Pharmaceutical Market Access Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations permitting pharmacists, pharmacies, wholesalers, and individuals to import qualifying drugs from certain countries into the United States.
Sets forth registration requirements for exporters.
Requires the Secretary to: (1) educate consumers with regard to the availability of qualifying drugs for import for personal use; (2) inspect the facilities and records of importers and registered exporters to ensure compliance with this Act; and (3) establish a registration fee program to collect an annual fee from registered exporters.
Deems a prescription drug to be misbranded unless the packaging of such drug complies with the requirements for counterfeit-resistant technologies.
Prohibits: (1) failing to register in accordance with this Act; and (2) importing or offering to import a prescription drug in violation of a suspension order.
Declares that selling or importing a patented drug in the United States that was first sold abroad by or under authority of the owner or licensee of the patent is not patent infringement.
Prohibits drug manufacturers from discriminating against a person that engages in the importation of a prescription drug, including by charging higher prices or denying supplies of the drug.
Allows the Secretary to suspend or terminate the registration of an exporter for failing to maintain substantial compliance with all registration conditions.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 328 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 328
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
importation of prescription drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 25, 2005
Mr. Gutknecht (for himself, Mr. Emanuel, Mrs. Emerson, Mr. Sanders, Ms.
DeLauro, Mrs. Northup, Mr. Burton of Indiana, Ms. Ginny Brown-Waite of
Florida, Mr. Jones of North Carolina, Mr. Brown of Ohio, Mr. Istook,
Mr. Kingston, Mr. Ramstad, Mr. King of Iowa, and Mr. Langevin)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on the Judiciary,
for a period to be subsequently determined by the Speaker, in each case
for consideration of such provisions as fall within the jurisdiction of
the committee concerned
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
importation of prescription 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 ``Pharmaceutical Market Access Act of
2005''.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) Americans unjustly pay up to 1000 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) According to the Congressional Budget Office, American
seniors alone will spend $1,800,000,000,000 on pharmaceuticals
over the next 10 years.
(5) Allowing open pharmaceutical markets could save
American consumers at least $635,000,000,000 of their own
money.
SEC. 3. PURPOSES.
The purposes of this Act are as follows:
(1) To give all Americans immediate relief from the
outrageously high cost of pharmaceuticals.
(2) To reverse the perverse economics of the American
pharmaceutical market.
(3) To 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) To require that imported prescription drugs be packaged
and shipped using counterfeit-resistant technologies.
SEC. 4. AMENDMENTS TO SECTION 804 OF THE FEDERAL FOOD, DRUG, AND
COSMETIC.
(a) Definitions.--Section 804(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384(a)) is amended to read as follows:
``(a) Definitions.--In this section:
``(1) Importer.--The term `importer' means a pharmacy,
group of pharmacies, pharmacist, or wholesaler.
``(2) Permitted country.--The term `permitted country'
means a country, union, or economic area that is listed in
subparagraph (A) of section 802(b)(1) (as of December 31,
2003), except that the Secretary--
``(A) may add a country, union, or economic area to
such list 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
from such list for purposes of this section if the
Secretary determines that the country, union, or
economic area does not have such a pharmaceutical
infrastructure.
``(3) Pharmacist.--The term `pharmacist' means a person
licensed by the relevant governmental authority to practice
pharmacy, including the dispensing and selling of prescription
drugs.
``(4) Pharmacy.--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) Prescription drug.--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) Qualifying drug.--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 pharmacy.--The term `qualifying
Internet pharmacy' means a registered exporter that dispenses
qualifying drugs to individuals over an Internet website.
``(8) Qualifying laboratory.--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) Registered exporter.--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) Wholesaler.--
``(A) In general.--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) Exclusion.--The term `wholesaler' does not
include a person authorized to import drugs under
section 801(d)(1).''.
(b) Regulations.--Section 804(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384(b)) is amended to read as follows:
``(b) Regulations.--Not later than 180 days after the date of
enactment of the Pharmaceutical Market Access Act of 2005, the
Secretary, after consultation with the United States Trade
Representative and the Commissioner of Customs, shall promulgate
regulations permitting pharmacists, pharmacies, and wholesalers to
import qualifying drugs from permitted countries into the United
States.''.
