine report described 
under such subsection; and 
(2) an assessment of how the Food and Drug 
Administration has implemented— 
(A) the recommendations described in such 
Institute of Medicine report; and 
(B) the requirement under section 505– 
1(c)(2) of the Federal Food, Drug, and Cos-
metic Act (as added by this title), that the ap-
propriate office responsible for reviewing a drug 
and the office responsible for postapproval safe-
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ty with respect to the drug work together to as-
sess, implement, and ensure compliance with 
the requirements of such section 505–1. 
SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355), as amended by section 918, is fur-
ther amended by adding at the end the following: 
‘‘(t) 
DATABASE
FOR
AUTHORIZED
GENERIC 
DRUGS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) PUBLICATION.—The Commissioner 
shall— 
‘‘(i) not later than 9 months after the 
date of the enactment of the Food and 
Drug Administration Amendments Act of 
2007, publish a complete list on the Inter-
net Web site of the Food and Drug Admin-
istration of all authorized generic drugs 
(including drug trade name, brand com-
pany manufacturer, and the date the au-
thorized generic drug entered the market); 
and 
‘‘(ii) update the list quarterly to in-
clude each authorized generic drug in-
cluded in an annual report submitted to 
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the Secretary by the sponsor of a listed 
drug during the preceding 3-month period. 
‘‘(B) NOTIFICATION.—The Commissioner 
shall notify relevant Federal agencies, including 
the Centers for Medicare & Medicaid Services 
and the Federal Trade Commission, when the 
Commissioner first publishes the information 
described in subparagraph (A) that the infor-
mation has been published and that the infor-
mation will be updated quarterly. 
‘‘(2) INCLUSION.—The Commissioner shall in-
clude in the list described in paragraph (1) each au-
thorized generic drug included in an annual report 
submitted to the Secretary by the sponsor of a listed 
drug after January 1, 1999. 
‘‘(3) AUTHORIZED
GENERIC
DRUG.—In this 
section, the term ‘authorized generic drug’ means a 
listed drug (as that term is used in subsection (j)) 
that— 
‘‘(A) has been approved under subsection 
(c); and 
‘‘(B) is marketed, sold, or distributed di-
rectly or indirectly to retail class of trade under 
a different labeling, packaging (other than re-
packaging as the listed drug in blister packs, 
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unit doses, or similar packaging for use in insti-
tutions), product code, labeler code, trade name, 
or trade mark than the listed drug.’’. 
SEC. 
921. 
ADVERSE 
DRUG 
REACTION 
REPORTS 
AND 
POSTMARKET SAFETY. 
Subsection (k) of section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355), as amended by 
section 905, is amended by adding at the end the fol-
lowing: 
‘‘(5) The Secretary shall— 
‘‘(A) conduct regular, bi-weekly screening 
of the Adverse Event Reporting System data-
base and post a quarterly report on the Adverse 
Event Reporting System Web site of any new 
safety information or potential signal of a seri-
ous risk identified by Adverse Event Reporting 
System within the last quarter; 
‘‘(B) report to Congress not later than 2 
year after the date of the enactment of the 
Food and Drug Administration Amendments 
Act of 2007 on procedures and processes of the 
Food and Drug Administration for addressing 
ongoing post market safety issues identified by 
the Office of Surveillance and Epidemiology and 
how recommendations of the Office of Surveil-
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