I

107TH CONGRESS

1ST SESSION H. R. 1574

To provide for prices of pharmaceutical products that are fair to the producer

and the consumer, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

APRIL 24, 2001

Mr. OWENS 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 provide for prices of pharmaceutical products that are

fair to the producer and the consumer, and for other

purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Pharmaceutical Prod5 ucts Price Equity Act’’.

6 SEC. 2. FINDINGS.

7 The Congress finds the following:
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1 (1) Modern life enhancing and life sustaining

2 drugs are the products of decades of scientific re3 search and practice.

4 (2) The refining and production of products by

5 American pharmaceutical enterprises must be appro6 priately compensated.

7 (3) The pricing of American pharmaceutical

8 products varies greatly from country to country with

9 the corporate owners of such products voluntarily

10 assuming no losses by always selling their products

11 above the cost of production.

12 (4) Considering the vital life and death nature

13 of pharmaceutical products, it is appropriate that

14 the United States Government, in harmony with

15 other nations belonging to the World Trade Organi16 zation, should engage in the reasonable regulation of

17 the prices of pharmaceutical products.

18 SEC. 3. REASONABLE LIMITS ON PROFITS OF PHARMA19 CEUTICAL PRODUCTS.

20 (a) PRESIDENTIAL AUTHORITY.—The President

21 shall issue such orders and regulations, and establish such

22 procedures and reporting requirements, as the President

23 determines to be appropriate to ensure that no pharma24 ceutical product (as defined by the President in such regu25 lation or order) is sold to any consumer in the United
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1 States at a price that is more than 6 percent above the

2 average retail price at which such pharmaceutical product

3 is sold in the 5 most industrialized, free-market countries,

4 other than the United States, as determined by the Presi5 dent.

6 (b) DELEGATION.—The President may delegate the

7 performance of any function under this section to any offi8 cer of any Federal department or agency who has been

9 appointed by the President, by and with the consent of

10 the Senate.

11 (c) CONFIDENTIALITY OF INFORMATION.—All infor12 mation reported to or otherwise obtained by any person

13 exercising any authority under this section which contains

14 or relates to a trade secret or other matter referred to

15 in section 1905 of title 18, United States Code, shall be

16 considered confidential for purposes of that section, except

17 that such information may be disclosed to any other offi18 cer or employee of the United States involved in carrying

19 out this section solely for the purpose of carrying out, and

20 enforcing compliance with, this section.

21 (d) SUBPOENA POWER AND PRODUCTION OF DOCU22 MENTS.—

23 (1) IN GENERAL.—The officer of any agency or

24 department to whom the President has delegated

25 any authority under this section, may—
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1 (A) examine any books, papers, records, or

2 other data of any person which is relevant to

3 the enforcement of this section or to any rec4 ordkeeping or reporting requirement prescribed

5 for the purpose of carrying out this section; and

6 (B) summon any person, an officer or em7 ployee of any person (including a former officer

8 or employee), or any person having possession,

9 custody, or care of the reports and records re10 quired to be made or maintained pursuant to

11 this section, to appear at a time and place

12 named in the summons and to produce such

13 books, papers, records, or other data, and to

14 give testimony, under oath, as may be relevant

15 or material to an investigation or procedure

16 under this section.

17 (2) ADMINISTRATIVE ASPECTS OF SUMMONS.—

18 (A) PRODUCTION AT DESIGNATED SITE.—

19 A summons issued pursuant to this section may

20 require that books, papers, records, or other

21 data stored or maintained at any place be pro22 duced at any designated location in any State

23 or in any territory or other place subject to the

24 jurisdiction of the United States not more than

25 500 miles distant from any place where the per-
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1 son summoned operates or conducts business in

2 the United States.

3 (B) FEES AND TRAVEL EXPENSES.—Per4 sons summoned under this section shall be paid

5 the same fees and mileage for travel in the

6 United States that are paid witnesses in the

7 courts of the United States.

8 (C) NO LIABILITY FOR EXPENSES.—The

9 United States shall not be liable for any ex10 pense, other than an expense described in sub11 paragraph (B), incurred in connection with the

12 production of books, papers, records, or other

13 data under this section.

14 (3) SERVICE OF SUMMONS.—Service of a sum15 mons issued under this section may be by registered

16 mail or in such other manner calculated to give ac17 tual notice as the officer delegated by the President

18 may prescribe by regulation.

