I 
110TH CONGRESS 
1ST SESSION 
H. R. 788 
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
safety, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 31, 2007 
Mr. TIERNEY (for himself and Mr. RAMSTAD) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to drug safety, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Ad-
ministration Safety Act of 2007’’. 
SEC. 2. CENTER FOR POSTMARKET EVALUATION AND RE-
SEARCH FOR DRUGS AND BIOLOGICS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506C the following: 
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‘‘SEC. 507. DRUG SAFETY. 
‘‘(a) 
ESTABLISHMENT
OF
THE
CENTER
FOR 
POSTMARKET EVALUATION AND RESEARCH FOR DRUGS 
AND BIOLOGICS.—There is established within the Food 
and Drug Administration a Center for Postmarket Eval-
uation and Research for Drugs and Biologics (referred to 
in the section as the ‘Center’). The Director of the Center 
shall report directly to the Commissioner of Food and 
Drugs. 
‘‘(b) DUTIES OF THE CENTER FOR POSTMARKET 
EVALUATION
AND RESEARCH
FOR DRUGS
AND BIO-
LOGICS.— 
‘‘(1) RESPONSIBILITIES
OF
DIRECTOR.—The 
Director of the Center in consultation with the Di-
rector of the Center for Drug Evaluation and Re-
search or the Director of the Center for Biologics 
Evaluation and Research, as appropriate, shall— 
‘‘(A) conduct postmarket risk assessment 
of drugs approved under section 505 of this Act 
and of biological products licensed under section 
351 of the Public Health Service Act; 
‘‘(B) conduct and improve postmarket sur-
veillance of approved drugs and licensed biologi-
cal products using postmarket surveillance pro-
grams and activities (including Midwatch), risk- 
benefit analyses, adverse event reports, the sci-
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entific literature, any clinical or observational 
studies (including studies required under sub-
section (d) or (e)), and any other resources that 
the Director of the Center determines appro-
priate; 
‘‘(C) determine whether a study is required 
under subsection (d) or (e) and consult with the 
sponsors of drugs and biological products to en-
sure that such studies are completed by the 
date, and according to the terms, specified by 
the Director of the Center; 
‘‘(D) contract, or require the sponsor of an 
application or the holder of an approved appli-
cation or license to contract, with the holders of 
domestic and international patient databases to 
conduct epidemiologic and other observational 
studies; 
‘‘(E) determine, based on postmarket sur-
veillance programs and activities (including 
Midwatch), risk-benefit analyses, adverse event 
reports, the scientific literature, and any clinical 
or observational studies (including studies re-
quired under subsection (d) or (e)), and any 
other resources that the Director of the Center 
determines appropriate, whether a drug or bio-
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logical product may present an unreasonable 
risk to the health of patients or the general 
public, and take corrective action if such an un-
reasonable risk may exist; 
‘‘(F) make information about the safety 
and effectiveness of approved drugs and li-
censed biological products available to the pub-
lic and healthcare providers in a timely manner; 
and 
‘‘(G) conduct other activities as the Direc-
tor of the Center determines appropriate to en-
sure the safety and effectiveness of all drugs 
approved under section 505 and all biological 
products licensed under section 351 of the Pub-
lic Health Service Act. 
‘‘(2) 
DETERMINATION
OF
UNREASONABLE 
RISK.—In determining whether a drug or biological 
product may present an unreasonable risk to the 
health of patients or the general public, the Director 
of the Center in consultation with the Director of 
the Center for Drug Evaluation and Research or the 
Director of the Center for Biologic Evaluation and 
Research, as appropriate, shall consider the risk in 
relation to the known benefits of such drug or bio-
logical product. 
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‘‘(c) SECRETARIAL AUTHORITY.— 
‘‘(1) IN GENERAL.—Approval of a drug under 
section 505 of this Act or issuance of a license for 
a biological product under section 351 of the Public 
Health Service Act may be subject to the require-
ment that the sponsor conduct 1 or more postmarket 
studies as described in subsection (d) or (e) of this 
section, or other postmarket studies as required by 
the Secretary, to validate the safety and effective-
ness of the drug or biological product. 
‘‘(2) DEFINITION.—For purposes of this sec-
tion, the term ‘postmarket’ means— 
‘‘(A) with respect to a drug, after approval 
of an application under section 505; and 
‘‘(B) with respect to a biological product, 
after licensor under section 351 of the Public 
Health Service Act. 
