1.This Act may be cited as the
Pharmaceutical Market Access Act of
2007
.
2.Congress finds as follows:
(1)Americans unjustly
pay up to 1,000 percent more to fill their prescriptions than consumers in
other countries.
(2)The United States
is the world’s largest market for pharmaceuticals yet consumers still pay the
world’s highest prices.
(3)An unaffordable
drug is neither safe nor effective. Allowing and structuring the importation of
prescription drugs ensures access to affordable drugs, thus providing a level
of safety to American consumers they do not currently enjoy.
(4)Prescription drug
costs are a leading cause of the growth in United States health care spending,
which reached nearly $2,000,000,0000 in 2005, of which spending on prescription
drugs amounted to $200,700,000,000.
(5)According to the
Congressional Budget Office, American seniors alone will spend
$1,800,000,000,000 on pharmaceuticals over the next 10 years.
(6)Allowing open
pharmaceutical markets could save American consumers at least $635,000,000,000
of their own money.
3.The purposes of this Act to—
(1)give all
Americans immediate relief from the outrageously high cost of
pharmaceuticals;
(2)reverse the
perverse economics of the American pharmaceutical market;
(3)allow the
importation of prescription drugs only if the drugs and facilities where such
drugs are manufactured are approved by the Food and Drug Administration, and to
exclude pharmaceutical narcotics;
(4)ensure continued
integrity to the prescription drug supply of the United States by—
(A)requiring that
imported prescription drugs be packaged and shipped using counterfeit-resistant
technologies;
(B)requiring
Internet pharmacies to register with the United States Government for Americans
to verify authenticity before purchases over the Internet;
(C)requiring all
foreign sellers to register with United States Government and submit to
facility inspections by the Government without prior notice; and
(D)limiting the
eligible countries from which prescription drugs may be imported to Canada,
member countries of the European Union, and other highly industrialized nations
with safe pharmaceutical infrastructures.
4.Amendments to
section 804 of the Federal food, drug, and cosmetic act
(a)Section
804(a) of the Federal Food, Drug, and Cosmetic
Act (21
U.S.C. 384(a)) is amended to read as follows:
(a)In
this section:
(1)The
term importer means a pharmacy, group of pharmacies, pharmacist,
or wholesaler.
(2)The term permitted country means Australia,
Canada, Israel, Japan, New Zealand, Switzerland, South Africa, Austria,
Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg,
Netherlands, Portugal, Spain, Sweden, the United Kingdom, Iceland,
Liechtenstein, and Norway, except that the Secretary—
(A)may add a country,
union, or economic area as a permitted country for purposes of this section if
the Secretary determines that the country, union, or economic area has a
pharmaceutical infrastructure that is substantially equivalent or superior to
the pharmaceutical infrastructure of the United States, taking into
consideration pharmacist qualifications, pharmacy storage procedures, the drug
distribution system, the drug dispensing system, and market regulation;
and
(B)may remove a
country, union, or economic area as a permitted country for purposes of this
section if the Secretary determines that the country, union, or economic area
does not have such a pharmaceutical infrastructure.
(3)The
term pharmacist means a person licensed by the relevant
governmental authority to practice pharmacy, including the dispensing and
selling of prescription drugs.
(4)The
term pharmacy means a person that is licensed by the relevant
governmental authority to engage in the business of selling prescription drugs
that employs 1 or more pharmacists.
(5)The term prescription drug means a drug subject
to section 503(b), other than—
(A)a controlled
substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C.
802));
(B)a biological
product (as defined in section 351 of the Public
Health Service Act (42 U.S.C. 262));
(C)an infused drug
(including a peritoneal dialysis solution);
(D)an intravenously
injected drug;
(E)a drug that is
inhaled during surgery; or
(F)a drug which is a
parenteral drug, the importation of which pursuant to subsection (b) is
determined by the Secretary to pose a threat to the public health, in which
case section 801(d)(1) shall continue to apply.
(6)The term qualifying drug means a prescription
drug that—
(A)is approved
pursuant to an application submitted under section 505(b)(1); and
(B)is not—
(i)a
drug manufactured through 1 or more biotechnology processes;
(ii)a
drug that is required to be refrigerated; or
(iii)a photoreactive
drug.
