[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6543 Introduced in House (IH)]
111th CONGRESS
2d Session
H. R. 6543
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety
of drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 17, 2010
Mr. Dingell (for himself, Mr. Waxman, Mr. Pallone, and Mr. Stupak)
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 to improve the safety
of drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Drug Safety Enhancement Act of
2011''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--PREVENTION
Sec. 101. Registration of producers of drugs; applicable fee.
Sec. 102. Drug supply quality and safety.
Sec. 103. Inspection of producers of drugs.
Sec. 104. Prohibition against delaying, limiting, or refusing
inspection.
Sec. 105. Clarification of inspection authority related to BIMO and IRB
inspections.
Sec. 106. Notification, nondistribution, and recall of adulterated or
misbranded drug products.
Sec. 107. Notification.
TITLE II--RESPONSE
Sec. 201. Administrative detention.
Sec. 202. Destruction of adulterated, misbranded, or counterfeit drugs
offered for import.
Sec. 203. Criminal penalties.
Sec. 204. Civil penalties.
Sec. 205. Seizure.
Sec. 206. Asset forfeiture.
TITLE III--IMPORTATION AND EXPORTATION
Sec. 301. Documentation for admissibility of imports.
Sec. 302. Registration for commercial importers; fee.
Sec. 303. Registration for customs brokers.
Sec. 304. Exportation certificate program.
Sec. 305. Extraterritorial jurisdiction.
Sec. 306. Dedicated foreign inspectorate.
TITLE IV--MISCELLANEOUS
Sec. 401. Unique identification number for establishments, importers,
and customs brokers.
Sec. 402. Country of origin labeling.
Sec. 403. False or misleading reporting to FDA.
Sec. 404. Subpoena authority.
Sec. 405. Whistleblower protections.
Sec. 406. Rule of construction.
TITLE I--PREVENTION
SEC. 101. REGISTRATION OF PRODUCERS OF DRUGS; APPLICABLE FEE.
(a) Foreign Registrants.--
(1) Misbranding.--Section 502(o) of the Federal, Food,
Drug, and Cosmetic Act (21 U.S.C. 352(o)) is amended by
inserting ``if it is a drug and was manufactured, prepared,
propagated, compounded, or processed in an establishment not
duly registered under section 510(i),'' after ``not duly
registered under section 510,''.
(2) Application.--The amendment made by paragraph (1)
applies only with respect to registration (including failure to
register) under section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360) occurring on or after the date of
the enactment of this Act.
(b) Excipient Manufacturers.--
(1) In general.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall revise section 207.10 of title 21, Code of
Federal Regulations, and such other regulations as may be
necessary to require owners and operators of establishments
that engage in the manufacture, preparation, propagation,
compounding, or processing of an excipient of a drug to
register such establishments under section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360).
(2) Application.--The revisions to regulations under
paragraph (1) shall apply with respect to the manufacture,
preparation, propagation, compounding, or processing of an
excipient of a drug on or after the date that is 18 months
after the date of the enactment of this Act.
(c) Drug Listing Elements and Frequency.--
(1) In general.--Sections 510(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(j)) is amended--
(A) in paragraph (1), by amending subparagraph (C)
to read as follows:
``(C) in the case of any drug contained in an applicable
list which is described in subparagraph (A) or (B), a
qualitative and quantitative listing of each of its active and
other ingredients, and any other information that the Secretary
finds is necessary to carry out the purposes of this Act;
and''; and
(B) in paragraph (2), in the matter preceding
subparagraph (A), by inserting ``, unless otherwise
specified by the Secretary'' after ``once during the
month of December of each year''.
(2) Application.--The amendments made by paragraph (1)
apply with respect to the filing of a list under section 510(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j))
that occurs on or after the date that is 6 months after the
date of the enactment of this Act.
(d) Suspension and Cancellation of Registration.--Section 510 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by
adding at the end the following:
``(q) Suspension and Cancellation of Registration.--With respect to
any registration under this section attributable to the manufacture,
preparation, propagation, compounding, or processing of a drug:
``(1) Suspension of registration.--
``(A) In general.--Registration under this section
is subject to suspension upon a finding by the
Secretary, after notice and an opportunity for an
informal hearing, of--
``(i) a violation of this Act; or
``(ii) the knowing or repeated making of an
inaccurate or incomplete statement or
submission of information relating to the
manufacture, preparation, propagation,
compounding, processing, or importing of a
drug.
``(B) Request.--Any person or establishment whose
registration is suspended under subparagraph (A) may
request that the Secretary vacate the suspension when
such person or establishment has corrected the
violation that is the basis for such suspension.
``(C) Vacating of suspension.--If the Secretary
determines that adequate reasons do not exist to
continue the suspension of a registration under
subparagraph (A), the Secretary shall vacate such
suspension.
``(2) Cancellation of registration.--
``(A) In general.--Not earlier than 10 days after
providing the notice under subparagraph (B), the
Secretary may cancel a registration if the Secretary
determines that--
``(i) such registration was not updated in
accordance with this section or contains false,
incomplete, or inaccurate information; or
``(ii) the fee required under section 736C
for such registration has not been paid within
30 days after the date due.
``(B) Notice of cancellation.--Before cancelling
the registration of a person or establishment under
this section, the Secretary shall give notice to the
person or establishment of the Secretary's intent to
cancel the registration and the basis for such
cancellation.
``(C) Timely update or correction.--If a
registration is adequately updated or corrected no
later than 7 days after notice is provided under
subparagraph (B) with respect to the registration, the
Secretary shall not cancel such registration.''.
(e) Registration Fee.--
(1) Establishment.--Part 2 of subchapter C of chapter VII
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et
seq.) is amended by adding at the end the following:
``SEC. 736C. REGISTRATION FEE.
``(a) In General.--In the case of any registration under section
510 that is attributable to the manufacture, preparation, propagation,
compounding, processing, or importing of a drug, the Secretary shall
assess and collect an annual fee for such registration to defray the
increase in the costs of drug safety activities.
``(b) Payable Date.--A fee under this section shall be payable--
``(1) for a facility that was not registered under section
510 for the preceding fiscal year, on the date of registration;
and
``(2) for any other facility--
``(A) for fiscal year 2012, not later than the
sooner of 90 days after the date of the enactment of
this section or December 31, 2011; and
``(B) for a subsequent fiscal year, not later than
December 31 of such fiscal year.
``(c) Fee Amounts.--
``(1) Total revenue amount.--
``(A) Initial year.--For fiscal year 2012, fees
under subsection (a) shall, except as provided in
subsections (f) and (g), be established to generate a
total revenue amount that is equal to the increase in
the costs of drug safety activities (as estimated by
the Secretary) for such fiscal year.
``(B) Subsequent years.--For each of fiscal years
2013 through 2016, fees under subsection (a) shall,
except as provided in subsections (f) and (g), be the
total revenue amount for fiscal year 2012, as adjusted
under subsection (d).
``(2) Annual fee setting.--For fiscal year 2012 and each
subsequent fiscal year, the Secretary shall establish
registration fees under subsection (a)--
``(A) based on the total revenue amount applicable
under paragraph (1); and
``(B) taking into consideration the difference in
costs of inspections between foreign and domestic
establishments.
``(3) Transmission to congress.--Not later than 60 days
before the start of fiscal year 2012 and each subsequent fiscal
year, the Secretary shall transmit to the Congress--
``(A) the total revenue amount for the upcoming
fiscal year, as applicable under paragraph (1); and
``(B) the registration fees for such year, as
established under paragraph (2).
``(d) Inflation Adjustment.--For fiscal year 2013 and subsequent
fiscal years, the fee amount under subsection (c) shall be adjusted by
the Secretary by notice, published in the Federal Register, for the
respective fiscal year to reflect the greater of--
``(1) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items; United
States city average) for the 12-month period ending June 30
preceding the fiscal year for which fees are being established;
``(2) the total percentage change for the previous fiscal
year in basic pay under the General Schedule in accordance with
section 5332 of title 5, United States Code, as adjusted by any
locality-based comparability payment pursuant to section 5304
of such title for Federal employees stationed in the District
of Columbia; or
``(3) the average annual change in the cost, per full-time
equivalent position of the Food and Drug Administration, of all
personnel compensation and benefits paid with respect to such
positions for the first 5 years of the preceding 6 fiscal
years.
The adjustment made each fiscal year under this subsection will be
added on a compounded basis to the sum of all adjustments made each
fiscal year after fiscal year 2011 under this subsection.
``(e) Fee Waiver or Reduction.--The Secretary may grant to a person
a waiver from, or a reduction of, one or more fees under this section
if the Secretary finds that--
``(1) such waiver or reduction is necessary to protect the
public health; or
``(2) the assessment of the fee would impose significant
financial hardship because of limited resources available to
such person or other circumstances.
``(f) Limitations.--
``(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year 2012
unless appropriations for salaries and expenses of the Food and
Drug Administration for such fiscal year (excluding the amount
of fees appropriated for such fiscal year) are equal to or
greater than the amount of appropriations for the salaries and
expenses of the Food and Drug Administration for the fiscal
year 2012 (excluding the amount of fees appropriated for such
fiscal year) adjusted in the same manner that fee amounts are
adjusted under subsection (d).