‘‘(d) PREAPPROVAL REVIEW.— 
‘‘(1) REVIEW OF APPLICATION.— 
‘‘(A) IN GENERAL.— 
‘‘(I) REVIEW.—At any time before a 
drug is approved under section 505 of this 
Act or a biological product is licensed 
under section 351 of the Public Health 
Service Act, the Director of the Center 
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shall review the application (or supplement 
to the application), and any analyses asso-
ciated with the application, of such drug or 
biological product. 
‘‘(ii) EFFECT
OF
APPROVAL
OR
LI-
CENSOR.—The approval of a drug under 
section 505 or the licensor of a biological 
product under such section 351 shall not 
affect the continuation and completion of a 
review under clause (I). 
‘‘(B) LIMITATION.—In no case shall the 
review under subparagraph (A) delay a decision 
with respect to an application for a drug under 
section 505 of this Act or for a biological prod-
uct under section 351 of the Public Health 
Service Act. 
‘‘(2) RESULT OF REVIEW.—The Director of the 
Center may, based on the review under paragraph 
(1)— 
‘‘(A) require that the sponsor of the appli-
cation agree to conduct 1 or more postmarket 
studies to determine the safety or effectiveness 
of a drug or biological product, including such 
safety or effectiveness as compared to other 
drugs or biological products, to be completed by 
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a date, and according to the terms, specified by 
the Director of the Center; or 
‘‘(B) contract, or require the sponsor of 
the application to contract, with a holder of a 
domestic or an international patient database to 
conduct 1 or more epidemiologic or other obser-
vational studies. 
‘‘(e) POSTMARKETING STUDIES OF DRUG SAFETY.— 
‘‘(1) IN GENERAL.—At any time after a drug is 
approved under section 505 of this Act or a biologi-
cal product is licensed under section 351 of the Pub-
lic Health Service Act, the Director of the Center, 
may— 
‘‘(A) require that the holder of an ap-
proved application or license conduct 1 or more 
studies to determine the safety or effectiveness 
of such drug or biological product, including 
such safety and effectiveness as compared to 
other drugs or biological products, to be com-
pleted by a date, and according to the terms, 
specified by such Director; or 
‘‘(B) contract, or require the holder of the 
approved application or license to contract, with 
a holder of a domestic or an international pa-
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tient database to conduct 1 or more epidemio-
logic or other observational studies. 
‘‘(2) REVIEW OF OUTSTANDING STUDIES.—Not 
later than 90 days after the date of enactment of 
the Food and Drug Administration Safety Act of 
2007, the Director of the Center shall— 
‘‘(A) review and publish a list in the Fed-
eral Register of any postmarketing studies out-
standing on the date of enactment of the Food 
and Drug Administration Safety Act of 2007; 
and 
‘‘(B) as the Director determines appro-
priate, require the sponsor of a study described 
in subparagraph (A) to conduct such study 
under this subsection. 
‘‘(f) PUBLICATION
OF PROGRESS REPORTS
AND 
COMPLETED STUDIES.— 
‘‘(1) IN GENERAL.—The Director of the Center 
shall require that the sponsor of a study under sub-
section (d) or (e) submit to the Secretary— 
‘‘(A) not less frequently than every 90 
days, an up-to-date report describing the 
progress of such study; and 
‘‘(B) upon the completion date of such 
study, the results of such study. 
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‘‘(2) COMPLETION DATE.—For purposes of this 
section, the completion date of such study shall be 
determined by the Director of the Center. 
‘‘(g) DETERMINATIONS BY DIRECTOR.— 
‘‘(1) RESULTS OF STUDY.—The Director of the 
Center shall determine, upon receipt of the results of 
a study required under subsection (d) or (e)— 
‘‘(A) whether the drug or biological prod-
uct studied may present an unreasonable risk to 
the health of patients or the general public; and 
‘‘(B) what, if any, corrective action under 
subsection (k) shall be taken to protect patients 
and the public health. 
‘‘(2) RESULTS OF EVIDENCE.—The Director of 
the Center may, at any time, based on the empirical 
evidence from postmarket surveillance programs and 
activities (including MedWatch), risk-benefit anal-
yses, adverse event reports, the scientific literature, 
any clinical or observational studies (including stud-
ies required under subsection (d) or (e)), or any 
other resources that the Director of the Center de-
termines appropriate— 
‘‘(A) make a determination that a drug or 
biological product may present an unreasonable 
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risk to the health of patients or the general 
public; and 
‘‘(B) order a corrective action under sub-
section (k) be taken to protect patients and the 
public health. 