(7)Qualifying
Internet pharmacyThe term qualifying Internet
pharmacy means a registered exporter that dispenses qualifying drugs to
individuals over an Internet website.
(8)The term qualifying laboratory means a
laboratory in the United States that has been approved by the Secretary for the
purposes of this section.
(9)The term registered exporter means a person
that is in the business of exporting a drug to persons in the United States (or
that seeks to be in such business), for which a registration under this section
has been approved and is in effect.
(10)
(A)The term wholesaler means a person licensed
as a wholesaler or distributor of prescription drugs in the United States under
section 503(e)(2)(A).
(B)The
term wholesaler does not include a person authorized to import
drugs under section
801(d)(1).
.
(b)Section
804(b) of the Federal Food, Drug, and Cosmetic
Act (21
U.S.C. 384(b)) is amended to read as follows:
(b)Not
later than 180 days after the date of enactment of the
Pharmaceutical Market Access Act of
2007, the Secretary, after consultation with the United States
Trade Representative and the Commissioner of the Bureau of Customs and Border
Protection, shall promulgate regulations permitting pharmacists, pharmacies,
and wholesalers to import qualifying drugs from permitted countries into the
United
States.
.
(c)Section
804(c) of the Federal Food, Drug, and Cosmetic
Act (21
U.S.C. 384(c)) is amended by striking prescription
drug
each place it appears and inserting qualifying
drug
.
(d)Section 804(d)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
384(d)(1)) is amended—
(1)by striking
subparagraph (G) and redesignating subparagraphs (H) through (N) as
subparagraphs (G) through (M), respectively;
(2)in subparagraph
(H) (as so redesignated), by striking telephone number, and professional
license number (if any)
and inserting and telephone
number
; and
(3)in subparagraph
(L) (as so redesignated), by striking (J) and (L)
and inserting
(I) and (K)
.
(e)Section
804(e) of the Federal Food, Drug, and Cosmetic
Act (21
U.S.C. 384(e)) is amended to read as follows:
(e)The
regulations under subsection (b) shall require that the testing described under
subparagraphs (I) and (K) of subsection (d)(1) be conducted by the importer of
the qualifying drug, unless the qualifying drug is subject to the requirements
under section 505C for counterfeit-resistant
technologies.
.
(f)Registration of
exporters; inspectionsSection 804(f) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
384(f)) is amended to read as follows:
(f)Registration of
exporters; inspections
(1)Any person that seeks to be a registered exporter
(referred to in this subsection as the registrant
) shall submit
to the Secretary a registration that includes the following:
(A)The name of the
registrant and identification of all places of business of the registrant that
relate to qualifying drugs, including each warehouse or other facility owned or
controlled by, or operated for, the registrant;
(B)An agreement by
the registrant to—
(i)make its places of
business that relate to qualifying drugs (including warehouses and other
facilities owned or controlled by, or operated for, the exporter) and records
available to the Secretary for on-site inspections, without prior notice, for
the purpose of determining whether the registrant is in compliance with this
Act’s requirements;
(ii)export only
qualifying drugs;
(iii)export only to
persons authorized to import the drugs;
(iv)notify the
Secretary of a recall or withdrawal of a qualifying drug distributed in a
permitted country to or from which the registrant has exported or imported, or
intends to export or import, to the United States;
(v)monitor compliance
with registration conditions and report any noncompliance promptly;
(vi)submit a
compliance plan showing how the registrant will correct violations, if any;
and
(vii)promptly notify
the Secretary of changes in the registration information of the
registrant.
(2)Notice of approval
or disapproval
(A)Not later than 90 days after receiving a completed
registration from a registrant, the Secretary shall—
(i)notify such
registrant of receipt of the registration;
(ii)assign such
registrant a registration number; and
(iii)approve or
disapprove the application.
(B)Disapproval of
application
(i)The Secretary shall disapprove a registration, and notify
the registrant of such disapproval, if the Secretary has reason to believe that
such registrant is not in compliance with a registration condition.
(ii)The Secretary may subsequently approve a registration
that was denied under clause (i) if the Secretary finds that the registrant is
in compliance with all registration conditions.
