‘‘(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.—Be-
ginning 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 Com-
mittee 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 re-
port 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 require-
ments of section 505C for counterfeit-resistant tech-
nologies.’’. 
(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
PACK-
AGING.—The Secretary shall require that the packaging 
of any drug subject to section 503(b) incorporate—
‘‘(1) overt optically variable counterfeit-resist-
ant technologies that are described in subsection (b) 
and comply with the standards of subsection (c); or 
‘‘(2) technologies that have an equivalent func-
tion of security, as determined by the Secretary. 
‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de-
scribed in this subsection—
‘‘(1) shall be visible to the naked eye, providing 
for visual identification of product authenticity with-
out the need for readers, microscopes, lighting de-
vices, 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 includ-
ing forensic capability. 
‘‘(c) STANDARDS FOR PACKAGING.—
‘‘(1) MULTIPLE ELEMENTS.—For the purpose 
of making it more difficult to counterfeit the pack-
aging of drugs subject to section 503(b), manufac-
turers 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 incor-
porates 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 ef-
fect 180 days after the date of enactment of the Pharma-
ceutical 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 sub-
section (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 fol-
lowing:
‘‘(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 sec-
tion 804 (21 U.S.C. 384) of the Federal Food, Drug, and 
Cosmetic Act that was first sold abroad by or under au-
thority 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 PRAC-
TICES.—
‘‘(1) IN GENERAL.—It is unlawful for a manu-
facturer, 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 sec-
tion, 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 prescrip-
tion drug to the United States under this sec-
tion 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 pre-
scription drug imported into the United States 
under this section; 
‘‘(F) cause there to be a difference (includ-
ing a difference in active ingredient, route of 
administration, dosage form, strength, formula-
tion, manufacturing establishment, manufac-
turing process, or person that manufactures the 
drug) between a prescription drug for distribu-
tion in the United States and the drug for dis-
tribution 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 author-
ized under this section of an establishment that 
manufactures a prescription drug that may be 
imported or offered for import under this sec-
tion; 
‘‘(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 im-
port 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 require-
ments of this section with respect to such pre-
scription drug or that has the effect of prohib-
iting importation of the drug under this section; 
or 
‘‘(J) engage in any other action that the 
Federal Trade Commission determines to dis-
criminate 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 spe-
cific 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
DE-
FENSE.—
‘‘(A) PRESUMPTION.—A difference (includ-
ing a difference in active ingredient, route of 
administration, dosage form, strength, formula-
tion, manufacturing establishment, manufac-
turing 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 per-
mitted country shall be presumed under para-
graph (1)(H) to be for the purpose of restrict-
ing 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 im-
prove the safety or effectiveness of the 
drug. 
‘‘(4) EFFECT OF SUBSECTION.—
‘‘(A) SALES IN OTHER COUNTRIES.—This 
subsection applies only to the sale or distribu-
tion of a prescription drug in a country if the 
manufacturer of the drug chooses to sell or dis-
tribute 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 sub-
section shall be construed to—
‘‘(i) prevent or restrict a manufac-
turer of a prescription drug from providing 
discounts to an insurer, health plan, phar-
macy benefit manager in the United 
States, or covered entity in the drug dis-
count program under section 340B in re-
turn for inclusion of the drug on a for-
mulary;
‘‘(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 do-
nating a prescription drug, or supplying a 
prescription drug at nominal cost, to a 
charitable or humanitarian organization, 
including the United Nations and affili-
ates, or to a government of a foreign coun-
try; or 
‘‘(ii) apply to such donations or sup-
plying of a prescription drug. 
‘‘(5) ENFORCEMENT.—
‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC-
TICE.—A violation of this subsection shall be 
treated as a violation of a rule defining an un-
fair 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 du-
ties as though all applicable terms and pro-
visions of the Federal Trade Commission 
Act were incorporated into and made a 
part of this section; and 
‘‘(ii) may seek monetary relief three-
fold 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 ap-
propriate jurisdiction for a violation of 
paragraph (1) to—
‘‘(I) enjoin that practice; 
‘‘(II) enforce compliance with 
this subsection;
‘‘(III) obtain damages, restitu-
tion, 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 appro-
priate. 
‘‘(ii) NOTICE.—
‘‘(I) IN GENERAL.—Before filing 
an action under clause (i), the attor-
ney general of the State involved shall 
provide to the Federal Trade Commis-
sion—
‘‘(aa) written notice of that 
action; and 
‘‘(bb) a copy of the com-
plaint for that action. 
‘‘(II) 
EXEMPTION.—Subclause 
(I) shall not apply with respect to the 
filing of an action by an attorney gen-
eral of a State under this paragraph, 
if the attorney general determines 
that it is not feasible to provide the 
notice described in that subclause be-
fore filing of the action. In such case, 
the attorney general of a State shall 
provide notice and a copy of the com-
plaint to the Federal Trade Commis-
sion at the same time as the attorney 
general files the action. 
‘‘(B) INTERVENTION.—
‘‘(i) IN GENERAL.—On receiving no-
tice under subparagraph (A)(ii), the Com-
mission 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 con-
strued to prevent an attorney general of a State 
from exercising the powers conferred on the at-
torney general by the laws of that State to—
‘‘(i) conduct investigations; 
‘‘(ii) administer oaths or affirmations; 
or 
‘‘(iii) compel the attendance of wit-
nesses 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 be-
half 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 vio-
lation 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 dis-
trict court of the United States that meets ap-
plicable 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 defend-
ant—
‘‘(i) is an inhabitant; or 
‘‘(ii) may be found. 
‘‘(G) LIMITATION OF ACTIONS.—Any ac-
tion 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 Commis-
sion, 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 defend-
ant has violated a provision of this subsection, 
damages may be proved and assessed in the ag-
gregate by statistical or sampling methods, by 
the computation of illegal overcharges or by 
such other reasonable system of estimating ag-
gregate 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
RE-
LIEF.—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 re-
lief 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, im-