‘‘(3) REQUIRED CONSULTATION AND CONSIDER-
ATIONS.—Before making a determination under 
paragraph (2), ordering a study under subsection 
(d) or (e), or taking a corrective action under sub-
section (k), the Director of the Center shall— 
‘‘(A) consult with the Director of the Cen-
ter for Drug Evaluation and Research or the 
Director of the Center for Biologics Evaluation 
and Research, as appropriate; and 
‘‘(B) consider— 
‘‘(i) the benefit-to-risk profile of the 
drug or biological product; 
‘‘(ii) the effect that a corrective ac-
tion, or failure to take corrective action, 
will have on the patient population that re-
lies on the drug or biological product; and 
‘‘(iii) the extent to which the drug or 
biological product presents a meaningful 
therapeutic benefit as compared to other 
available treatments. 
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‘‘(h) PUBLIC INFORMATION.—Periodically, but not 
less often than every 90 days, the Secretary shall make 
available to the public, by publication in the Federal Reg-
ister and posting on an Internet website, the following in-
formation: 
‘‘(1) Studies required under subsection (d) or 
(e) including— 
‘‘(A) the type of study; 
‘‘(B) the nature of the study; 
‘‘(C) the primary and secondary outcomes 
of the study; 
‘‘(D) the date the study was required 
under subsection (d) or (e) or was agreed to by 
the sponsor; 
‘‘(E) the deadline for completion of the 
study; and 
‘‘(F) if the study has not been completed 
by the deadline under subparagraph (E), a 
statement that explains why. 
‘‘(2) The periodic progress reports and results 
of completed studies described under subsection (f). 
‘‘(3) Any determinations made by the Director 
of the Center under subsection (g), including— 
‘‘(A) reasons for the determination, includ-
ing factual basis for such determination; 
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‘‘(B) reference to supporting empirical 
data; and 
‘‘(C) an explanation that describes why 
contrary data is insufficient. 
‘‘(i) DRUG ADVISORY COMMITTEE.—The Drug Safe-
ty and Risk Management Drugs Advisory Committee with-
in the Center of the Food and Drug Administration 
shall— 
‘‘(1) meet not less frequently than every 180 
days; and 
‘‘(2) make recommendations to the Director of 
the Center with respect to— 
‘‘(A) which drugs and biological products 
should be the subject of a study under sub-
section (d) or (e); 
‘‘(B) the design and duration for studies 
under subsection (d) or (e); 
‘‘(C) which drugs and biological products 
may present an unreasonable risk to the health 
of patients or the general public; and 
‘‘(D) appropriate corrective actions under 
subsection (k). 
‘‘(j) PENALTIES.— 
‘‘(1) IN
GENERAL.—If the Secretary deter-
mines, after notice and opportunity for an informal 
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hearing, that a sponsor of a drug or biological prod-
uct or other entity has failed to complete a study re-
quired under subsection (d) or (e) by the date or to 
the terms specified by the Secretary under such sub-
section, the Secretary may order such sponsor or 
other entity to— 
‘‘(A) complete the study in a specified 
time; 
‘‘(B) revise the study to comply with the 
terms specified by the Secretary under sub-
section (d) or (e); or 
‘‘(C) pay a civil penalty. 
‘‘(2) AMOUNT OF PENALTIES.— 
‘‘(A) IN GENERAL.—The civil penalty or-
dered under paragraph (1) shall be $250,000 
for the first 30-day period after the date speci-
fied by the Secretary that the study is not com-
pleted, and shall double in amount for every 30- 
day period thereafter that the study is not com-
pleted. 
‘‘(B) LIMITATION.—In no case shall a pen-
alty under subparagraph (A) exceed $2,000,000 
for any 30-day period. 
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‘‘(3) NOTIFICATION
OF
PENALTY.—The Sec-
retary shall publish in the Federal Register any civil 
penalty ordered under this subsection. 
‘‘(k) RESULT OF DETERMINATION.— 
‘‘(1) IN GENERAL.—If the Director of the Cen-
ter makes a determination that a drug or biological 
product may present an unreasonable risk to the 
health of patients or the general public under sub-
section (g), such Director shall order a corrective ac-
tion, as described under paragraph (2). 
‘‘(2) CORRECTIVE ACTIONS.—The corrective ac-
tion described under subsection (g)— 
‘‘(A) may include— 
‘‘(i) requiring a change to the drug or 
biological product label by a date specified 
by the Director of the Center; 
‘‘(ii) modifying the approved indica-
tion of the drug or biological product to re-
strict use to certain patients; 
‘‘(iii) placing restriction on the dis-
tribution of the drug or biological product 
to ensure safe use; 
‘‘(iv) requiring the sponsor of the 
drug or biological product or license to es-
tablish a patient registry; 
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‘‘(v) requiring patients to sign a con-
sent form prior to receiving a prescription 
of the drug or biological product; 
‘‘(vi) requiring the sponsor to monitor 
sales and usage of the drug or biological 
product to detect unsafe use; 
‘‘(vii) requiring patient or physician 
education; and 
‘‘(viii) requiring the establishment of 
a risk management plan by the sponsor; 
and 
‘‘(B) shall include the requirements with 
respect to promotional material under sub-
section (l)(1). 