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year
because of paragraph (1) and if at a later date in such fiscal
year the Secretary may assess such fees, the Secretary may
assess and collect such fees, without any modification in the
rate, for registration under section 510 at any time in such
fiscal year.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation.
``(2) Collections and appropriations acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an
amount not to exceed the amount specified in
appropriations Acts, or otherwise made available for
obligation, for such fiscal year; and
``(B) shall only be collected and available to
defray the costs of drug safety activities.
``(3) Authorization of appropriations.--For each of the
fiscal years 2012 through 2016, there are authorized to be
appropriated for fees under this section such sums as may be
necessary.
``(h) Collection of Unpaid Fees.--In any case in which the
Secretary does not receive payment of a fee assessed under subsection
(a) within 30 days after it is due, such fee shall be treated as a
claim of the United States Government subject to subchapter II of
chapter 37 of title 31, United States Code.
``(i) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employers, and advisory
committees not engaged in drug safety activities, be reduced to offset
the number of officers, employees, and advisory committees so engaged.
``(j) Annual Fiscal Reports.--Beginning with fiscal year 2013, not
later than 120 days after the end of each fiscal year for which fees
are collected under this section, the Secretary shall prepare and
submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the implementation of the authority
for such fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected for such fiscal year.
``(k) Relation to Other Fees.--Fees assessed and collected under
this section are in addition to other fees assessed and collected under
this Act with respect to the same person or establishment.
``(l) Definitions.--In this section:
``(1) The term `costs of drug safety activities' means the
expenses incurred in connection with drug safety activities
for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related
to such officers, employees, and committees and to
contracts with such contractors;
``(B) laboratory space;
``(C) management of information, and the
acquisition, maintenance, and repair of information
technology resources;
``(D) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(E) collecting fees under this section and
accounting for resources allocated for drug safety
activities.
``(2) The term `drug safety activities' means activities
related to compliance by persons and establishments registered
under section 510 with the requirements of this Act relating to
drugs (including research related to and the development of
standards (such as performance standards and preventive
controls), risk assessments, hazard analyses, inspection
planning and inspections, third-party inspections, compliance
review and enforcement, import review, information technology
support, test development, product sampling, risk
communication, and administrative detention).''.
(2) Transitional provisions.--
(A) First imposition of fees.--The Secretary of
Health and Human Services shall first impose the fee
established under section 736C of the Federal Food,
Drug, and Cosmetic Act, as added by paragraph (1), for
fiscal years beginning with fiscal year 2012.
(B) Sunset date.--Section 736C of the Federal Food,
Drug, and Cosmetic Act, as added by paragraph (1), does
not authorize the assessment or collection of a fee for
registration under section 510 of such Act (21 U.S.C.
360) occurring after fiscal year 2016.
(f) Modification of Registration Form.--Not later than 180 days
after the date of the enactment of this Act, the Secretary of Health
and Human Services shall modify the registration forms under section
510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to
comply with the amendments made by this section.
SEC. 102. DRUG SUPPLY QUALITY AND SAFETY.
(a) Definitions.--Section 201(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)) is amended by adding at the end the
following:
``(3) In the case of a drug, the term `component' includes--
``(A) any active ingredient or bulk drug substance;
``(B) any inactive ingredient;
``(C) any intermediate of an active ingredient, inactive
ingredient, or bulk drug substance, whether or not it appears
in the finished product and whether or not derived from any
chemical, human, animal, plant, or other material; and
``(D) any original source material for components specified
in clauses (A), (B), and (C) whether or not the original source
material--
``(i) appears in the finished product; and
``(ii) is derived from any chemical, human, animal,
plant, or other material.''.
(b) Effective Quality Systems.--
(1) Prohibited acts.--
(A) Recordkeeping.--Section 301(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is
amended--
(i) by inserting ``503C,'' after
``417(g),''; and
(ii) by inserting ``503C,'' after ``417,''.
(B) Adulteration.--Section 501 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351) is amended by
adding at the end the following:
``(j) If it is a drug that was manufactured (as defined in section
503C) by a manufacturer that is or was at the time of such manufacture
in violation of section 503C because of the failure to have in effect
or implement an effective quality system in accordance with such
section.''.
(2) System requirements.--The Federal Food, Drug, and
Cosmetic Act is amended by inserting after section 503B (21
U.S.C. 353b) the following:
``SEC. 503C. EFFECTIVE QUALITY SYSTEM FOR DRUG MANUFACTURERS.
``(a) In General.--Each manufacturer of a drug required to be
registered under section 510 shall have in effect and implement an
effective quality system.
``(b) System Requirements.--An effective quality system applicable
to a manufacturer of a drug under subsection (a) shall require each of
the following:
``(1) Management responsibility.--The manufacturer shall
ensure that--
``(A) adequate resources are provided to ensure
compliance with current good manufacturing practice;
``(B) procedures are established and maintained to
ensure timely communication of product quality issues
to appropriate levels of management, including
executive management;
``(C) periodic reviews of process performance,
product quality, and other elements of the quality
system are conducted;
``(D) the periodic reviews under subparagraph (C)
are evaluated by executive management to determine any
appropriate action; and
``(E) the integrity of data, records, and
regulatory submissions, including with respect to
accuracy, veracity, and validity, is maintained.
``(2) Quality responsibility.--
``(A) Internal, independent unit.--The manufacturer
shall establish and maintain an internal, independent
unit with the authority to ensure that all operations
related to manufacturing drugs, including those
performed by another person, are appropriately
designed, approved, conducted, monitored, and corrected
in compliance with current good manufacturing practice.
``(B) Procedures.--The manufacturer shall establish
and maintain procedures to ensure that--
``(i) any discrepancy related to
manufacturing a drug (including the
discrepancy's causes) is promptly identified,
investigated, and corrected, the recurrence of
the discrepancy is prevented, and any
corrective or preventive action is verified or
validated to ensure that such action is
effective and does not adversely affect the
drug; and
``(ii) ongoing reviews of all data related
to manufacturing a drug are conducted to
identify trends that might affect product
quality and timely actions are performed to
prevent any adverse effect on product safety,
identity, quality, strength, or purity.
``(3) Risk management.--The manufacturer shall establish
and maintain risk management procedures that ensure effective
risk assessment, control, and communication. The risk
assessment procedures shall ensure that all factors throughout
the supply chain that may reasonably be expected to indicate a
risk to the safety, identity, quality, strength, purity, or
security of any drug manufactured by that manufacturer are
identified, starting with factors relating to origin of all
components including the original source materials; information
relating to all such factors is continuously gathered,
monitored, and evaluated; and new factors are promptly
identified.
``(4) Supply chain management.--
``(A) In general.--The manufacturer shall establish
and maintain procedures that ensure the safety,
identity, quality, strength, purity, and security of
all drugs and other materials used by that
manufacturer. The supply chain procedures shall address
the entire supply chain from original source materials
used in the manufacture of the drug to the
manufacturer. The supply chain procedures shall ensure
that there is adequate followup, which shall include no
longer receiving any source materials or drugs from, or
using operations conducted by, any person who fails to
implement timely corrections for supply chain
management practices or other applicable requirements
under this Act or sections 351 or 361 of the Public
Health Service Act.
``(B) Procedures.--Supply chain management
procedures under subparagraph (A) shall include--
``(i) acceptance and rejection criteria for
each component that ensures that such component
is appropriate for its intended use and that
include, unless not feasible using current
technology, a sufficient impurity profile for
each component, including each component that
is naturally derived, except that the
requirements of this clause shall not apply to
any component of a licensed biological product
unless required under the license issued for
such product under section 351 of the Public
Health Service Act or under paragraph (5);
``(ii) onsite audits, performed by
qualified individuals, of each person that
supplies a drug or conducts operations related
to manufacturing, before such person begins
initial supply or operation and at an
appropriate frequency to assess the continued
compliance of such person with the
manufacturer's supply chain practices and with
the applicable requirements under this Act and
sections 351 and 361 of the Public Health
Service Act;
``(iii) requirements for a quality
agreement with any person who supplies a drug
or conducts operations related to manufacturing
a drug which addresses all applicable current
good manufacturing practice requirements;
``(iv) the sharing of manufacturing
information by any person who supplies a drug
or conducts operations related to
manufacturing, including timely notification
concerning any change to, discrepancy in, or
defect in, materials or operations related to
manufacturing, along with adequate information
about such change, discrepancy, or defect;
``(v) when supplying any drug to another
manufacturer, provision of a certificate of
analysis for each batch and lot that includes
complete source, manufacturing, and test
information and results; and
``(vi) methods, which shall include
acceptance and rejection criteria, adequate--
``(I) to detect, or exclude the
possibility of, the presence of any
substance that may reasonably be
expected to indicate a risk to safety,
identity, quality, strength, purity, or
security; and
``(II) to detect, or exclude the
possibility of, other risks to safety,
identity, quality, strength, purity, or
security.