(3)The
Secretary shall—
(A)maintain an
up-to-date list of registered exporters (including qualifying Internet
pharmacies that sell qualifying drugs to individuals);
(B)make such list
available to the public on the Internet site of the Food and Drug
Administration and via a toll-free telephone number; and
(C)update such list
promptly after the approval of a registration under this subsection.
(4)The Secretary shall carry out activities, by use of the
Internet website and toll-free telephone number under paragraph (3), that
educate consumers with regard to the availability of qualifying drugs for
import for personal use under this section, including information on how to
verify whether an exporter is registered.
(5)Inspection of
importers and registered exportersThe Secretary shall inspect
the warehouses, other facilities, and records of importers and registered
exporters as often as the Secretary determines necessary to ensure that such
importers and registered exporters are in compliance with this
section.
.
(g)Suspension of
ImportationSection 804(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
384(g)) is amended by—
(1)striking
and the Secretary determines that the public is adequately protected
from counterfeit and violative prescription drugs being imported under
subsection (b)
; and
(2)by adding after
the period at the end the following: The Secretary shall reinstate the
importation by a specific importer upon a determination by the Secretary that
the violation has been corrected and that the importer has demonstrated that
further violations will not occur. This subsection shall not apply to a
prescription drug imported by an individual, or to a prescription drug shipped
to an individual by a qualifying Internet pharmacy.
.
(h)Waiver authority
for individualsSection 804(j) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
384(j)) is amended to read as follows:
(j)Importation by
individuals
(1)Not later than 180 days after the enactment of the
Pharmaceutical Market Access Act of
2007, the Secretary shall by regulation permit an individual to
import a drug from a permitted country to the United States if the drug
is—
(A)a qualifying
drug;
(B)imported from a
licensed pharmacy or qualifying Internet pharmacy;
(C)for personal use
by an individual, or family member of the individual, not for resale;
(D)in a quantity that
does not exceed a 90-day supply during any 90-day period; and
(E)accompanied by a
copy of a prescription for the drug, which—
(i)is
valid under applicable Federal and State laws; and
(ii)was issued by a
practitioner who is authorized to administer prescription drugs.
(2)Drugs dispensed
outside the United StatesAn individual may import a drug from a
country that is not a permitted country if—
(A)the drug was
dispensed to the individual while the individual was in such country, and the
drug was dispensed in accordance with the laws and regulations of such
country;
(B)the individual is
entering the United States and the drug accompanies the individual at the time
of entry;
(C)the drug is
approved for commercial distribution in the country in which the drug was
obtained;
(D)the drug does not
appear to be adulterated; and
(E)the quantity of
the drug does not exceed a 14-day
supply.
.
(i)Repeal of certain
provisionsSection 804 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
384) is amended by striking subsections (l) and (m).
5.Subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic
Act (21
U.S.C. 397f et seq.) is amended by adding at the end the
following:
5Fees
relating to prescription drug importation
740A.Fees relating
to prescription drug importation
(a)The Secretary shall establish a registration fee program
under which a registered exporter under section 804 shall be required to pay an
annual fee to the Secretary in accordance with this subsection.
(b)
(1)Collection on
initial registrationA fee under this section shall be payable
for the fiscal year in which the registered exporter first submits a
registration under section 804 (or reregisters under that section if that
person has withdrawn its registration and subsequently reregisters) in a amount
of $10,000, due on the date the exporter first submits a registration to the
Secretary under section 804.
(2)Collection in
subsequent yearsAfter the fee is paid for the first fiscal year,
the fee described under this subsection shall be payable on or before October 1
of each year.
(3)The fee shall be paid only once for each registered
exporter for a fiscal year in which the fee is payable.
(c)
(1)Subject to subsection (b)(1), the amount of the fee shall
be determined each year by the Secretary and shall be based on the anticipated
costs to the Secretary of enforcing the amendments made by the
Pharmaceutical Market Access Act of
2007 in the subsequent fiscal year.
(2)
(A)The aggregate total of fees collected under this section
shall not exceed 1 percent of the total price of drugs exported annually to the
United States by registered exporters under this section.