‘‘(3) PENALTIES.— 
‘‘(A) IN GENERAL.—If the Secretary deter-
mines, after notice and opportunity for an in-
formal hearing, that a sponsor of a drug or bio-
logical product has failed to take the corrective 
action ordered by the Director of the Center 
under this subsection or has failed to comply 
with subsection (l)(2), the Secretary may order 
such sponsor to pay a civil penalty. 
‘‘(B) AMOUNT OF PENALTIES.— 
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‘‘(i) IN GENERAL.—The civil penalty 
ordered under subparagraph (A) shall be 
$250,000 for the first 30-day period that 
the sponsor does not comply with the order 
under paragraph (1), and shall double in 
amount for every 30-day period thereafter 
that the order is not complied with. 
‘‘(ii) LIMITATION.—In no case shall a 
penalty under clause (i) exceed $2,000,000 
for any 30-day period. 
‘‘(C) NOTIFICATION
OF
PENALTY.—The 
Secretary shall publish in the Federal Register 
any civil penalty ordered under this paragraph. 
‘‘(l) PROMOTION MATERIAL.— 
‘‘(1) SAFETY
ISSUE.—If the Director of the 
Center makes a determination that a drug or bio-
logical product may present an unreasonable risk to 
the health of patients or the general public under 
subsection (g), such Director, in consultation with 
the Division of Drug Marketing, Advertising, and 
Communications of the Food and Drug Administra-
tion, shall— 
‘‘(A) notwithstanding section 502(n), re-
quire that the sponsor of such drug or biologi-
cal product submit to the Director of the Cen-
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ter copies of all promotional material with re-
spect to the drug or biological product not less 
than 30 days prior to the dissemination of such 
material; and 
‘‘(B) require that all promotional material 
with respect to the drug or biological product 
include certain disclosures, which shall be dis-
played prominently and in a manner easily un-
derstood by the general public, including— 
‘‘(i) a statement that describes the 
unreasonable risk to the health of patients 
or the general public as determined by the 
Director of the Center; 
‘‘(ii) a statement that encourages pa-
tients to discuss potential risks and bene-
fits with their healthcare provider; 
‘‘(iii) a description of the corrective 
actions required under subsection (k); 
‘‘(iv) where appropriate, a statement 
explaining that there may be products 
available to treat the same disease or con-
dition that present a more favorable ben-
efit-to-risk profile, and that patients should 
talk to their healthcare provider about the 
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risks and benefits of alternative treat-
ments; 
‘‘(v) a description of any requirements 
of outstanding clinical and observational 
studies, including the purpose of each 
study; and 
‘‘(vi) contact information to report a 
suspected adverse reaction. 
‘‘(2) NEW
PRODUCTS; OUTSTANDING
STUD-
IES.—For the first 2-year period after a drug is ap-
proved under section 505 of this Act or a biological 
product is licensed under section 351 of the Public 
Health Service Act, and with respect to drugs and 
biological products for which there are outstanding 
study requirements under subsection (d) or (e), the 
Director of the Center, in consultation with the Divi-
sion of Drug Marketing, Advertising, and Commu-
nications of the Food and Drug Administration, 
shall— 
‘‘(A) notwithstanding section 502(n), re-
quire that the sponsor of such drug or biologi-
cal product submit to the Director of the Cen-
ter copies of all promotional material with re-
spect to the drug or biological product not less 
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than 30 days prior to the dissemination of such 
material; and 
‘‘(B) require that all promotional material 
with respect to the drug or biological product 
include certain disclosures, which shall be dis-
played prominently and in a manner easily un-
derstood by the general public, including— 
‘‘(i) a statement explaining that the 
drug or biological product is newly ap-
proved or licensed or the subject of out-
standing clinical or observational studies, 
as the case may be, and, as a result, not 
all side effects or drug interactions may be 
known; 
‘‘(ii) the number of people in which 
the drug or biological product has been 
studied and the duration of time during 
which the drug or biological product has 
been studied; 
‘‘(iii) a statement that encourages pa-
tients to discuss the potential risks and 
benefits of treatment with their healthcare 
provider; 
‘‘(iv) a description of any require-
ments of outstanding clinical and observa-
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tional studies, including the purpose of 
each study; and 
‘‘(v) contact information to report a 
suspected adverse reaction. 