``(5) Methods.--
``(A) In general.--Each manufacturer shall
establish and maintain procedures that ensure--
``(i) periodic evaluation and, where
necessary, prompt revision of methods,
including acceptance and rejection criteria, to
ensure the safety, identity, quality, strength,
purity, and security of each drug manufactured
by such manufacturer, or component used in the
manufacture of such drug;
``(ii) when any new risk is identified--
``(I) adoption of appropriate
revised or new methods; and
``(II) evaluation of every batch
and lot of drug using such revised
methods; and
``(iii) if required, an application is
submitted for timely approval by the Secretary
of the revised or new methods under section
505, 506A, 512, or 571 of this Act or section
351 of the Public Health Service Act.
``(B) Determination of risk.--Each evaluation and
revision under subparagraph (A)(i) shall be based on a
determination of risk.
``(C) Notification regarding revised method.--Each
manufacturer of a drug shall promptly notify the
Secretary and the appropriate body charged with
revision of an official compendium of any revised
method for such drug and its rationale. Such
notification shall be made in such form and manner as
the Secretary shall prescribe by regulation.
``(D) Orders regarding revised or new methods.--If
the Secretary determines that a revised or new method,
including acceptance and rejection criteria, is
appropriate for the safety, identity, quality,
strength, purity, or security of any drug, the
Secretary may by letter order any manufacturer of such
drug to promptly--
``(i) revise any method, or adopt any new
method, and any related acceptance and
rejection criteria for such drug; and
``(ii) implement such revised or new method
and any related acceptance and rejection
criteria.
``(6) Records.--
``(A) In general.--Each manufacturer shall maintain
adequate, contemporaneous records (which may be
electronic) to document conformity with requirements
under this section. Such records shall be accurate,
indelible, and legible. Each manufacturer shall
establish and maintain a procedure to ensure the
identification, storage, protection, retrieval,
retention, and disposition of such records.
``(B) Maintenance of records; inspection.--Each
manufacturer shall maintain records under subparagraph
(A) for at least 2 years from the date of the
expiration date of the drug involved and make such
records readily available for inspection by the
Secretary. Such records or copies thereof shall be
subject to photocopying or other means of reproduction
as part of such inspection. Each manufacturer shall
provide to the Secretary these records or copies
thereof in a timely manner, upon verbal or written
request by an officer or employee duly designated by
the Secretary.
``(7) Additional provisions.--If the Secretary determines
that provisions in addition to those described in paragraphs
(1) through (6) would be appropriate to provide additional
assurance of the safety, identity, quality, strength, purity,
or security of any drug, the Secretary may promulgate such
provisions by regulation.
``(c) Exemptions and Variances.--Any person subject to any
requirement prescribed pursuant to this section may petition the
Secretary for an exemption or variance from such requirement. Such a
petition shall be submitted to the Secretary in such form and manner as
the Secretary shall prescribe by regulation. If, when granting a
request for exemption or variance under this subsection, the Secretary
determines that it is appropriate to apply the exemption or variance to
more than one manufacturer, the Secretary shall publish a notice of the
exemption or variance in the Federal Register.
``(d) Definitions.--In this section:
``(1) The term `manufacturer' means any person who
manufactures a drug.
``(2) The terms `manufacture', `manufacturing', or
`manufactured' include preparation, processing, packing, or
holding.
``(3) The term `establish and maintain' means adequately--
``(A) define, document (by paper or
electronically), implement, and follow; and
``(B) review and, as needed, revise on an ongoing
basis.''.
(3) Application.--The requirements of section 503C of the
Federal Food, Drug, and Cosmetic Act, as added by paragraph
(2), apply beginning on the date that is 2 years after the date
of the enactment of this Act.
(c) Documentation of Supply Chain.--
(1) In general.--Section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j), as amended, is further amended
by adding at the end the following:
``(r) Documentation of Supply Chain.--Each establishment required
to be registered under this section for the manufacture, preparation,
propagation, compounding, or processing of a drug, shall maintain and
provide to the Secretary, upon request, adequate information, in
electronic form, establishing--
``(1) where the drug, including its raw materials, was
produced, including all preceding producers, manufacturers,
distributors, and shippers; and
``(2) that the drug, its ingredients, and its raw materials
were manufactured, prepared, propagated, compounded, processed,
distributed, shipped, warehoused, brokered, imported, and
conveyed under conditions that ensure the identity, strength,
quality, and purity of the drug.''.
(2) Application.--The amendment made by paragraph (1)
applies beginning on the date that is 2 years after the date of
the enactment of this Act.
SEC. 103. INSPECTION OF PRODUCERS OF DRUGS.
(a) Inspection.--Subsection (h) of section 510 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
(1) by striking ``(h)'' and inserting ``(h)(1)''; and
(2) by adding at the end the following:
``(2) Notwithstanding paragraph (1), every establishment engaged in
the manufacture, propagation, compounding, or processing of a drug that
is a finished dosage form or an active pharmaceutical ingredient shall
be inspected pursuant to section 704 by one or more officers or
employees duly designated by the Secretary--
``(A) at least once in the 2-year period beginning with the
date of registration of such establishment pursuant to this
section and at least once in every successive 2-year period
thereafter; or
``(B) at least once in the 4-year period beginning with the
date of registration of such establishment pursuant to this
section and at least once in every successive 4-year period
thereafter, if the Secretary determines that sufficient
information about the type of product produced in the
establishment, inspection history, compliance history, and such
additional factors as the Secretary determines by guidance,
exists to assess risk and to establish a risk-based inspection
schedule.
``(3) The Secretary shall conduct an inspection of a drug
establishment when the establishment begins to manufacture, prepare,
propagate, compound, or process a drug that is a finished dosage form
or active pharmaceutical ingredient before the drug is introduced into
interstate commerce if the active ingredient is new to the drug product
or the drug has undergone a major change requiring prior approval by
the Secretary of a supplement to an application submitted under section
505. Notwithstanding the preceding sentence, the Secretary may opt
against conducting such an inspection if the Secretary determines,
based on the inspection history of the establishment, that such an
inspection is not necessary to verify the data contained in the
application (or supplement to the application) submitted under section
505, ensure compliance with current good manufacturing practices, or
otherwise ensure the safety of the drug or ingredient.
``(4) The Secretary may inspect, pursuant to section 704, every
establishment engaged in the manufacture, propagation, compounding, or
processing of an excipient of a drug to the same extent as the
Secretary is authorized to inspect an establishment engaged in the
manufacture, propagation, compounding, or processing of any other drug.
``(5) Nothing in this subsection shall be construed as limiting the
authority of the Secretary to conduct inspections of establishments
under any other provision of the Act.
``(6) With respect to fiscal year 2012 and each subsequent fiscal
year, the Secretary shall submit an annual report to the Congress on--
``(A) funding dedicated to inspections under this
subsection of establishments engaged in the manufacture,
propagation, compounding, or processing of a drug; and
``(B) the number of such establishments for which the
frequency of such inspections has been modified pursuant to
paragraph (2).
``(7) For purposes of determining inspection frequency under
paragraph (2), the Secretary shall establish information systems
capacity sufficient to assess risk and shall develop and maintain a
risk-based system for conducting surveillance of current good
manufacturing practices by establishments engaged in the manufacture,
propagation, compounding, or processing of a drug that is a finished
dosage form or an active pharmaceutical ingredient. The Secretary shall
have such capacity in place and begin implementation of such risk-based
system not later than 3 years after the date of the enactment of the
Drug Safety Enhancement Act of 2011. Such risk-based system shall
include consideration of the class of the establishment's products and
associated risks, the date the establishment was last inspected, the
establishment's compliance and safety history, the establishment's
shipping volume and history, and such other factors as the Secretary
determines relevant to assessing the risk presented by the
establishment.''.
(b) GAO Report.--Not later than 3 years after the date of the
enactment of this Act, the Comptroller General of the United States
shall submit a report to the Congress on the risk-based process for
conducting surveillance of current good manufacturing practices
developed and implemented under section 510(h)(7) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a)(2) of this section.
(c) Application.--The amendments made by this section shall apply
to drugs introduced or delivered for introduction into interstate
commerce on or after the date of the enactment of this Act.
SEC. 104. PROHIBITION AGAINST DELAYING, LIMITING, OR REFUSING
INSPECTION.
Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351), as amended, is further amended by adding at the end the
following:
``(k) If it is a drug and it has been manufactured, processed,
packed, or held in any factory, warehouse, or establishment and the
owner, operator, or agent of such factory, warehouse, or establishment,
or any agent of a governmental authority in the foreign country within
which such factory, warehouse, or establishment is located, delays or
limits an inspection, or refuses to permit entry or inspection, under
section 510(h) or 704.''.
SEC. 105. CLARIFICATION OF INSPECTION AUTHORITY RELATED TO BIMO AND IRB
INSPECTIONS.