(B)Subject to the limitation described in subparagraph (A),
a fee under this subsection for an exporter shall be an amount that is a
reasonable estimate by the Secretary of the annual share of the exporter of the
volume of drugs exported by exporters under this section.
(d)The fees collected under this section shall be used for the
sole purpose of administering this section with respect to registered
exporters, including the costs associated with—
(1)inspecting the
facilities of registered exporters, and of other entities in the chain of
custody of a qualifying drug;
(2)developing,
implementing, and maintaining a system to determine registered exporters’
compliance with the registration conditions under the
Pharmaceutical Market Access Act of
2007, including when shipments of qualifying drugs are offered
for import into the United States; and
(3)inspecting such
shipments, as necessary, when offered for import into the United States to
determine if any such shipment should be refused admission.
(e)The Secretary shall establish, 60 days before the
beginning of each fiscal year beginning after September 30, 2007, for that
fiscal year, registration fees.
(f)Effect of
failure to pay fees
(1)A fee payable under this section shall be paid by the date
that is 30 days after the date on which the fee is due.
(2)If a registered exporter subject to a fee under this section
fails to pay the fee, the Secretary shall not permit the registered exporter to
engage in exportation to the United States or offering for exportation
prescription drugs under this Act until all such fees owed by that person are
paid.
(g)
(1)Not later than 60 days before the beginning of each
fiscal year, the Secretary shall—
(A)publish
registration fees under this section for that fiscal year;
(B)hold a meeting at
which the public may comment on the recommendations; and
(C)provide for a
period of 30 days for the public to provide written comments on the
recommendations.
(2)Performance and
fiscal reportBeginning with fiscal year 2007, not later than 60
days after the end of each fiscal year during which fees are collected under
this section, the Secretary shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives a report that describes—
(A)implementation of
the registration fee authority during the fiscal year; and
(B)the use by the
Secretary of the fees collected during the fiscal year for which the report is
made.
.
6.Counterfeit-resistant
technology
(a)Section
502 of the Federal Food, Drug, and Cosmetic
Act (21
U.S.C. 352; deeming drugs and devices to be misbranded) is
amended by adding at the end the following:
(x)If it is a drug
subject to section 503(b), unless the packaging of such drug complies with the
requirements of section 505C for counterfeit-resistant
technologies.
.
(b)Chapter
V of the Federal Food, Drug, and Cosmetic
Act (21
U.S.C. 351 et seq.) is amended by inserting after section 505B
the following:
505C.Counterfeit-resistant
technologies
(a)Incorporation of
counterfeit-resistant technologies into prescription drug
packagingThe Secretary shall require that the packaging of any
drug subject to section 503(b) incorporate—
(1)overt optically
variable counterfeit-resistant technologies that are described in subsection
(b) and comply with the standards of subsection (c); or
(2)technologies that
have an equivalent function of security, as determined by the Secretary.
(b)Technologies described in this subsection—
(1)shall be visible
to the naked eye, providing for visual identification of product authenticity
without the need for readers, microscopes, lighting devices, or
scanners;
(2)shall be similar
to that used by the Bureau of Engraving and Printing to secure United States
currency;
(3)shall be
manufactured and distributed in a highly secure, tightly controlled
environment; and
(4)should incorporate
additional layers of non-visible covert security features up to and including
forensic capability.
(c)
(1)For the purpose of making it more difficult to
counterfeit the packaging of drugs subject to section 503(b), manufacturers of
the drugs shall incorporate the technologies described in subsection (b) into
multiple elements of the physical packaging of the drugs, including blister
packs, shrink wrap, package labels, package seals, bottles, and boxes.
(2)Labeling of
shipping containerShipments of drugs described in subsection (a)
shall include a label on the shipping container that incorporates the
technologies described in subsection (b), so that officials inspecting the
packages will be able to determine the authenticity of the shipment. Chain of
custody procedures shall apply to such labels and shall include procedures
applicable to contractual agreements for the use and distribution of the
labels, methods to audit the use of the labels, and database access for the
relevant governmental agencies for audit or verification of the use and
distribution of the labels.
(d)This section shall take effect 180 days after the date of
enactment of the Pharmaceutical Market Access
Act of
2007.
.