(c) Limitation.--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) Information and Records.--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) Testing.--Section 804(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384(e)) is amended to read as follows:
``(e) Testing.--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; Inspections.--Section 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) In general.--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) In general.--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
``(ii) approve or disapprove the
application.
``(B) Disapproval of application.--
``(i) In general.--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) Subsequent approval.--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) List.--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) Education of consumers.--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 exporters.--
The 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 Importation.--Section 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 Individuals.--Section 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) In general.--Not later than 180 days after the
enactment of the Pharmaceutical Market Access Act of 2005, 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 states.--An
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 Provisions.--Section 804 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384) is amended by striking
subsections (l) and (m).
SEC. 5. REGISTRATION FEES.
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:
``PART 5--FEES RELATING TO PRESCRIPTION DRUG IMPORTATION
``SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IMPORTATION.
``(a) Registration Fee.--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) Collection.--
``(1) Collection on initial registration.--A 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 years.--After 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) One fee per facility.--The fee shall be paid only
once for each registered exporter for a fiscal year in which
the fee is payable.
``(c) Fee Amount.--
``(1) In general.--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 2005 in the subsequent fiscal year.
``(2) Limitation.--
``(A) In general.--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) Reasonable estimate.--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) Use of Fees.--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 2005, 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) Annual Fee Setting.--The Secretary shall establish, 60 days
before the beginning of each fiscal year beginning after September 30,
2005, for that fiscal year, registration fees.
``(f) Effect of Failure to Pay Fees.--
``(1) Due date.--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) Failure to pay.--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) Reports.--
``(1) Fee establishment.--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 report.--Beginning with fiscal
year 2005, 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.''.
SEC. 6. COUNTERFEIT-RESISTANT TECHNOLOGY.
(a) Misbranding.--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) Requirements.--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:
``SEC. 505C. COUNTERFEIT-RESISTANT TECHNOLOGIES.
``(a) Incorporation of Counterfeit-Resistant Technologies Into
Prescription Drug Packaging.--The 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) Eligible Technologies.--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) Standards for Packaging.--
``(1) Multiple elements.--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 container.--Shipments 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) Effective Date.--This section shall take effect 180 days
after the date of enactment of the Pharmaceutical Market Access Act of
2005.''.
SEC. 7. PROHIBITED ACTS.
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).''.
SEC. 8. PATENTS.
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.''.
SEC. 9. OTHER ENFORCEMENT ACTIONS.
(a) In General.--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) In general.--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) Affirmative defense.--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) Presumption.--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, 2005, 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) Affirmative defense.--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) Effect of subsection.--
``(A) Sales in other countries.--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 entities.--Nothing 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) Charitable contributions.--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) Enforcement.--
``(A) Unfair or deceptive act or practice.--A
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 commission.--The 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) Actions by states.--
``(A) In general.--
``(i) Civil actions.--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) Notice.--
``(I) In general.--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) Exemption.--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) Intervention.--
``(i) In general.--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) Effect of intervention.--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) Construction.--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 general.--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) Intervention.--An attorney general
of a State may intervene, on behalf of the
residents of that State, in an action
instituted by the Commission.
``(iii) Effect of intervention.--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) Venue.--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) Service of process.--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) Limitation of actions.--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 2005 shall be revived by such Act.
``(H) Measurement of damages.--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 relief.--The
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) Effect on antitrust laws.--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) Manufacturer.--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) Regulations.--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 Exporters.--Section 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) In general.--The Secretary''; and
(2) adding at the end the following:
``(2) Suspension and termination of exporters.--
``(A) Suspension.--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) Termination.--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.''.
SEC. 10. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as may be
necessary to carry out this Act (and the amendments made by this Act).
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Sponsor introductory remarks on measure. (CR H606)
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Sponsor introductory remarks on measure. (CR H1754)
Sponsor introductory remarks on measure. (CR H1945-1946)
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line
Sponsor introductory remarks on measure. (CR H3289-3290)
Sponsor introductory remarks on measure. (CR H3406-3407)
Sponsor introductory remarks on measure. (CR H4784-4785)
Sponsor introductory remarks on measure. (CR H4861)