(a) In General.--Section 704(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(a)(1)), is amended--
(1) by inserting after the second sentence the following:
``For purposes of enforcement of this Act, officers or
employees duly designated by the Secretary, upon presenting
appropriate credentials and a written notice to the owner,
operator, or agent in charge, are also authorized to enter, at
reasonable times, any premises of a clinical investigator,
sponsor, monitor, contract research organization, site
management organization, institutional review board, or other
person that oversees, initiates, or conducts a clinical
investigation subject to section 505(i), or a postmarket study
or clinical trial subject to section 505(k) or 505(o).''; and
(2) by inserting ``or any establishment associated with a
clinical investigation subject to section 505(i), or a
postmarket study or clinical trial subject to section 505(k) or
505(o) (including the premises of any clinical investigator,
sponsor, monitor, contract research organization, site
management organization, person that oversees or participates
in data acquisition, data generation, data archiving, or data
analysis, institutional review board, or any other person,
other than a subject, that participates in the conduct of a
clinical investigation of a drug),'' before ``inspection shall
extend to all things therein''.
(b) Conforming Amendment.--Section 704(a)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(a)(2)) is amended by striking
``third sentence'' and inserting ``fourth sentence''.
SEC. 106. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR
MISBRANDED DRUG PRODUCTS.
(a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(uu)(1) The failure to notify the Secretary in violation of
section 568(a).
``(2) The failure to comply with any order issued under section
568.''.
(b) Notification, Nondistribution, and Recall of Adulterated or
Misbranded Drugs.--Subchapter E of chapter V of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the
end the following:
``SEC. 568. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR
MISBRANDED DRUGS.
``(a) Notification, Nondistribution, and Recall of Adulterated or
Misbranded Drugs.--
``(1) In general.--A person required, with respect to
drugs, to register under section 510, 801(r), or 801(s) that
has reason to believe that--
``(A) a drug when introduced into or while in
interstate commerce, or while held for sale (regardless
of whether the first sale) after shipment in interstate
commerce, is adulterated or misbranded, and
``(B) as a result, the use or consumption of, or
exposure to, the drug (or an ingredient or component
used in any such drug) may result in illness or injury
to humans or animals,
shall, as soon as practicable, notify the Secretary of the
identity and location of the drug.
``(2) Manner of notification.--Notification under paragraph
(1) shall be made in such manner and by such means as the
Secretary may require by regulation.
``(b) Voluntary Recall.--The Secretary may request that any person
who distributes a drug that the Secretary has reason to believe is
adulterated, misbranded, or otherwise in violation of this Act
voluntarily--
``(1) recall such drug; and
``(2) provide for notice, including to individuals as
appropriate, to persons who may be affected by the recall.
``(c) Order To Cease Distribution.--If the Secretary has reason to
believe that the use or consumption of, or exposure to, a drug may
result in illness or injury to humans or animals, the Secretary shall
have the authority to issue an order requiring any person who
distributes such drug to immediately cease distribution of such drug.
``(d) Action Following Order.--Any person who is subject to an
order under subsection (c) shall immediately cease distribution of such
drug and provide notification as required by such order, and may appeal
within 24 hours of issuance of such order to the Secretary. Such appeal
may include a request for an informal hearing and a description of any
efforts to recall such drug undertaken voluntarily by the person,
including after a request under subsection (b). Except as provided in
subsection (f), an informal hearing shall be held as soon as
practicable, but not later than 5 calendar days, or less as determined
by the Secretary, after such an appeal is filed, unless the parties
jointly agree to an extension. After affording an opportunity for an
informal hearing, the Secretary shall determine whether the order
should be amended to require a recall of such drug. If, after providing
an opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by the order,
the Secretary shall vacate the order.
``(e) Order To Recall.--
``(1) Amendment.--Except as provided under subsection (f),
if after providing an opportunity for an informal hearing under
subsection (d), the Secretary determines that the order should
be amended to include a recall of the drug with respect to
which the order was issued, the Secretary shall amend the order
to require a recall.
``(2) Contents.--An amended order under paragraph (1)
shall--
``(A) specify a timetable in which the recall will
occur;
``(B) require periodic reports to the Secretary
describing the progress of the recall; and
``(C) provide for notice, including to individuals
as appropriate, to persons who may be affected by the
recall. In providing for such notice, the Secretary may
allow for the assistance of health professionals, State
or local officials, or other individuals designated by
the Secretary.
``(f) Emergency Recall Order.--
``(1) In general.--If the Secretary has credible evidence
or information that a drug subject to an order under subsection
(c) presents an imminent threat of serious adverse health
consequences or death to humans or animals, the Secretary may
issue an order requiring any person who distributes such drug--
``(A) to immediately recall such drug; and
``(B) to provide for notice, including to
individuals as appropriate, to persons who may be
affected by the recall.
``(2) Action following order.--Any person who is subject to
an emergency recall order under this subsection shall
immediately recall such drug and provide notification as
required by such order, and may appeal within 24 hours after
issuance such order to the Secretary. The person subject to an
emergency recall order shall conduct the recall notwithstanding
the pendency of any such appeal. An informal hearing shall be
held as soon as practicable but not later than 5 calendar days,
or less as determined by the Secretary, after such an appeal is
filed, unless the parties jointly agree to an extension. After
affording an opportunity for an informal hearing, the Secretary
shall determine whether the order should be amended pursuant to
subsection (e)(1). If, after providing an opportunity for such
a hearing, the Secretary determines that inadequate grounds
exist to support the actions required by the order, the
Secretary shall vacate the order.
``(g) Notice to Consumers and Health Officials.--The Secretary
shall, as the Secretary determines to be necessary, provide notice of a
recall order under this section to consumers to whom the drug was, or
may have been, distributed and to appropriate State and local health
officials.
``(h) Savings Clause.--Nothing contained in this section shall be
construed as limiting--
``(1) the authority of the Secretary to issue an order to
cease distribution of, or to recall, a drug under any other
provision of this Act or the Public Health Service Act; or
``(2) the ability of the Secretary to request any person to
perform a voluntary activity related to any drug subject to
this Act or the Public Health Service Act.''.
(c) Articles Subject to Refusal.--The third sentence of subsection
(a) of section 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381) is amended by inserting ``or (4) in the case of a drug,
such article is subject to an order under section 568 to cease
distribution of or recall the article,'' before ``then such article
shall be refused admission''.
(d) Application.--Sections 301(uu) and 568 of the Federal Food,
Drug, and Cosmetic Act, as added by subsections (a) and (b), shall
apply with respect to a drug as of such date, not later than 1 year
after the date of the enactment of this Act, as the Secretary of Health
and Human Services shall specify.
SEC. 107. NOTIFICATION.
(a) In General.--
(1) Prohibited acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331), as amended, is further
amended by adding at the end the following:
``(vv) The failure to notify the Secretary in violation of section
569.''.
(2) Notification.--Subchapter E of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as
amended, is further amended by adding at the end the following:
``SEC. 569. NOTIFICATION.
``(a) Notification to Secretary.--With respect to a drug, the
Secretary may require notification to the Secretary by a regulated
person of--
``(1) the use of, or exposure to, such drug which may
result in illness or injury to humans or animals;
``(2) a significant loss or known theft of such drug;
``(3) a reasonable probability that such drug has been or
is being counterfeited;
``(4) repeated failures by a manufacturer of a component or
other material used in the manufacture of such drug to ensure
compliance with applicable quality systems requirements under
section 501(a)(2)(B) or 503C of this Act or section 351 or 361
of the Public Health Service Act;
``(5) any incident causing such drug to be mistaken for, or
its labeling applied to, another drug;
``(6) any contamination or any significant chemical,
physical, or other change or deterioration in such drug after
distribution, or any failure of a distributed lot or batch of
such drug to meet an established specification; and
``(7) any other type of information regarding such drug
that the Secretary deems necessary for protection of the public
health.
``(b) Manner of Notification.--Notification under this section
shall be made in such manner and by such means as the Secretary may
require by regulation or guidance.
``(c) Definition.--In this section, the term `regulated person'
means a person who is required to register under section 510, 801(r),
or 801(s); a wholesale distributor of a drug product; and any other
person that distributes drugs except exclusively for retail sale.''.
(b) Exchange of Information.--
(1) Prohibited acts.--
(A) In general.--The first sentence of section
301(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(j)) is amended--
(i) by striking ``or'' before ``to the
courts when relevant''; and
(ii) by inserting ``, or as specified in
section 708,'' before ``any information
acquired''.
(B) Technical corrections.--The first sentence of
such section 301(j) is further amended--
(i) by striking ``573.'' and inserting
``573''; and
(ii) by striking the second of the two
consecutive periods at the end.
(2) Amendment.--Section 708 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379) is amended--
(A) by striking ``The Secretary'' and inserting
``(a) The Secretary''; and
(B) by adding at the end the following:
``(b)(1)(A) The Secretary may provide to any Federal agency acting
within the scope of its jurisdiction any information respecting a drug
that is exempt from disclosure pursuant to subsection (a) of section
552 of title 5, United States Code, by reason of subsection (b)(4) of
such section.
``(B) Any such information provided to another Federal agency shall
not be disclosed by such agency except in any investigation within the
receiving agency's jurisdiction or in an action or proceeding under the
laws of the United States in which the receiving agency or the United
States is a party.
``(2)(A) In carrying out this Act, the Secretary may provide to a
State or local government agency any information respecting a drug that
is exempt from disclosure pursuant to section 552(a) of title 5, United
States Code, by reason of subsection (b)(4) of such section.