7.Section 301 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
331) is amended by inserting after subsection (k) the
following:
(l)The failure to
register in accordance with section 804(f) or to import or offer to import a
prescription drug in violation of a suspension order under section
804(g).
.
8.Section 271 of title
35, United States Code, is amended—
(1)by
redesignating subsections (h) and (i) as subsections (i) and (j), respectively;
and
(2)by inserting after
subsection (g) the following:
(h)It shall not be an
act of infringement to use, offer to sell, or sell within the United States or
to import into the United States any patented invention under section 804
(21 U.S.C.
384) of the Federal Food, Drug,
and Cosmetic Act that was first sold abroad by or under authority of
the owner or licensee of such
patent.
.
9.Other enforcement
actions
(a)Section 804 of the Federal Food, Drug, and Cosmetic Act (as
amended in section 4) is amended by adding at the end the following:
(l)Unfair or
discriminatory Acts and practices
(1)It is unlawful for a manufacturer, directly or indirectly
(including by being a party to a licensing or other agreement) to—
(A)discriminate by
charging a higher price for a prescription drug sold to a person in a permitted
country that exports a prescription drug to the United States under this
section than the price that is charged to another person that is in the same
country and that does not export a prescription drug into the United States
under this section;
(B)discriminate by
charging a higher price for a prescription drug sold to a person that
distributes, sells, or uses a prescription drug imported into the United States
under this section than the price that is charged to another person in the
United States that does not import a prescription drug under this section, or
that does not distribute, sell, or use such a drug;
(C)discriminate by
denying supplies of a prescription drug to a person in a permitted country that
exports a prescription drug to the United States under this section or
distributes, sells, or uses a prescription drug imported into the United States
under this section;
(D)discriminate by
publicly, privately, or otherwise refusing to do business with a person in a
permitted country that exports a prescription drug to the United States under
this section or distributes, sells, or uses a prescription drug imported into
the United States under this section;
(E)discriminate by
specifically restricting or delaying the supply of a prescription drug to a
person in a permitted country that exports a prescription drug to the United
States under this section or distributes, sells, or uses a prescription drug
imported into the United States under this section;
(F)cause there to be
a difference (including a difference in active ingredient, route of
administration, dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that manufactures the drug)
between a prescription drug for distribution in the United States and the drug
for distribution in a permitted country for the purpose of restricting
importation of the drug into the United States under this section;
(G)refuse to allow an
inspection authorized under this section of an establishment that manufactures
a prescription drug that may be imported or offered for import under this
section;
(H)fail to conform to
the methods used in, or the facilities used for, the manufacturing, processing,
packing, or holding of a prescription drug that may be imported or offered for
import under this section to good manufacturing practice under this Act;
(I)become a party to a
licensing or other agreement related to a prescription drug that fails to
provide for compliance with all requirements of this section with respect to
such prescription drug or that has the effect of prohibiting importation of the
drug under this section; or
(J)engage in any other
action that the Federal Trade Commission determines to discriminate against a
person that engages in, or to impede, delay, or block the process for, the
importation of a prescription drug under this section.
(2)It shall be an affirmative defense to a charge that a
person has discriminated under subparagraph (A), (B), (C), (D), or (E) of
paragraph (1) that the higher price charged for a prescription drug sold to a
person, the denial of supplies of a prescription drug to a person, the refusal
to do business with a person, or the specific restriction or delay of supplies
to a person is not based, in whole or in part, on—
(A)the person
exporting or importing a prescription drug into the United States under this
section; or
(B)the person
distributing, selling, or using a prescription drug imported into the United
States under this section.
(3)Presumption and
affirmative defense
(A)A
difference (including a difference in active ingredient, route of
administration, dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that manufactures the drug)
created after January 1, 2007, between a prescription drug for distribution in
the United States and the drug for distribution in a permitted country shall be
presumed under paragraph (1)(H) to be for the purpose of restricting
importation of the drug into the United States under this section.
(B)It shall be an affirmative defense to the presumption
under subparagraph (A) that—
(i)the
difference was required by the country in which the drug is distributed;
or
(ii)the Secretary has
determined that the difference was necessary to improve the safety or
effectiveness of the drug.
