1.This Act may be cited as the
Food and Drug Administration
Improvement Act of 2010
.
2.Fees paid by
manufacturers to Food and Drug Administration; deposit in general fund of
Treasury; direct spending
(a)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 following part:
6Modifications
regarding user-fee programs
743.Deposit of fees
in general fund of Treasury; direct spending
(a)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)
(1)Notwithstanding any
other provision of this Act related to the collection of such fees, amounts are
available to the Secretary for obligation in accordance with the
following:
(A)The amount authorized to be appropriated
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 September 30, 2010).
(B)The amount
authorized to be appropriated 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 obligation solely for the process for the advisory review 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 appropriated
under section 736A–1 for fees relating to the regulation of advertisements for
drugs and devices is available to the Secretary for obligation solely for such
regulation.
(D)The amount authorized to be appropriated
under this Act for fees related to devices 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 appropriated
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 September 30, 2010).
(F)The amount
authorized to be appropriated under this Act for fees related to generic new
animal drugs is, to the extent described in section 741(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 abbreviated applications for generic new
animal drugs (within the meanings given to such terms in section 741, as in
effect on September 30, 2010).
(2)List of
mandatory appropriationsThe
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.
744.Termination of
authority for negotiations with manufacturers on use of fees
(a)With respect to
persons from whom fees related to drugs, devices, animal drugs, or generic
animal drugs are collected under this Act and notwithstanding 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 priorities, performance goals, or other commitments
relating to—
(i)review times for
human drug applications or supplements (within the meaning given to such terms
in section 735, as in effect on September 30, 2010);
(ii)review times for
providing advisory comments on direct-to-consumer television advertisements
(within the meaning given to such terms in section 736A, as in effect on
September 30, 2010);
(iii)review times for premarket applications,
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 applications 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 applications for a generic new animal drug or supplements thereto
(within the meaning given to such terms in section 741, as in effect on
September 30, 2010).
(B)The Secretary may
not otherwise negotiate understandings with such persons on particular uses of
the fees.
(2)On and after October 1, 2010:
(A)Any such agreement
or understanding that was in effect on the day before the date of the Food and
Drug Administration Improvement Act of 2010 is terminated, including 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), section 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 responsibility for meeting any particular goals concerning such
review times that were established in such letters.
(b)Subsection (a) may not be construed—
(1)as affecting the
responsibility of the Secretary to work toward the general goal of
administering this Act efficiently, including the review of applications,
reports, supplements and other submissions referred to in subsection (a)(1)(A);
or
(2)as terminating requirements for the
collection of fees under any other provision of this
Act.
.
(b)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 timely review of applications
(1)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,
reduce paperwork, speed analysis, and promote the quickest possible decision
process designed to ensure the entry of safe, effective drugs and devices into
the marketplace.
(2)In
carrying out the review under paragraph (1), the Secretary shall consider a
time-and-motion study to identify best practices in processing applications and
ensure the consideration of safety issues.
(3)Staff-to-application
ratioIn carrying 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 referred to in such paragraph recommendations on an
ideal staff-to-application ratio to address safety issues without slowing the
decision process.
3.Establishment of
Center for Postmarket Drug, Device, and Biologic Safety and
EffectivenessChapter 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:
505E.Center for
Postmarket Drug, Device, and Biologic Safety and Effectiveness
(a)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, 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)
(1)Subject to paragraph
(2), the Director of the Center shall have the principal responsibility within
the Food and Drug Administration, below the Office of the Commissioner of Food
and Drugs, for assisting the Commissioner in regulating approved drugs and
devices. Such assistance includes the following:
(A)Monitoring
approved drugs to determine whether there are any issues regarding safety or
effectiveness.
(B)Administering
section 502 (relating to misbranding).
(C)Establishing and administering requirements
for advertising under section 502(n) or 503(b).
(D)Administering
requirements for studies and clinical trials that were required as conditions
for the approval of applications under section 505.
(E)Withdrawing the approval of drugs under
section 505(e).
(F)Administering
section 505(l)(2) (relating to action packages for approval).
(G)Establishing and administering requirements
for modifications in labeling under section 505(o)(4).
(H)Administering
authorities under sections 505(p) and 505–1 (relating to risk evaluation and
mitigation strategies).
(I)Administering section 505(r) (relating to
postmarket drug safety information for patients and providers).
(2)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 dosage form, new dosing regimen, new route of
administration, or any other new characteristic with respect to a previously
approved, licensed, or cleared drug, biological product, or device.
(3)Not later than 1 year after the date of the
enactment of this section, the Secretary 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 Organization.
(c)Interactions
with other centers
(1)The
Director of the Center shall carry out this section in consultation with the
Directors of the Centers referred to in subsection (b)(3).
(2)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, including information possessed by the Centers referred to in
subsection (b)(3).
(d)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 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)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.
.
4.Statement for
inclusion in direct-to-consumer advertisements of drugs
(a)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-consumer
advertisements
and inserting published or televised
direct-to-consumer advertisements
.
(b)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-consumer advertisements, as added
by subsection (a), take effect on the date that is 180 days after the date of
the enactment of this Act.
(c)Not later than the date that is 180 days
after the date of the enactment of this Act, the Secretary of Health and Human
Services shall promulgate final regulations to implement such
requirements.
5.Liability under
State and local requirements respecting devices
(a)Section
521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by
adding at the end the following:
(c)No effect on
liability under State lawNothing in this section shall be
construed to modify or otherwise affect any action for damages or the liability
of any person under the law of any
State.
.