``(B) Any such information provided to a State or local government
agency shall not be disclosed by such agency.
``(3) Except as provided by section 301(j), in carrying out this
Act, the Secretary may provide to any person any information respecting
a drug that is exempt from disclosure pursuant to section 552(a) of
title 5, United States Code, by reason of subsection (b)(4) of such
section, if the Secretary determines that providing the information to
the person is appropriate under the circumstances and the recipient
provides adequate assurances to the Secretary that the recipient will
preserve the confidentiality of the information.
``(4) In carrying out this Act, the Secretary may provide any
information respecting a drug that is exempt from disclosure pursuant
to section 552(a) of title 5, United States Code, by reason of
subsection (b)(4) of such section--
``(A) to any foreign government agency; or
``(B) any international organization established by law,
treaty, or other governmental action and having
responsibility--
``(i) to facilitate global or regional
harmonization of standards and requirements in an area
of responsibility of the Food and Drug Administration;
or
``(ii) to promote and coordinate public health
efforts, if the agency or organization provides
adequate assurances to the Secretary that the agency or
organization will preserve the confidentiality of the
information.
``(c) Except as provided by section 301(j), the Secretary may
disclose to the public any information respecting a drug that is exempt
from disclosure pursuant to section 552(a) of title 5, United States
Code, by reason of subsection (b)(4) of such section, if the Secretary
determines that such disclosure is necessary to protect the public
health.
``(d) Except as provided in subsection (e), the Secretary shall not
be required to disclose under section 552 of title 5, United States
Code, or any other provision of law any information respecting a drug
obtained from a Federal, State, or local government agency, or from a
foreign government agency, or from an international organization
described in subsection (b)(4), if the agency or organization has
requested that the information be kept confidential, or has precluded
such disclosure under other use limitations, as a condition of
providing the information.
``(e) Nothing in subsection (d) authorizes the Secretary to
withhold information from the Congress or prevents the Secretary from
complying with an order of a court of the United States.
``(f) This section shall not affect the authority of the Secretary
to provide or disclose information under any other provision of law.''.
TITLE II--RESPONSE
SEC. 201. ADMINISTRATIVE DETENTION.
(a) Administrative Detention of Drugs.--Section 304 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding at
the end the following:
``(i) Administrative Detention of Drugs.--
``(1) Detention authority.--
``(A) In general.--If during any lawful activity
conducted by an officer or employee, a drug which such
officer or employee has reason to believe is in
violation of any provision of this Act is found, such
officer or employee may order the drug detained (in
accordance with regulations prescribed by the
Secretary) for a reasonable period which may not exceed
20 days unless the Secretary determines that a period
of detention greater than 20 days is required to
institute an action under subsection (a) or section
302, in which case the Secretary may authorize a
detention period of not to exceed 60 days.
``(B) Secretary's approval.--Regulations of the
Secretary prescribed under this paragraph shall require
that, before a drug may be ordered detained under this
paragraph, the Secretary or an officer or employee
designated by the Secretary approve such order.
``(C) Security of detained drug.--A detention order
under this paragraph may require--
``(i) the labeling or marking of a drug
during the period of its detention for the
purpose of identifying the drug as detained;
and
``(ii) that the drug be removed to a secure
facility, as appropriate.
``(D) Appeal of detention order.--
``(i) Right to appeal.--Any person who
would be entitled to claim a drug if it were
seized under subsection (a) may appeal to the
Secretary a detention of such drug under this
paragraph.
``(ii) Hearing and response.--Within 15
days of the date an appeal of a detention is
filed with the Secretary, the Secretary shall
after affording opportunity for an informal
hearing by order confirm the detention or
revoke it.
``(2) Limitation on movement of detained drugs.--
``(A) In general.--Except as authorized by
subparagraph (B), a drug subject to a detention order
issued under paragraph (1) shall not be moved by any
person from the place at which it is ordered detained
until--
``(i) released by the Secretary; or
``(ii) the expiration of the detention
period applicable to such order,
whichever occurs first.
``(B) Exception.--A drug subject to a detention
order under paragraph (1) may be moved--
``(i) in accordance with regulations
prescribed by the Secretary; and
``(ii) if not in final form for shipment,
at the discretion of the manufacturer of the
device for the purpose of completing the work
required to put it in such form.''.
(b) Regulations.--The Secretary shall issue regulations or guidance
to implement the amendments made by this section.
(c) Prohibited Acts.--Section 301(r) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), is amended--
(1) by inserting ``, drug,'' after ``device'', each place
it appears; and
(2) by inserting ``or section 304(i)'' after ``section
304(g)''.
(d) Effective Date.--The amendments made by this section shall
apply beginning on the day that is 180 days after the date of enactment
of this Act.
SEC. 202. DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS
OFFERED FOR IMPORT.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the
following:
``(q)(1) Subject to paragraph (2), the Secretary of the Treasury
shall cause the destruction, upon referral from the Secretary of Health
and Human Services, of any drug that--
``(A) poses a reasonable probability of causing a
significant adverse health effect, as determined by the
Secretary of Health and Human Services; or
``(B) is valued at an amount that is $2,000 or less (or
such higher amount as the Secretary of the Treasury may set by
regulation pursuant to section 498 of the Tariff Act of 1930).
``(2) The Secretary of Health and Human Services shall issue
regulations providing for notice and an opportunity for an informal
hearing for destruction of drugs under paragraph (1). The regulations
under this paragraph shall allow the Secretary of Health and Human
Services to provide the notice and opportunity for an informal hearing
to the owner or consignee after the destruction has occurred.
``(3) For a drug not described in paragraph (1), the Secretary of
Health and Human Services shall provide for notice and an opportunity
for an informal hearing to the owner or consignee before the
destruction of the drug under the fifth sentence of subsection (a).''.
(b) Conforming Amendment.--The fifth sentence of subsection (a) of
section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381)
is amended by striking ``The Secretary of the Treasury shall'' and
inserting ``Except as provided in subsection (q), the Secretary of the
Treasury shall''.
(c) Application.--The amendments made by subsections (a) and (b)
shall apply beginning on the day that is 90 days after the date of the
enactment of this Act.
SEC. 203. CRIMINAL PENALTIES.
Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by striking ``Any'' and
inserting ``Except as provided in paragraph (2) or (3),
any''; and
(B) by adding at the end the following:
``(3) Notwithstanding paragraph (1), any person who, with respect
to a drug, knowingly violates paragraph (a), (b), (c), (d), (f), (g),
(i), (k), or (jj)(3) of section 301 shall be imprisoned for not more
than 10 years or fined in accordance with title 18, United States Code,
or both.''; and
(2) in subsection (b)(1), by striking ``fined not more than
$250,000'' and inserting ``fined in accordance with title 18,
United States Code''.
SEC. 204. CIVIL PENALTIES.
(a) In General.--Section 303(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(f)) is amended by striking paragraph (4)
and inserting the following:
``(4)(A) Except as provided in paragraph (3) and subsection
(g), any person who violates a requirement of this Act that
relates to drugs shall be subject to a civil penalty in an
amount not to exceed--
``(i) $500,000 for each such violation; and
``(ii) for all such violations adjudicated in a
single proceeding, $10,000,000.
``(B) Each violation described in subparagraph (A) and each
day during which the violation continues shall be considered to
be a separate offense.''.
(b) Conforming Amendments.--
(1) Section 303(f)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(f)(3)) is amended--
(A) in subparagraph (A), by striking ``Any person
who'' and inserting ``Notwithstanding paragraph (4),
any person who''; and
(B) in subparagraph (B), by striking ``If a
violation of'' and inserting ``Notwithstanding
paragraph (4), if a violation of''.
(2) Section 303(g)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(g)(1)) is amended by striking
``With respect to a person who'' and inserting
``Notwithstanding subsection (f)(4), with respect to a person
who''.
SEC. 205. SEIZURE.
Section 304(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 334(b)) is amended--
(1) by striking ``(b)'' and inserting ``(b)(1)''; and
(2) by adding at the end the following:
``(2) Procedure With Respect to Drugs; Multiplicity of Pending
Proceedings.--In the case of a violation relating to a drug, the
article, equipment, or other thing proceeded against shall be liable to
seizure by process pursuant to the libel, and the procedure in cases
under this section shall conform, as nearly as may be, to the procedure
in admiralty rather than the procedure used for civil asset forfeiture
proceedings set forth in section 983 of title 18, United States Code.
On demand of either party, any issue of fact joined in any such case
brought under this section shall be tried by jury. Any such seizure
brought under this section is not governed by Rule G of the
Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture
Actions. In addition, exigent circumstances shall be deemed to exist
for all such seizures brought under this section, and in such cases,
the summons and arrest warrant shall be issued by the clerk of the
court without court review. When libel for condemnation proceedings
relating to a drug under this section, involving the same claimant and
the same issues of adulteration or misbranding, are pending in two or
more jurisdictions, such pending proceedings, upon application of the
claimant reasonably made to the court of one such jurisdiction, shall
be consolidated for trial by order of such court, and tried in (1) any
district selected by the claimant where one of such proceedings is
pending; or (2) a district agreed upon by stipulation between the
parties. If no order for consolidation is so made within a reasonable
time, the claimant may apply to the court of one such jurisdiction, and
such court (after giving the United States attorney for such district
reasonable notice and opportunity to be heard) shall by order, unless
good cause to the contrary is shown, specify a district of reasonable
proximity to the claimant's principal place of business, in which all
such pending proceedings shall be consolidated for trial and tried.