(4)
(A)This subsection applies only to the sale or
distribution of a prescription drug in a country if the manufacturer of the
drug chooses to sell or distribute the drug in the country. Nothing in this
subsection shall be construed to compel the manufacturer of a drug to
distribute or sell the drug in a country.
(B)Discounts to
insurers, health plans, pharmacy benefit managers, and covered
entitiesNothing in this subsection shall be construed to—
(i)prevent or
restrict a manufacturer of a prescription drug from providing discounts to an
insurer, health plan, pharmacy benefit manager in the United States, or covered
entity in the drug discount program under section 340B in return for inclusion
of the drug on a formulary;
(ii)require that such
discounts be made available to other purchasers of the prescription drug;
or
(iii)prevent or
restrict any other measures taken by an insurer, health plan, or pharmacy
benefit manager to encourage consumption of such prescription drug.
(C)Nothing in this subsection shall be construed
to—
(i)prevent a
manufacturer from donating a prescription drug, or supplying a prescription
drug at nominal cost, to a charitable or humanitarian organization, including
the United Nations and affiliates, or to a government of a foreign country;
or
(ii)apply to such
donations or supplying of a prescription drug.
(5)
(A)Unfair or
deceptive Act or practiceA violation of this subsection shall be
treated as a violation of a rule defining an unfair or deceptive act or
practice prescribed under section 18(a)(1)(B) of the
Federal Trade Commission Act.
(B)Actions by the
CommissionThe Federal Trade Commission—
(i)shall enforce this
subsection in the same manner, by the same means, and with the same
jurisdiction, powers, and duties as though all applicable terms and provisions
of the Federal Trade Commission Act
were incorporated into and made a part of this section; and
(ii)may seek monetary
relief threefold the damages sustained.
(6)
(A)
(i)The attorney general of a State may bring a civil action
on behalf of the residents of the State, and persons doing business in the
State, in a district court of the United States of appropriate jurisdiction for
a violation of paragraph (1) to—
(I)enjoin that
practice;
(II)enforce
compliance with this subsection;
(III)obtain damages,
restitution, or other compensation on behalf of residents of the State and
persons doing business in the State, including threefold the damages; or
(IV)obtain such other
relief as the court may consider to be appropriate.
(ii)
(I)Before filing an action under clause (i), the attorney
general of the State involved shall provide to the Federal Trade
Commission—
- (aa)written notice of
that action; and
- (bb)a
copy of the complaint for that action.
(II)Subclause
(I) shall not apply with respect to the filing of an action by an attorney
general of a State under this paragraph, if the attorney general determines
that it is not feasible to provide the notice described in that subclause
before filing of the action. In such case, the attorney general of a State
shall provide notice and a copy of the complaint to the Federal Trade
Commission at the same time as the attorney general files the action.
(B)
(i)On receiving notice under subparagraph (A)(ii), the
Commission shall have the right to intervene in the action that is the subject
of the notice.
(ii)If the Commission intervenes in an action under
subparagraph (A), it shall have the right—
(I)to be heard with
respect to any matter that arises in that action; and
(II)to file a
petition for appeal.
(C)For
purposes of bringing any civil action under subparagraph (A), nothing in this
subsection shall be construed to prevent an attorney general of a State from
exercising the powers conferred on the attorney general by the laws of that
State to—
(i)conduct
investigations;
(ii)administer oaths
or affirmations; or
(iii)compel the
attendance of witnesses or the production of documentary and other
evidence.
(D)Actions by the
Commission
(i)In any case in which an action is instituted by or on
behalf of the Commission for a violation of paragraph (1), a State may not,
during the pendency of that action, institute an action under subparagraph (A)
for the same violation against any defendant named in the complaint in that
action.
(ii)An
attorney general of a State may intervene, on behalf of the residents of that
State, in an action instituted by the Commission.
(iii)If an attorney general of a State intervenes in an
action instituted by the Commission, such attorney general shall have the
right—
(I)to be heard with
respect to any matter that arises in that action; and
(II)to file a
petition for appeal.
(E)Any
action brought under subparagraph (A) may be brought in the district court of
the United States that meets applicable requirements relating to venue under
section
1391 of title 28, United States Code.
(F)In an action brought under subparagraph (A), process may
be served in any district in which the defendant—
(i)is
an inhabitant; or
(ii)may be
found.
