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 
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 
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-
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 the drug or biological 
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-
cense of a biological product using expedited proce-
dures (as prescribed by the Secretary in regulations 
promulgated not later than 1 year after the date of 
enactment of the Food and Drug Administration 
Safety Act of 2005, which shall include an oppor-
tunity for an informal hearing) after consultation 
with the Director of Center for Drug Evaluation and 
Research or the Director of the Center for Biologics 
Evaluation and Research, as appropriate, and any 
other person as determined appropriate by the Di-
rector 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; 
‘‘(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 Drug Evaluation and Research, 
and the Director of the Center for Devices and Radio-
logical Health, shall submit to Congress a report that— 
(1) identifies deficiencies 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 deficiencies of postmarket surveillance of de-
vices; 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 Drug Safety, including the Drug 
Safety and Risk Management Drugs Advisory 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 Drug Evaluation and Research 
established under section 507 of the Federal Food, Drug, 
and Cosmetic Act (as added by this section). The Center 
for Postmarket Drug Evaluation and Research 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. 
(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 2006; 
(2) $75,000,000 for fiscal year 2007; 
(3) $100,000,000 for fiscal year 2008; 
(4) $125,000,000 for fiscal year 2009; and 
(5) $150,000,000 for fiscal year 2010. 
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