‘‘(3) EFFECT
OF
VOLUNTARY
SUBMISSION.— 
Paragraphs (1)(A) and (2)(A) shall not apply to the 
sponsor of a drug or biological product if such spon-
sor has voluntarily submitted to the Division of 
Drug Marketing, Advertising, and Communications 
of the Food and Drug Administration all pro-
motional material with respect to the drug or bio-
logical product prior to the dissemination of such 
material. 
‘‘(m) WITHDRAWAL OR SUSPENSION OF APPROVAL 
OR LICENSURE.— 
‘‘(1) IN GENERAL.—The Director of the Center, 
may withdraw or suspend approval of a drug or li-
censure of a biological product using expedited pro-
cedures (as prescribed by the Secretary in regula-
tions promulgated not later than 1 year after the 
date of enactment of the Food and Drug Adminis-
tration Safety Act of 2007, which shall include an 
opportunity for an informal hearing) after consulta-
tion with the Director of the Center for Drug Eval-
uation and Research or the Director of the Center 
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for Biologics Evaluation and Research, as appro-
priate, and any other person as determined appro-
priate by the Director of the Center, if— 
‘‘(A) the Director of the Center makes a 
determination that the drug or biological prod-
uct may present an unreasonable risk to the 
health of patients or the general public, and 
that risk cannot be satisfactorily alleviated by a 
corrective action under subsection (k); or 
‘‘(B) the sponsor fails to comply with an 
order or requirement under this section. 
‘‘(2) PUBLIC
INFORMATION.—The Secretary 
shall make available to the public, by publication in 
the Federal Register and posting on an Internet 
website, the details of the consultation described in 
paragraph (1), including— 
‘‘(A) the reason for the determination to 
withdraw, suspend, or failure to withdraw or 
suspend, approval for the drug or licensure for 
the biological product; 
‘‘(B) the factual basis for such determina-
tion; 
‘‘(C) reference to supporting empirical 
data; 
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‘‘(D) an explanation that describes why 
contrary data is insufficient; and 
‘‘(E) the position taken by each individual 
consulted. 
‘‘(n) EFFECT
OF SECTION.—The authorities con-
ferred by this section shall be separate from and in addi-
tion to the authorities conferred by section 505B. 
‘‘(o) ADMINISTRATION OF SECTION.—The provisions 
of this section shall be carried out by the Secretary, acting 
through the Director of the Center.’’. 
(b) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by inserting after subsection (j) the following: 
‘‘(k) If it is a drug or biological product for which 
the sponsor of an application or holder of an approved ap-
plication or license has not complied with an order or re-
quirement under section 507.’’. 
(c) REPORT ON DEVICES.—Not later than 6 months 
after the date of enactment of this Act, the Secretary of 
Health and Human Services, in consultation with the 
Commissioner of Food and Drugs, the Director of the 
Center for Postmarket Evaluation and Research for Drugs 
and Biologics, and the Director of the Center for Devices 
and Radiological Health, shall submit to Congress a report 
that— 
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(1) identifies gaps in the current process of 
postmarket surveillance of devices approved under 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq.); 
(2) includes recommendations on ways to im-
prove gaps in postmarket surveillance of devices; and 
(3) identifies the changes in authority needed to 
make those improvements, recognizing the legitimate 
differences between devices and other medical prod-
ucts regulated by the Food and Drug Administra-
tion. 
(d) TRANSFER OF FUNCTIONS.—The functions and 
duties of the Office of Surveillance and Epidemiology, in-
cluding the Drug Safety and Risk Management Drugs Ad-
visory Committee, of the Food and Drug Administration 
on the day before the date of enactment of this Act shall 
be transferred to the Center for Postmarket Evaluation 
and Research for Drugs and Biologics established under 
section 507 of the Federal Food, Drug, and Cosmetic Act 
(as added by this section). The Center for Postmarket 
Evaluation and Research for Drugs and Biologics shall be 
a separate entity within the Food and Drug Administra-
tion and shall not be an administrative office of the Center 
for Drug Evaluation and Research or the Center for Bio-
logics Evaluation and Research. 
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(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this Act 
(and the amendments made by this Act)— 
(1) $50,000,000 for fiscal year 2008; 
(2) $75,000,000 for fiscal year 2009; 
(3) $100,000,000 for fiscal year 2010; 
(4) $125,000,000 for fiscal year 2011; and 
(5) $150,000,000 for fiscal year 2012. 
Æ 
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