son summoned operates or conducts business in 
the United States. 
(B) FEES AND TRAVEL EXPENSES.—Per-
sons summoned under this section shall be paid 
the same fees and mileage for travel in the 
United States that are paid witnesses in the 
courts of the United States. 
(C) NO LIABILITY FOR EXPENSES.—The 
United States shall not be liable for any ex-
pense, other than an expense described in sub-
paragraph (B), incurred in connection with the 
production of books, papers, records, or other 
data under this section. 
(3) SERVICE OF SUMMONS.—Service of a sum-
mons issued under this section may be by registered 
mail or in such other manner calculated to give ac-
tual notice as the officer delegated by the President 
may prescribe by regulation. 
(4) CONTUMACY OR REFUSAL.—
(A) REFERRAL TO ATTORNEY GENERAL.—
In case of contumacy by a person issued a sum-
mons under this subsection or a refusal by such
person to obey such summons, the officer 
issuing the summons shall refer the matter to 
the Attorney General.
(B) JURISDICTION OF COURT.—The Attor-
ney General may invoke the aid of any court of 
the United States within the jurisdiction of 
which—
(i) the investigation which gave rise to 
the summons is being or has been carried 
on; 
(ii) the person summoned is an inhab-
itant; or 
(iii) the person summoned carries on 
business or may be found, 
to compel compliance with the summons. 
(C) COURT ORDER.—The court may issue 
an order requiring the person summoned to ap-
pear before the Secretary or his delegate to 
produce books, papers, records, and other data, 
to give testimony as may be necessary to ex-
plain how such material was compiled and 
maintained, and to pay the costs of the pro-
ceeding.
(D) FAILURE TO COMPLY WITH ORDER.—
Any failure to obey the order of the court may 
be punished by the court as a contempt thereof. 
(E) SERVICE OF PROCESS.—All process in 
any case under this subsection may be served in
any judicial district in which such person may 
be found. 
SEC. 4. ENFORCEMENT. 
(a) INJUNCTIONS AND OTHER RELIEF.—
(1) IN GENERAL.—Whenever it appears to the 
officer authorized by the President to exercise au-
thority under this Act, that any person has engaged, 
is engaged, or is about to engage in any act or prac-
tice that constitutes a violation of any regulation or 
order prescribed or issued pursuant to section 3, the 
officer may request the Attorney General to bring an 
action in an appropriate district court of the United 
States to enjoin such act or practice. 
(2) REMEDIES.—Upon a proper showing in any 
action under paragraph (1), the court—
(A) shall issue a temporary restraining 
order or grant a preliminary or permanent in-
junction without bond; 
(B) may also issue a mandatory injunction 
commanding any person to comply with any 
order or injunction issued or granted under 
subparagraph (A); and 
(C) may order restitution of moneys re-
ceived in violation of any regulation prescribed
or order issued under section 3 or any order 
issued or injunction granted under this section. 
(b) PENALTIES.—
(1) CRIMINAL.—Whoever knowingly violates 
any regulation prescribed or order issued under sec-
tion 3 shall be fined not more than the amount 
equal to 200 percent of the amount of the sale re-
lated to each violation. 
(2) CIVIL.—
(A) IN GENERAL.—Whoever violates any 
regulation prescribed or order issued under sec-
tion 3 shall be liable to the United States for 
a civil penalty of not more than 200 percent of 
the amount by which such person was unjustly 
enriched in connection with such violation. 
(B) CONTINUING VIOLATIONS.—A separate 
violation occurs for each sale of a pharma-
ceutical product in violation of a regulation pre-
scribed or order issued under section 3. 
(C) ASSESSMENT.—
(i) WRITTEN
NOTICE.—Any penalty 
imposed under subparagraph (A) may be 
assessed and collected by the officer au-
thorized by the President to exercise au-
thority under this Act by written notice.
(ii) FINALITY
OF
ASSESSMENT.—If, 
with respect to any assessment under 
clause (i), a hearing is not requested pur-
suant to subparagraph (F) within the pe-
riod of time allowed under such subpara-
graph, the assessment shall constitute a 
final and unappealable order. 
(D) AUTHORITY
TO
MODIFY
OR
REMIT 
PENALTY.—Any officer authorized by the Presi-
dent to exercise authority under this Act may 
compromise, modify, or remit any penalty which 
such officer may assess or had already assessed 
under subparagraph (A). 
(E) 
MITIGATING
FACTORS.—In 
deter-
mining the amount of any penalty imposed 
under subparagraph (A), the officer authorized 
by the President to exercise authority under 
this Act shall take into account the appropriate-
ness of the penalty with respect to—
(i) the size of financial resources and 
good faith of the person charged; 
(ii) the gravity of the violation; 
(iii) the history of previous violations; 
and
(iv) such other matters as justice may 
require. 
(F) HEARING.—The person against whom 
any penalty is assessed under this paragraph 
shall be afforded an agency hearing if such per-
son submits a request for such hearing within 
20 days after the issuance of the notice of as-
sessment. 
(G) COLLECTION.—
(i) REFERRAL.—If any person fails to 
pay an assessment after any penalty as-
sessed under this paragraph has become 
final, the officer who imposed the penalty 
shall recover the amount assessed by ac-
tion in the appropriate United States dis-
trict court. 
(ii) APPROPRIATENESS
OF
PENALTY 
NOT
REVIEWABLE.—In any civil action 
under clause (i), the validity and appro-
priateness of the penalty shall not be sub-
ject to review. 
(H) DISBURSEMENT.—All penalties col-
lected under authority of this paragraph shall 
be deposited into the Treasury.
(I) REGULATIONS.—Any officer authorized 
by the President to exercise authority under 
this Act shall prescribe regulations establishing 
such procedures as may be necessary to carry 
out this paragraph. 
SEC. 5. CIVIL LIABILITY. 
(a) LIABILITY ESTABLISHED.—Any person who vio-
lates any regulation prescribed or order issued under this 
Act with respect to any other person shall be liable to such 
person in an amount equal to the sum of the amounts 
determined under each of the following paragraphs: 
(1) ACTUAL DAMAGES.—The greater of—
(A) the amount of any actual damage sus-
tained by such person as a result of such fail-
ure; or 
(B) any amount paid by the injured person 
to the violator. 
(2) PUNITIVE DAMAGES.—
(A) INDIVIDUAL ACTIONS.—In the case of 
any action by an individual, such additional 
amount as the court may allow. 
(B) CLASS
ACTIONS.—In the case of a 
class action, the sum of—
(i) the aggregate of the amount which 
the court may allow for each named plain-
tiff; and 
(ii) the aggregate of the amount 
which the court may allow for each other 
class member, without regard to any min-
imum individual recovery. 
(3) ATTORNEYS’ FEES.—In the case of any suc-
cessful action to enforce any liability under para-
graph (1) or (2), the costs of the action, together 
with reasonable attorneys’ fees. 
(b) FACTORS TO BE CONSIDERED IN AWARDING PU-
NITIVE DAMAGES.—In determining the amount of any li-
ability of any person under section (a), the court shall con-
sider, among other relevant factors—
(1) the frequency and persistence of noncompli-
ance by the violator; 
(2) the nature of the noncompliance; 
(3) the extent to which such noncompliance was 
intentional; and 
(4) in the case of any class action, the number 
of consumers adversely affected.
SEC. 6. AUTHORIZATION OF APPROPRIATIONS. 
There are authorized to be appropriated to the Presi-
dent for fiscal years 2003, 2004, and 2005, such sums 
as may be necessary to carry out this Act.
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