turer has discriminated under subparagraph 
(A), (B), (C), (D), or (M) of paragraph (1) that 
the higher price charged for a prescription drug 
sold to a person, the denial, restriction, or delay 
of supplies of a prescription drug to a person, 
the refusal to do business with a person, or 
other discriminatory activity against a person, 
is not based, in whole or in part, on— 
‘‘(i) the person exporting or importing 
a qualifying drug into the United States 
under this section; or 
‘‘(ii) the person distributing, selling, 
or using a qualifying drug imported into 
the United States under this section. 
‘‘(B) DRUG DIFFERENCES.—It shall be an 
affirmative defense to a charge that a manufac-
turer has caused there to be a difference de-
scribed in subparagraph (G) of paragraph (1) 
that— 
‘‘(i) the difference was required by the 
country in which the drug is distributed; 
‘‘(ii) the Secretary has determined 
that the difference was necessary to im-
prove the safety or effectiveness of the 
drug;
‘‘(iii) the person manufacturing the 
drug for distribution in the United States 
has given notice to the Secretary under 
subsection (g)(2)(B)(i) that the drug for 
distribution in the United States is not dif-
ferent from a drug for distribution in per-
mitted countries whose combined popu-
lation represents at least 50 percent of the 
total population of all permitted countries; 
or 
‘‘(iv) the difference was not caused, in 
whole or in part, for the purpose of re-
stricting importation of the drug into the 
United States under this section. 
‘‘(3) 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 of the 
Public Health Service Act (42 U.S.C. 
256b) 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 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. 
‘‘(4) 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 (15 U.S.C. 57a(a)(1)(B)). 
‘‘(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 (15 U.S.C. 41 et seq.) were incor-
porated into and made a part of this sec-
tion; and 
‘‘(ii) may seek monetary relief three-
fold the damages sustained, in addition to 
any other remedy available to the Federal
Trade Commission under the Federal 
Trade Commission Act (15 U.S.C. 41 et 
seq.). 
‘‘(5) ACTIONS BY STATES.— 
‘‘(A) IN GENERAL.— 
‘‘(i) CIVIL ACTIONS.—In any case in 
which the attorney general of a State has 
reason to believe that an interest of the 
residents of that State have been adversely 
affected by any manufacturer that violates 
paragraph (1), 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 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