(G)Any action under this paragraph to enforce a cause of
action under this subsection by the Federal Trade Commission or the attorney
general of a State shall be forever barred unless commenced within 5 years
after the Federal Trade Commission, or the attorney general, as the case may
be, knew or should have known that the cause of action accrued. No cause of
action barred under existing law on the effective date of the Pharmaceutical
Market Access Act of 2007 shall be revived by such Act.
(H)In any action under this paragraph to enforce a cause of
action under this subsection in which there has been a determination that a
defendant has violated a provision of this subsection, damages may be proved
and assessed in the aggregate by statistical or sampling methods, by the
computation of illegal overcharges or by such other reasonable system of
estimating aggregate damages as the court in its discretion may permit without
the necessity of separately proving the individual claim of, or amount of
damage to, persons on whose behalf the suit was brought.
(I)Exclusion on
duplicative reliefThe district court shall exclude from the
amount of monetary relief awarded in an action under this paragraph brought by
the attorney general of a State any amount of monetary relief which duplicates
amounts which have been awarded for the same injury.
(7)Nothing in this subsection shall be construed to
modify, impair, or supersede the operation of the antitrust laws. For the
purpose of this subsection, the term antitrust laws has the
meaning given it in the first section of the Clayton Act, except that it includes section 5
of the Federal Trade Commission Act
to the extent that such section 5 applies to unfair methods of
competition.
(8)In
this subsection, the term manufacturer means any entity, including
any affiliate or licensee of that entity, that is engaged in—
(A)the production,
preparation, propagation, compounding, conversion, or processing of a
prescription drug, either directly or indirectly by extraction from substances
of natural origin, or independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis; or
(B)the packaging,
repackaging, labeling, relabeling, or distribution of a prescription
drug.
.
(b)The
Federal Trade Commission shall promulgate regulations to carry out the
enforcement program under section 804(l) of the Federal Food, Drug, and Cosmetic Act (as added
by subsection (a)).
(c)Suspension and
termination of exportersSection 804(g) of the
Federal Food, Drug, and Cosmetic Act
(as amended by section 4(g)) (21 U.S.C. 384(g)) is amended
by—
(1)striking
Suspension of
Importation.—The Secretary
and
inserting
Suspension of
Importation.—(1)The Secretary
;
and
(2)adding at the end
the following:
(2)Suspension and
termination of exporters
(A)With
respect to the effectiveness of a registration submitted under subsection (f)
by a registered exporter:
(i)Subject to clause
(ii), if the Secretary determines, after notice and opportunity for a hearing,
that the registered exporter has failed to maintain substantial compliance with
all registration conditions, the Secretary may suspend the registration.
(ii)If the Secretary
determines that, under color of the registration, the registered exporter has
exported a drug that is not a qualifying drug, or a drug that does not meet the
criteria under this section, or has exported a qualifying drug to an individual
in violation of this section, the Secretary shall immediately suspend the
registration. A suspension under the preceding sentence is not subject to the
provision by the Secretary of prior notice, and the Secretary shall provide to
the registered exporter involved an opportunity for a hearing not later than 10
days after the date on which the registration is suspended.
(iii)The Secretary
may reinstate the registration, whether suspended under clause (i) or (ii), if
the Secretary determines that the registered exporter has demonstrated that
further violations of registration conditions will not occur.
(B)The
Secretary, after notice and opportunity for a hearing, may terminate the
registration under subsection (f) of a registered exporter if the Secretary
determines that the registered exporter has engaged in a pattern or practice of
violating 1 or more registration conditions, or if on 1 or more occasions the
Secretary has under subparagraph (A)(ii) suspended the registration of the
registered exporter. The Secretary may make the termination permanent, or for a
fixed period of not less than 1 year. During the period in which the
registration of a registered exporter is terminated, any registration submitted
under subsection (f) by such exporter or a person who is a partner in the
export enterprise or a principal officer in such enterprise, and any
registration prepared with the assistance of such exporter or such a person,
has no legal effect under this
section.
.
10.Authorization of
appropriationsThere are
authorized to be appropriated such sums as may be necessary to carry out this
Act (and the amendments made by this Act).