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 Improvement Act of 2010’’. 
SEC. 2. FEES PAID BY MANUFACTURERS TO FOOD AND 
DRUG ADMINISTRATION; DEPOSIT IN GEN-
ERAL FUND OF TREASURY; DIRECT SPEND-
ING. 
(a) IN GENERAL.—Subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379f et seq.) is amended by adding at the end the fol-
lowing part: 
‘‘PART 6—MODIFICATIONS REGARDING USER-FEE 
PROGRAMS 
‘‘SEC. 743. DEPOSIT OF FEES IN GENERAL FUND OF TREAS-
URY; DIRECT SPENDING. 
‘‘(a) DEPOSIT IN GENERAL FUND.—Notwithstanding 
any other provision of this Act related to the collection 
of fees related to drugs, devices, animal drugs, or generic 
animal drugs, all such fees collected under this Act shall 
be deposited in the general fund of the Treasury. 
‘‘(b) DIRECT SPENDING.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of this Act related to the collection of such 
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fees, amounts are available to the Secretary for obli-
gation in accordance with the following: 
‘‘(A) The amount authorized to be appro-
priated under section 736 for fees related to 
drugs is, to the extent described in section 
736(g)(2)(A)(ii) (as in effect on September 30, 
2010), available to the Secretary for obligation 
solely for the process for the review of human 
drug applications (within the meaning given to 
such term in section 735, as in effect on Sep-
tember 30, 2010). 
‘‘(B) The amount authorized to be appro-
priated under section 736A for fees relating to 
advisory review of prescription-drug television 
advertising is, to the extent described in section 
736A(g)(2)(A)(ii) (as in effect on September 
30, 2010), available to the Secretary for obliga-
tion solely for the process for the advisory re-
view of prescription drug advertising (within the 
meaning given to such terms in section 736A, 
as in effect on September 30, 2010). 
‘‘(C) The amount authorized to be appro-
priated under section 736A–1 for fees relating 
to the regulation of advertisements for drugs 
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and devices is available to the Secretary for ob-
ligation solely for such regulation. 
‘‘(D) The amount authorized to be appro-
priated under this Act for fees related to de-
vices is, to the extent described in section 
738(h)(2)(A)(ii) (as in effect on September 30, 
2010), available to the Secretary for obligation 
solely for the process for the review of device 
applications (within the meaning given to such 
terms in section 737, as in effect on September 
30, 2010). 
‘‘(E) The amount authorized to be appro-
priated under this Act for fees related to animal 
drugs is, to the extent described in section 
740(g)(2)(A)(ii) (as in effect on September 30, 
2010), available to the Secretary for obligation 
solely for the process for the review of animal 
drug applications (within the meaning given to 
such terms in section 739, as in effect on Sep-
tember 30, 2010). 
‘‘(F) The amount authorized to be appro-
priated under this Act for fees related to ge-
neric new animal drugs is, to the extent de-
scribed in section 741(g)(2)(A)(ii) (as in effect 
on September 30, 2010), available to the Sec-
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retary for obligation solely for the process for 
the review of abbreviated applications for ge-
neric new animal drugs (within the meanings 
given to such terms in section 741, as in effect 
on September 30, 2010). 
‘‘(2) LIST OF MANDATORY APPROPRIATIONS.— 
The program of spending established in paragraph 
(1) shall be considered entitlement authority within 
the meaning of section 250(c)(17) of the Balanced 
Budget and Emergency Deficit Control Act of 1985. 
‘‘SEC. 744. TERMINATION OF AUTHORITY FOR NEGOTIA-
TIONS WITH MANUFACTURERS ON USE OF 
FEES. 