Such order of consolidation shall not apply so as to require the
removal of any case the date for trial of which has been fixed. The
court granting such order shall give prompt notification thereof to the
other courts having jurisdiction of the cases covered thereby.''.
SEC. 206. ASSET FORFEITURE.
(a) In General.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the
following:
``(h) Forfeiture Related to Violations With Respect to Drugs.--
``(1) Criminal forfeiture.--Any person convicted of a
violation of section 301 with respect to drugs, or a conspiracy
to commit such violation, shall forfeit to the United States
any property, real or personal, constituting or traceable to
the gross proceeds obtained, directly or indirectly, as a
result of such violation. Pursuant to section 2461(c) of title
28, United States Code, the provisions of section 413 of the
Controlled Substances Act, except subsections (a), (d), and (q)
of such section 413, shall apply to criminal forfeitures under
this paragraph.
``(2) Civil forfeiture.--Any property, real or personal,
constituting or traceable to the gross proceeds obtained,
directly or indirectly, as a result of a violation of section
301 with respect to drugs, or a conspiracy to commit such
violation, is subject to forfeiture to the United States in
accordance with the provisions of chapter 46 of title 18,
United States Code, except that such duties as are imposed upon
the customs officer or any other person with respect to the
seizure and forfeiture of property under the customs laws as
described in section 981(d) of title 18, United States Code,
shall be performed with respect to seizures and forfeitures of
property under this section by such officers, agents, or other
persons as may be authorized or designated for that purpose by
the Secretary.''.
(b) Civil Forfeiture Statute Definition.--Subparagraph (C) of
section 983(i)(2) of title 18, United States Code, is amended to read
as follows:
``(C) section 304 of the Federal Food, Drug, and
Cosmetic Act;''.
TITLE III--IMPORTATION AND EXPORTATION
SEC. 301. DOCUMENTATION FOR ADMISSIBILITY OF IMPORTS.
(a) Prohibition.--Section 301 of the Federal, Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended, is further amended by adding
at the end the following:
``(ww) The submission (with respect to drugs) of information that
is required pursuant to section 801 that is inaccurate or incomplete.
``(xx) The failure (with respect to drugs) to submit information
that is required pursuant to section 801.''.
(b) Documentation for Imports.--Section 801 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is further amended
by adding at the end the following:
``(r) Documentation.--
``(1) Submission.--The Secretary may require by regulation
the submission of documentation or other information for a drug
that is imported or offered for import into the United States.
When developing any regulation in accordance with this
paragraph, to the extent that the collection of documentation
or other information involves Customs and Border Protection
efforts or resources, the Secretary shall consult with Customs
and Border Protection.
``(2) Format.--A regulation under paragraph (1) may specify
the format for submission of the documentation or other
information.
``(3) Refusal of admission.--A drug imported or offered for
import into the United States shall be refused admission unless
all documentation and information the Secretary requires under
this Act or the Public Health Service Act for such article is
submitted.''.
SEC. 302. REGISTRATION FOR COMMERCIAL IMPORTERS; FEE.
(a) Registration.--
(1) Prohibitions.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331), as amended, is further
amended by adding at the end the following:
``(yy) The failure to register in accordance with section
801(s).''.
(2) Misbranding.--Section 502(o) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(o)), as amended, is further
amended by inserting ``if it is imported or offered for import
by an importer not duly registered under section 801(s),''
before ``or if it does not bear''.
(3) Registration.--Section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381) is amended by adding at the
end the following:
``(s) Registration of Importers.--
``(1) Registration.--The Secretary shall require an
importer of drugs--
``(A) to be registered with the Secretary in a form
and manner specified by the Secretary; and
``(B) consistent with section 1012, to submit
appropriate unique identifiers as a condition of
registration.
``(2) Good importer practices.--The maintenance of
registration under this subsection is conditioned on compliance
with good importer practices in accordance with the following:
``(A) The Secretary, in consultation with Customs
and Border Protection, shall promulgate regulations to
establish good importer practices that specify the
measures an importer shall take to ensure imported
drugs are in compliance with the requirements of this
Act and the Public Health Service Act.
``(B) The measures under subparagraph (A) shall
ensure that the importer--
``(i) has adequate information about the
article, its hazards, and the requirements of
this Act and the Public Health Service Act
applicable to such article;
``(ii) has adequate information or
procedures in place to verify that both the
article and each person that produced,
manufactured, processed, packed, transported,
or held the article, including components of
the article, are in compliance with the
requirements of this Act and the Public Health
Service Act; and
``(iii) has adequate procedures in place to
take corrective action, such as the ability to
appropriately trace, withhold, and recall
articles, if an article imported by the
importer is not in compliance with the
requirements of this Act or the Public Health
Service Act.
``(C) In promulgating good importer practice
regulations under this subsection, the Secretary may,
as appropriate, take into account differences among
importers and the types of imports, including based on
the level of risk posed by the imported drug.
``(3) Suspension of registration.--
``(A) In general.--Registration under this
subsection is subject to suspension upon a finding by
the Secretary, after notice and an opportunity for an
informal hearing, of--
``(i) a violation of this Act; or
``(ii) the knowing or repeated making of an
inaccurate or incomplete statement or
submission of information relating to the
importation of a drug.
``(B) Request.--The importer whose registration is
suspended may request that the Secretary vacate the
suspension of registration when such importer has
corrected the violation that is the basis for such
suspension.
``(C) Vacating of suspension.--If the Secretary
determines that adequate reasons do not exist to
continue the suspension of a registration, the
Secretary shall vacate such suspension.
``(4) Cancellation of registration.--
``(A) In general.--Not earlier than 10 days after
providing the notice under subparagraph (B), the
Secretary may cancel a registration if the Secretary
determines that--
``(i) such registration was not updated in
accordance with this section or otherwise
contains false, incomplete, or inaccurate
information; or
``(ii) the registration fee required under
section 743 for such registration has not been
paid within 30 days after the date due.
``(B) Notice of cancellation.--Cancellation shall
be preceded by notice to the importer of the intent to
cancel the registration and the basis for such
cancellation.
``(C) Timely update or correction.--If the
registration for the importer is updated or corrected
no later than 7 days after notice is provided under
subparagraph (B), the Secretary shall not cancel such
registration.
``(5) Exemptions.--The Secretary, by notice in the Federal
Register--
``(A) shall establish an exemption from the
requirements of this subsection for importations for
personal use; and
``(B) may establish other exemptions from the
requirements of this subsection.''.
(4) Regulations.--Not later than 36 months after the date
of the enactment of this Act, the Secretary of Health and Human
Services in consultation with the Commissioner responsible for
Customs and Border Protection shall promulgate the regulations
required to carry out section 801(s) of the Federal Food, Drug,
and Cosmetic Act, as added by paragraph (3). In establishing
the effective date of a regulation promulgated under section
801(s), the Secretary shall, in consultation with the
Commissioner responsible for Customs and Border Protection, as
appropriate, provide a reasonable period of time for an
importer of a drug to comply with good importer practices,
taking into account differences among importers and the types
of imports, including based on the level of risk posed by the
imported product.
(5) Effective date.--The amendments made by this subsection
shall take effect on the date that is 24 months after the date
of enactment of this Act.
(b) Fee.--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 6--IMPORTERS OF DRUGS
``SEC. 743. IMPORTERS OF DRUGS.
``(a) Importers.--The Secretary shall assess and collect an annual
fee for the registration of an importer under section 801(s).
``(b) Amount of Fee.--
``(1) Base amounts.--The registration fee under subsection
(a) shall be--
``(A) for fiscal year 2012, $500; and
``(B) for fiscal year 2013 and each subsequent
fiscal year, the fee for fiscal year 2012 as adjusted
under paragraph (2).
``(2) Adjustment.--For fiscal year 2013 and subsequent
fiscal years, the fees established pursuant to paragraph (1)
shall be adjusted by the Secretary by notice, published in the
Federal Register, for a fiscal year to reflect the greater of--
``(A) the total percentage change that occurred in
the Consumer Price Index for all urban consumers (all
items; United States city average) for the 12-month
period ending June 30 preceding the fiscal year for
which fees are being established;
``(B) the total percentage change for the previous
fiscal year in basic pay under the General Schedule in
accordance with section 5332 of title 5, United States
Code, as adjusted by any locality-based comparability
payment pursuant to section 5304 of such title for
Federal employees stationed in the District of
Columbia; or
``(C) the average annual change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 5 years of the preceding 6 fiscal years.
``(3) Compounded basis.--The adjustment made each fiscal
year pursuant to this subsection shall be added on a compounded
basis to the sum of all adjustments made each fiscal year after
fiscal year 2012 under this subsection.