(b)Effective Date;
ApplicabilityThe amendment made by subsection (a) shall—
(1)take effect as if
included in the enactment of the Medical Device Amendments of 1976 (Public Law
94–295); and
(2)apply to any civil
action pending or filed on or after the date of enactment of this Act.
6.
(a)Not later than 1 year
after the date of the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the Secretary
), acting
through the Commissioner of Food and Drugs, shall—
(1)complete a review
of the Food and Drug Administration’s regulations and guidance pertaining to
the labeling of drugs and biological products; and
(2)revise such
regulations and guidance as appropriate to improve the clarity and readability
of such labeling.
(b)
(1)With respect to the
labeling of any drug or biological product that is approved or licensed under
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act (42 U.S.C. 262) on or after the
day that is 1 year after the date of the enactment of this Act, the revised
regulations and guidance under subsection (a)(2) shall apply as of the date of
such approval or licensure.
(2)With respect to any
drug or biological product that was so approved or licensed before such day,
the revised regulations and guidance under subsection (a)(2) shall apply as
soon as the Secretary determines practicable.
7.Disclosure of
clinical trial adverse events on FDA Web site
(a)The Secretary of
Health and Human Services, acting through the Commissioner of Food and Drugs,
shall make all clinical trial adverse events included in the registry and
results data bank of the National Institutes of Health publicly available on
the Web site of the Food and Drug Administration.
(b)In this section, the term registry
and results data bank has the meaning given to such term in section
402(j)(3)(B)(i) of the Public Health Service Act (42 U.S.C.
282(j)(3)(B)(i)).
8.Prohibition
against participation by advisory committee members with conflicts of
interestSection 712 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–1) is amended—
(1)in paragraph (2)
of subsection (b), by striking , so as to reduce
and all that
follows through the end of the paragraph and inserting a period;
(2)in subsection
(c)—
(A)by amending the
subsection heading to read as follows: Prohibition; inapplicability of
waivers
;
(B)in subparagraph
(A) of paragraph (2), by striking Except as provided under subparagraph
(B), a member
and inserting A member
;
(C)by striking
subparagraphs (B) and (C) of paragraph (2) and inserting the following:
(B)Inapplicability
of waiversA member of an
advisory committee under this Act may not, with respect to service on such
committee, be granted a written determination as referred to in section
208(b)(1) of title 18, United States Code, or a written certification as
referred to in section 208(b)(3) of title 18, United States
Code.
;
and
(D)by striking
paragraph (3);
(3)in subsection
(e)—
(A)in paragraph (1),
by inserting and
at the end;
(B)by striking
paragraphs (2) and (3); and
(C)by redesignating
paragraph (4) as paragraph (2); and
(4)by striking
subsection (f).
9.Fees relating to
advertisements for drugs and devicesPart 2 of subchapter C of chapter VII (21
U.S.C. 379g et seq.) is amended by inserting after section 736A the
following:
736A–1.Fees
relating to advertisements for drugs and devices
(a)Beginning with
respect to fiscal year 2011, each person intending to publish or disseminate an
advertisement for a drug or device during a fiscal year shall, prior to the
advertisement’s initial publication or dissemination during such fiscal year,
pay a fee to the Secretary in the amount established under subsection
(b).
(b)
(1)For each of fiscal years 2011 through 2015, the Secretary
shall establish fees under subsection (a) to generate a total revenue amount
equal to $4,000,000, except that such amount shall be adjusted for each of
fiscal years 2012 through 2015 to reflect inflation.
(2)The Secretary shall—
(A)set the amount of
fees to be assessed and collected under this section before the start of the
relevant fiscal year;
(B)make such fees
payable with respect to each distinct advertisement for a drug or device to be
published or disseminated during the fiscal year; and
(C)set the amount of
such fees without regard to the number of times on which the advertisement is
so published or disseminated.
(3)Notwithstanding
paragraph (1), the fees under this section shall be retained in each fiscal
year in an amount not to exceed the total costs for such fiscal year for the
regulation of advertisements for drugs and devices.
(c)In
this section:
(1)The term
advertisement shall be defined by the Secretary.
(2)The term
regulation of advertisements for drugs and devices—
(A)means any
regulation of advertisements for drugs and devices by the Food and Drug
Administration under this Act; and
(B)notwithstanding
subparagraph (A), excludes activities for which fees are assessed and collected
under section 736A (relating to the process for the advisory review of
prescription drug advertising).
(d)Collections and
appropriation Acts
(1)The fees authorized by this section—
(A)notwithstanding
subsection (b)(1), shall be retained in each fiscal year in an amount not to
exceed the amount specified in appropriation Acts, or otherwise made available
for obligation, for such fiscal year; and
(B)shall only be
collected and available to defray the costs for such fiscal year for the
regulation of advertisements of drugs and devices.
(2)Authorization of
appropriationsFor each of fiscal years 2011 through 2015, there
is authorized to be appropriated for the assessment, collection, and use of
fees under this section an amount equal to the total revenue amount determined
under subsection (b) for the fiscal
year.
.
10.Certain uses of
approved drugsChapter X of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by
adding at the end the following:
1011.Requirement
regarding informed consent for certain treatmentsWith respect to the prescribing of a drug
for a use not included in the approved labeling for the drug under section 505
or under section 351 of the Public Health Service Act, the Secretary shall
promulgate regulations requiring that, before prescribing the drug—
(1)the physician
inform the patient that the use for which the physician intends to prescribe
the drug has not been approved by the Food and Drug Administration; and
(2)the physician
obtain from the patient an acknowledgment of such fact and the consent of the
patient to use the drug for such use notwithstanding such
fact.
.