‘‘(a) IN GENERAL.—With respect to persons from 
whom fees related to drugs, devices, animal drugs, or ge-
neric animal drugs are collected under this Act and not-
withstanding any other provision of this Act related to the 
collection of such fees: 
‘‘(1) On and after the date of the enactment of 
the Food and Drug Administration Improvement 
Act of 2010: 
‘‘(A) The Secretary may not enter into 
agreements with such persons on particular 
uses of the fees, including agreements on prior-
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ities, performance goals, or other commitments 
relating to— 
‘‘(i) review times for human drug ap-
plications or supplements (within the 
meaning given to such terms in section 
735, as in effect on September 30, 2010); 
‘‘(ii) review times for providing advi-
sory comments on direct-to-consumer tele-
vision advertisements (within the meaning 
given to such terms in section 736A, as in 
effect on September 30, 2010); 
‘‘(iii) review times for premarket ap-
plications, premarket reports, premarket 
notification submissions, or supplements 
(within the meaning given to such terms in 
section 737, as in effect on September 30, 
2010); 
‘‘(iv) review times for animal drug ap-
plications or supplements (within the 
meaning given to such terms in section 
739, as in effect on September 30, 2010); 
or 
‘‘(v) review times for abbreviated ap-
plications for a generic new animal drug or 
supplements thereto (within the meaning 
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given to such terms in section 741, as in 
effect on September 30, 2010). 
‘‘(B) The Secretary may not otherwise ne-
gotiate understandings with such persons on 
particular uses of the fees. 
‘‘(2) On and after October 1, 2010: 
‘‘(A) Any such agreement or under-
standing that was in effect on the day before 
the date of the Food and Drug Administration 
Improvement Act of 2010 is terminated, includ-
ing agreements or understandings pursuant to 
letters referred to in section 502(4) of Public 
Law 107–188 (116 Stat. 688), section 101(3) 
of Public Law 107–250 (116 Stat. 1589), sec-
tion 2(3) of Public Law 108–130 (117 Stat. 
1361), and section 101(c) of Public Law 110– 
85 (121 Stat. 823). 
‘‘(B) The Secretary is relieved of responsi-
bility for meeting any particular goals con-
cerning such review times that were established 
in such letters. 
‘‘(b) RULES
OF CONSTRUCTION.—Subsection (a) 
may not be construed— 
‘‘(1) as affecting the responsibility of the Sec-
retary to work toward the general goal of admin-
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istering this Act efficiently, including the review of 
applications, reports, supplements and other submis-
sions referred to in subsection (a)(1)(A); or 
‘‘(2) as terminating requirements for the collec-
tion of fees under any other provision of this Act.’’. 
(b) APPLICABILITY.—Section 743 of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a) of this section, applies with respect to fiscal year 2011 
and subsequent fiscal years. 
(c) MANAGEMENT STRATEGY TO ENSURE THE TIME-
LY REVIEW OF APPLICATIONS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this subsection referred to as 
the ‘‘Secretary’’) shall submit to the Committees on 
Appropriations and Energy and Commerce of the 
House of Representatives and the Committees on 
Appropriations and Health, Education, Labor, and 
Pensions of the Senate a comprehensive review of 
the drug and device application and amendment 
process to identify ways to increase efficiency, re-
duce paperwork, speed analysis, and promote the 
quickest possible decision process designed to ensure 
the entry of safe, effective drugs and devices into the 
marketplace. 
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(2) CONSIDERATIONS.—In carrying out the re-
view under paragraph (1), the Secretary shall con-
sider a time-and-motion study to identify best prac-
tices in processing applications and ensure the con-
sideration of safety issues. 
(3) STAFF-TO-APPLICATION
RATIO.—In car-
rying out the review under paragraph (1), not later 
than 180 days after the date of enactment of this 
Act, the Secretary shall submit to the committees re-
ferred to in such paragraph recommendations on an 
ideal staff-to-application ratio to address safety 
issues without slowing the decision process. 
SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET 
DRUG, DEVICE, AND BIOLOGIC SAFETY AND 
EFFECTIVENESS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505D the following: 
‘‘SEC. 505E. CENTER FOR POSTMARKET DRUG, DEVICE, AND 
BIOLOGIC SAFETY AND EFFECTIVENESS. 
‘‘(a) ESTABLISHMENT.—Not later than 180 days 
after the date of the enactment of the Food and Drug 
Administration Improvement Act of 2010, the Secretary 
shall establish within the Food and Drug Administration 
a center to be known as the Center for Postmarket Drug, 
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Device, and Biologic Safety and Effectiveness (referred to 
in this section as the ‘Center’), which shall be headed by 
a director appointed by the Commissioner of Food and 
Drugs in consultation with the Secretary (without regard 
to the delegation to the Commissioner under section 
1003(d)(2)). The Center shall be established as a separate 
center at the organizational level immediately below the 
Office of the Commissioner. The Director of the Center 
shall report directly to the Commissioner. 