``(4) Waiver for importers required to pay registration
fee.--The Secretary shall waive the fee applicable to a person
under this section if such person is required to pay both--
``(A) a fee under section 736C for registration of
one or more establishments under section 510, for
drugs; and
``(B) a fee under this section for registration as
an importer under section 801(s).
``(c) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation.
``(2) Collections and appropriations acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an
amount not to exceed the amount specified in
appropriations Acts, or otherwise made available for
obligation, for such fiscal year; and
``(B) shall only be collected and available to
cover the costs associated with registering importers
under sections 801(s) and with ensuring compliance with
good importer practices.
``(3) Authorization of appropriations.--For each of fiscal
years 2012 through 2016, there are authorized to be
appropriated for fees under this section such sums as may be
necessary.''.
(c) Inspection.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the
following:
``(h) Importers.--Every person engaged in the importing of any drug
shall, upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable times to
inspect the facilities of such person and have access to, and to copy
and verify, any related records.''.
SEC. 303. REGISTRATION FOR CUSTOMS BROKERS.
(a) Registration.--
(1) Prohibitions.--Section 301(yy) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331), as added by section
302(a)(1), is amended by inserting ``or 801(t)'' after
``801(s)''.
(2) Misbranding.--Section 502(o) (21 U.S.C. 352(o)), as
amended by section 302(a)(2), is amended--
(A) by inserting ``or a customs broker'' after ``by
an importer''; and
(B) by inserting ``or 801(t)'' after ``801(s)''.
(3) Registration.--Section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381), as amended, is further
amended by adding at the end the following:
``(t) Registration of Customs Broker.--
``(1) Registration.--The Secretary shall require a customs
broker, with respect to the importation of drugs--
``(A) to be registered with the Secretary in a form
and manner specified by the Secretary; and
``(B) consistent with section 1012, to submit
appropriate unique identifiers as a condition of
registration.
``(2) Cancellation of registration.--
``(A) In general.--Not earlier than 10 days after
providing the notice under subparagraph (B), the
Secretary may cancel a registration that the Secretary
determines was not updated in accordance with this
section or other wise contains false, incomplete, or
inaccurate information.
``(B) Notice of cancellation.--Cancellation shall
be preceded by notice to the customs broker of the
intent to cancel the registration and the basis for
such cancellation.
``(C) Timely update or correction.--If the
registration for the customs broker is updated or
corrected no later than 7 days after notice is provided
under subparagraph (B), the Secretary shall not cancel
such registration.
``(3) Notification.--The Secretary shall notify the
Commissioner responsible for Customs and Border Protection
whenever the Secretary cancels a registration under this
subsection.
``(4) Exemptions.--In consultation with the Commissioner
responsible for Customs and Border Protection, the Secretary,
by notice published in the Federal Register--
``(A) shall establish an exemption from the
requirements of this subsection for importations for
personal use; and
``(B) may establish other exemptions from the
requirements of this subsection.
``(5) Civil penalties.--Notwithstanding any other provision
in this Act, a customs broker who violates section 301 because
of a violation of subsection (ww), (xx), or (yy) of such
section shall not be subject to a civil penalty under section
303(f)(1)(C) of this Act.''.
(4) Regulations.--Not later than 24 months after the date
of the enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Commissioner responsible for
Customs and Border Protection, shall promulgate the regulations
required to carry out section 801(t) of the Federal Food, Drug,
and Cosmetic Act, as added by paragraph (3).
(5) Effective date.--The amendments made by this subsection
shall take effect on the date that is 24 months after the date
of enactment of this Act.
(b) Inspection.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374), as amended, is further amended by adding
at the end the following:
``(i) Brokers.--Every customs broker required to be registered with
the Secretary shall, upon request of an officer or employee designated
by the Secretary, permit such officer or employee at all reasonable
times to inspect the facilities of such person and have access to, and
to copy and verify, any related records.''.
SEC. 304. EXPORTATION CERTIFICATE PROGRAM.
Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381(e)(4)) is amended--
(1) in subparagraph (B), by striking ``If the Secretary''
and inserting ``With respect to a device, if the Secretary'';
and
(2) by adding at the end the following:
``(C) With respect to a drug:
``(i) A certification by the Secretary under
subparagraph (A) need not be in writing.
``(ii) Subparagraph (A) applies only with respect
to exportation from the United States.
``(iii) Any person who exports from a country other
than the United States a drug approved in the United
States may request that the Secretary certify that the
exported drug meets the applicable requirements of this
Act. The Secretary shall issue such a certification
within 20 days of the receipt of a request for such
certification if the request demonstrates that the drug
meets the applicable requirements of this Act.
``(iv) For purposes of this subparagraph, a
certification by the Secretary shall be made on such
basis and in such form (such as a publicly available
listing) as the Secretary determines appropriate.
``(v) If the Secretary, with respect to a drug,
issues an export certification within the 20 days
prescribed by subparagraph (A) or clause (iii) of this
subparagraph, a fee for such certification may be
charged but such fee shall not exceed such amount as
the Secretary determines is reasonably related to the
cost of issuing such certificates. The Secretary may
adjust this fee annually to account for inflation and
other cost adjustments. Fees collected for a fiscal
year pursuant to this subparagraph shall be credited to
the appropriation account for salaries and expenses of
the Food and Drug Administration and shall be available
in accordance with appropriations Acts until expended,
without fiscal year limitation. Such fees shall be
collected in each fiscal year in an amount equal to the
amount specified in appropriations Acts for such fiscal
year and shall only be collected and available for the
costs of the Food and Drug Administration to cover the
cost of issuing such certifications. Such sums as
necessary may be transferred from such appropriation
account for salaries and expenses of the Food and Drug
Administration without fiscal year limitation to such
appropriation account for salaries and expenses with
fiscal year limitation.''.
SEC. 305. EXTRATERRITORIAL JURISDICTION.
(a) In General.--Chapter III of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end
the following:
``SEC. 311. EXTRATERRITORIAL JURISDICTION.
``There is extraterritorial jurisdiction over any violation of this
Act relating to any drug if such drug was intended for import into the
United States or if any act in furtherance of the violation was
committed in the United States.''.
(b) Prohibition.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended, is further amended by adding
at the end the following:
``(zz) The production, manufacture, processing, preparation,
packing, holding, or distribution of an adulterated or misbranded drug
with the knowledge or intent that such drug will be imported into the
United States, or the production, manufacture, processing, preparation,
packing, holding, or distribution of a drug with the knowledge or
intent that the drug will be imported into the United States in
violation of section 505.''.
SEC. 306. DEDICATED FOREIGN INSPECTORATE.
Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
374), as amended, is further amended by adding at the end the
following:
``(j) The Secretary shall establish and maintain a corps of
inspectors dedicated to inspections of foreign drug facilities and
establishments. This corps shall be staffed and funded by the Secretary
at a level sufficient to allow it to conduct inspections of foreign
drug facilities and establishments at a frequency at least equivalent
to the inspection rate of domestic drug facilities and
establishments.''.
TITLE IV--MISCELLANEOUS
SEC. 401. UNIQUE IDENTIFICATION NUMBER FOR ESTABLISHMENTS, IMPORTERS,
AND CUSTOMS BROKERS.
Chapter 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:
``SEC. 1012. UNIQUE IDENTIFIER.
``(a) Registration of Establishments.--A person required to
register a drug establishment pursuant to section 510 shall submit, at
the time of registration, a unique identifier for the establishment.
``(b) Registration of Importers and Customs Brokers.--A person
required to register pursuant to section 801(s) or 801(t) shall submit,
at the time of registration, a unique identifier for the principal
place of business for which such person is required to register under
section 801(s) or 801(t).
``(c) Guidance.--The Secretary may, by guidance, and, with respect
to importers and customs brokers, in consultation with the Commissioner
responsible for Customs and Border Protection, specify the unique
numerical identifier system to be used to meet the requirements of
subsections (a) and (b) and the form, manner, and timing of a
submission under such subsections. Development of such guidance shall
take into account the utilization of existing unique identification
schemes and compatibility with customs automated systems.
``(d) Importation.--A drug imported or offered for import shall be
refused admission unless the appropriate unique identifiers, as
specified by the Secretary, are provided for such article.''.
SEC. 402. COUNTRY OF ORIGIN LABELING.
(a) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(aa) If it is a finished dosage form drug and the Web site of the
manufacturer of such drug does not list--
``(1) the country of origin for each active pharmaceutical
ingredient; and
``(2) the place of manufacture of the finished dosage form
of such drug.''.
(b) Regulations.--Not later than 3 years after the date of the
enactment of this Act, the Secretary shall promulgate final regulations
to carry out section 502(aa) of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a).
(c) Effective Date.--The requirement of section 502(aa) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), takes
effect 4 years after the date of the enactment of this Act.
SEC. 403. FALSE OR MISLEADING REPORTING TO FDA.
(a) In General.--Section 301(q)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(q)(2)) is amended by inserting ``, drug,''
after ``device''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to submissions made on or after the date of the enactment of this
Act.
SEC. 404. SUBPOENA AUTHORITY.