‘‘(b) DUTIES.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Director of the Center shall have the principal 
responsibility within the Food and Drug Administra-
tion, below the Office of the Commissioner of Food 
and Drugs, for assisting the Commissioner in regu-
lating approved drugs and devices. Such assistance 
includes the following: 
‘‘(A) Monitoring approved drugs to deter-
mine whether there are any issues regarding 
safety or effectiveness. 
‘‘(B) Administering section 502 (relating 
to misbranding). 
‘‘(C) Establishing and administering re-
quirements for advertising under section 502(n) 
or 503(b). 
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‘‘(D) Administering requirements for stud-
ies and clinical trials that were required as con-
ditions for the approval of applications under 
section 505. 
‘‘(E) Withdrawing the approval of drugs 
under section 505(e). 
‘‘(F) Administering section 505(l)(2) (re-
lating to action packages for approval). 
‘‘(G) Establishing and administering re-
quirements for modifications in labeling under 
section 505(o)(4). 
‘‘(H) Administering authorities under sec-
tions 505(p) and 505–1 (relating to risk evalua-
tion and mitigation strategies). 
‘‘(I) Administering section 505(r) (relating 
to postmarket drug safety information for pa-
tients and providers). 
‘‘(2) EXCLUSION.—The responsibility vested in 
the Director of the Center does not include review 
of any request for approval, licensure, or clearance 
of a new active ingredient, new indication, new dos-
age form, new dosing regimen, new route of adminis-
tration, or any other new characteristic with respect 
to a previously approved, licensed, or cleared drug, 
biological product, or device. 
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‘‘(3) TRANSFERS.—Not later than 1 year after 
the date of the enactment of this section, the Sec-
retary shall transfer to the Center all responsibilities 
for the matters referred to in paragraph (1) that, on 
the day before the date of such transfer, were vested 
in the Center for Drug Evaluation and Research, the 
Center for Biologics Evaluation and Research, or the 
Center for Devices and Radiological Health Organi-
zation. 
‘‘(c) INTERACTIONS WITH OTHER CENTERS.— 
‘‘(1) CONSULTATION.—The Director of the 
Center shall carry out this section in consultation 
with the Directors of the Centers referred to in sub-
section (b)(3). 
‘‘(2) ACCESS TO INFORMATION.—The Secretary 
shall ensure that the Director of the Center has full 
access to all information possessed by the Food and 
Drug Administration that relates to the safety and 
effectiveness of approved drugs and devices, includ-
ing information possessed by the Centers referred to 
in subsection (b)(3). 
‘‘(d) DEFINITION.—For purposes of this section, the 
term ‘approved drugs and devices’ includes a drug for 
which an approved application under section 505 of this 
Act is in effect, a biological product for which a biologics 
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license under section 351 of the Public Health Service Act 
is in effect, or a device for which a clearance or approved 
application under section 510(k) or 515 of this Act is in 
effect. 
‘‘(e) FUNDING.—For the purpose of carrying out this 
section, the Secretary shall make available for a fiscal 
year, from the amount appropriated for the Food and 
Drug Administration for such year, the following amount, 
as applicable to such year: 
‘‘(1) For fiscal year 2011, $150,000,000. 
‘‘(2) For fiscal year 2012, $175,000,000. 
‘‘(3) For fiscal year 2013, $200,000,000. 
‘‘(4) For fiscal year 2014, $225,000,000. 
‘‘(5) For fiscal year 2015, $250,000,000.’’. 
SEC. 4. STATEMENT FOR INCLUSION IN DIRECT-TO-CON-
SUMER ADVERTISEMENTS OF DRUGS. 
(a) IN GENERAL.—Paragraph (3) of section 502(n) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352(n)) is amended by striking ‘‘published direct-to-con-
sumer advertisements’’ and inserting ‘‘published or tele-
vised direct-to-consumer advertisements’’. 
(b) EFFECTIVE DATE.—The requirements of section 
502(n)(3) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 352(n)(3)) applicable to televised direct-to-con-
sumer advertisements, as added by subsection (a), take 
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