(a) Prohibited Act.--Section 301(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(f)) is amended by inserting before the
period ``or the failure or refusal to obey a subpoena issued pursuant
to section 312''.
(b) Exercise of Subpoena Authority.--Chapter III of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.), as amended, is
further amended by adding at the end the following new section:
``SEC. 312. EXERCISE OF SUBPOENA AUTHORITY.
``(a) In General.--For the purpose of--
``(1) any hearing, investigation, or other proceeding
respecting a violation of a provision of this Act, the Public
Health Service Act, or the Federal Anti-Tampering Act, relating
to a drug; or
``(2) any hearing, investigation, or other proceeding to
determine if a person is in violation of a specific provision
of this Act, the Public Health Service Act, or the Federal
Anti-Tampering Act, relating to a drug,
the Commissioner may issue subpoenas requiring the attendance and
testimony of witnesses and the production of records and other things.
``(b) Timing of Compliance.--When the Commissioner deems that
immediate compliance with a subpoena issued under this section is
necessary to address a threat of serious adverse health consequences or
death, the subpoena may require immediate production.
``(c) Service of Subpoena.--Under this section:
``(1) In general.--Subpoenas of the Commissioner shall be
served by a person authorized by the Commissioner by delivering
a copy thereof to the person named therein or by certified mail
addressed to such person at such person's last known dwelling
place or principal place of business.
``(2) Corporations and other entities.--Service on a
domestic or foreign corporation, partnership, unincorporated
association, or other entity that is subject to suit under a
common name may be made by delivering the subpoena to an
officer, a managing or general agent, or any other agent
authorized by appointment or by law to receive service of
process.
``(3) Person outside u.s. jurisdiction.--Service on any
person not found within the territorial jurisdiction of any
court of the United States may be made in any manner as the
Federal Rules of Civil Procedure prescribe for service in a
foreign nation.
``(4) Proof of service.--A verified return by the person so
serving the subpoena setting forth the manner of service, or,
in the case of service by certified mail, the return post
office receipt therefore signed by the person so served, shall
be proof of service.
``(d) Payment of Witnesses.--Witnesses subpoenaed under subsection
(a) shall be paid the same fees and mileage as are paid witnesses in
the district courts of the United States.
``(e) Enforcement.--In the case of a refusal to obey a subpoena
duly served upon any person under subsection (a), any district court of
the United States for the judicial district in which such person
charged with refusal to obey is found, resides, or transacts business,
upon application by the Commissioner, shall have jurisdiction to issue
an order compelling compliance with the subpoena and requiring such
person to appear and give testimony or to appear and produce records
and other things, or both. The failure to obey such order of the court
may be punished by the court as contempt thereof. If the person charged
with failure or refusal to obey is not found within the territorial
jurisdiction of the United States, the United States District Court for
the District of Columbia shall have the same jurisdiction, consistent
with due process, to take any action respecting compliance with the
subpoena by such person that such district court would have if such
person were personally within the jurisdiction of such district court.
``(f) Nondisclosure.--A United States district court for the
district in which the subpoena is or will be served, upon application
of the Commissioner, may issue an ex parte order that no person or
entity disclose to any other person or entity (other than to an
attorney to obtain legal advice) the existence of such subpoena for a
period of up to 90 days. Such order may be issued on a showing that the
records or things being sought may be relevant to the hearing,
investigation, proceeding, or other matter and that there is reason to
believe that such disclosure may result in--
``(1) furtherance of a potential violation under
investigation;
``(2) endangerment to the life or physical safety of any
person;
``(3) flight or other action to avoid prosecution or other
enforcement remedies;
``(4) destruction of or tampering with evidence; or
``(5) intimidation of potential witnesses.
An order under this subsection may be renewed for additional periods of
up to 90 days upon a showing that any of the circumstances described in
paragraphs (1) through (5) continue to exist.
``(g) Relation to Other Provisions.--The subpoena authority vested
in the Commissioner and the district courts of the United States by
this section is in addition to any such authority vested in the
Commissioner or such courts by other provisions of law, or as is
otherwise authorized by law.
``(h) Nondelegation.--The authority to issue a subpoena under this
section is limited to the Commissioner or an official designated by the
Commissioner. An official may not be so designated unless the official
is the director of the district under this Act in which the drug is
located, or is an official senior to such director.''.
(c) Failure To Obey Subpoena.--Section 801 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is further amended
by adding at the end the following new subsection:
``(u)(1) A drug shall be refused admission if any person who
manufactures, processes, packs, holds, or ships such drug before it is
imported or offered for import into the United States fails or refuses
to obey a subpoena issued pursuant to section 312 and such subpoena was
issued, in whole or in part, for the purpose of determining whether
such drug is adulterated, misbranded, or an unapproved new drug.
``(2) No drug shall be refused admission under this section based
on the failure or refusal to obey a subpoena that has been withdrawn by
the Commissioner or quashed by a United States district court.''.
SEC. 405. WHISTLEBLOWER PROTECTIONS.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.), as amended, is further amended by adding at the end the
following:
``SEC. 1013. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO
DISCLOSE VIOLATIONS OF, THIS ACT.
``(a) In General.--No person who submits or is required under this
Act or the Public Health Service Act to submit any information related
to a drug, or any officer, employee, contractor, subcontractor, or
agent of such person, may discharge, demote, suspend, threaten, harass,
or in any other manner discriminate against an employee in the terms
and conditions of employment because of any lawful act done by the
employee (including any lawful act that is within the ordinary course
of the job duties of such employee)--
``(1) to provide information, cause information to be
provided, or otherwise assist in any investigation regarding
any conduct which the employee reasonably believes constitutes
a violation of this Act that is related to a drug, or any other
provision of Federal law relating to the safety of a drug, if
the information or assistance is provided to, or an
investigation stemming from the provided information is
conducted by--
``(A) a Federal regulatory or law enforcement
agency;
``(B) any Member of Congress or any committee of
Congress; or
``(C) a person with supervisory authority over the
employee (or such other person working for the employer
who has the authority to investigate, discover, or
terminate the misconduct);
``(2) to file, cause to be filed, testify, participate in,
or otherwise assist in a proceeding filed, or about to be filed
(with any knowledge of the employer), in any court or
administrative forum relating to any such alleged violation; or
``(3) to refuse to commit or assist in any such violation.
``(b) Enforcement Action.--
``(1) In general.--An employee who alleges discharge or
other discrimination in violation of subsection (a) may seek
relief in accordance with the provisions of subsection (c) by--
``(A) filing a complaint with the Secretary of
Labor; or
``(B) if the Secretary of Labor has not issued a
final decision within 210 days of the filing of the
complaint and there is no showing that such delay is
due to the bad faith of the claimant, or within 90 days
after receiving a final decision or order from the
Secretary, bringing an action at law or equity for de
novo review in the appropriate district court of the
United States, which court shall have jurisdiction over
such action without regard to the amount in
controversy, and which action shall, at the request of
either party to such action, be tried by the court with
a jury.
``(2) Procedure.--
``(A) In general.--Any action under paragraph (1)
shall be governed under the rules and procedures set
forth in section 42121(b) of title 49, United States
Code.
``(B) Exception.--Notification in an action under
paragraph (1) shall be made in accordance with section
42121(b)(1) of title 49, United States Code, except
that such notification shall be made to the person
named in the complaint, the employer, and the
Commissioner of Food and Drugs.
``(C) Burdens of proof.--An action brought under
paragraph (1)(A) or (1)(B) shall be governed by the
legal burdens of proof set forth in section 42121(b) of
title 49, United States Code.
``(D) Statute of limitations.--An action under
paragraph (1)(A) shall be commenced not later than 180
days after the date on which the violation occurs.
``(c) Remedies.--
``(1) In general.--An employee prevailing in any action
under subsection (b)(1) shall be entitled to all relief
necessary to make the employee whole.
``(2) Issuance of order.--If, in response to a complaint
filed under subsection (b)(1), the Secretary of Labor or the
district court, as applicable, determines that a violation of
subsection (a) has occurred, the Secretary or the court shall
order the person who committed such violation--
``(A) to take affirmative action to abate the
violation;
``(B) to--
``(i) reinstate the complainant to his or
her former position together with compensation
(including backpay); and
``(ii) restore the terms, conditions, and
privileges associated with his or her
employment; and
``(C) to provide compensatory damages to the
complainant.
If such an order is issued under this paragraph, the Secretary
or the court, at the request of the complainant, shall assess
against the person against whom the order is issued a sum equal
to the aggregate amount of all costs and expenses (including
attorney and expert witness fees) reasonably incurred, as
determined by the Secretary, by the complainant for, or in
connection with, the bringing of the complaint upon which the
order was issued.
``(d) Rights Retained by Employee.--Nothing in this section shall
be deemed to diminish the rights, privileges, or remedies of any
employee under any Federal or State law or under any collective
bargaining agreement. The rights and remedies in this section may not
be waived by any agreement, policy, form, or condition of
employment.''.
SEC. 406. RULE OF CONSTRUCTION.
Nothing in this Act or any amendment made by this Act shall be
construed as affecting any authority or requirement relating to devices
(as defined in section 201 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321)).
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