19 (4) CONTUMACY OR REFUSAL.—

20 (A) REFERRAL TO ATTORNEY GENERAL.—

21 In case of contumacy by a person issued a sum22 mons under this subsection or a refusal by such

23 person to obey such summons, the officer

24 issuing the summons shall refer the matter to

25 the Attorney General.
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1 (B) JURISDICTION OF COURT.—The Attor2 ney General may invoke the aid of any court of

3 the United States within the jurisdiction of

4 which—

5 (i) the investigation which gave rise to

6 the summons is being or has been carried

7 on;

8 (ii) the person summoned is an inhab9 itant; or

10 (iii) the person summoned carries on

11 business or may be found,

12 to compel compliance with the summons.

13 (C) COURT ORDER.—The court may issue

14 an order requiring the person summoned to ap15 pear before the Secretary or his delegate to

16 produce books, papers, records, and other data,

17 to give testimony as may be necessary to ex18 plain how such material was compiled and

19 maintained, and to pay the costs of the pro20 ceeding.

21 (D) FAILURE TO COMPLY WITH ORDER.—

22 Any failure to obey the order of the court may

23 be punished by the court as a contempt thereof.

24 (E) SERVICE OF PROCESS.—All process in

25 any case under this subsection may be served in
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1 any judicial district in which such person may

2 be found.

3 SEC. 4. ENFORCEMENT.

4 (a) INJUNCTIONS AND OTHER RELIEF.—

5 (1) IN GENERAL.—Whenever it appears to the

6 officer authorized by the President to exercise au7 thority under this Act, that any person has engaged,

8 is engaged, or is about to engage in any act or prac9 tice that constitutes a violation of any regulation or

10 order prescribed or issued pursuant to section 3, the

11 officer may request the Attorney General to bring an

12 action in an appropriate district court of the United

13 States to enjoin such act or practice.

14 (2) REMEDIES.—Upon a proper showing in any

15 action under paragraph (1), the court—

16 (A) shall issue a temporary restraining

17 order or grant a preliminary or permanent in18 junction without bond;

19 (B) may also issue a mandatory injunction

20 commanding any person to comply with any

21 order or injunction issued or granted under

22 subparagraph (A); and

23 (C) may order restitution of moneys re24 ceived in violation of any regulation prescribed
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1 or order issued under section 3 or any order

2 issued or injunction granted under this section.

3 (b) PENALTIES.—

4 (1) CRIMINAL.—Whoever knowingly violates

5 any regulation prescribed or order issued under sec6 tion 3 shall be fined not more than the amount

7 equal to 200 percent of the amount of the sale re8 lated to each violation.

9 (2) CIVIL.—

10 (A) IN GENERAL.—Whoever violates any

11 regulation prescribed or order issued under sec12 tion 3 shall be liable to the United States for

13 a civil penalty of not more than 200 percent of

14 the amount by which such person was unjustly

15 enriched in connection with such violation.

16 (B) CONTINUING VIOLATIONS.—A separate

17 violation occurs for each sale of a pharma18 ceutical product in violation of a regulation pre19 scribed or order issued under section 3.

20 (C) ASSESSMENT.—

21 (i) WRITTEN NOTICE.—Any penalty

22 imposed under subparagraph (A) may be

23 assessed and collected by the officer au24 thorized by the President to exercise au25 thority under this Act by written notice.
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1 (ii) FINALITY OF ASSESSMENT.—If,

2 with respect to any assessment under

3 clause (i), a hearing is not requested pur4 suant to subparagraph (F) within the pe5 riod of time allowed under such subpara6 graph, the assessment shall constitute a

7 final and unappealable order.

8 (D) AUTHORITY TO MODIFY OR REMIT

9 PENALTY.—Any officer authorized by the Presi10 dent to exercise authority under this Act may

11 compromise, modify, or remit any penalty which

12 such officer may assess or had already assessed

13 under subparagraph (A).

14 (E) MITIGATING FACTORS.—In deter15 mining the amount of any penalty imposed

16 under subparagraph (A), the officer authorized

17 by the President to exercise authority under

18 this Act shall take into account the appropriate19 ness of the penalty with respect to—

20 (i) the size of financial resources and

21 good faith of the person charged;

22 (ii) the gravity of the violation;

23 (iii) the history of previous violations;

24 and
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1 (iv) such other matters as justice may

2 require.

3 (F) HEARING.—The person against whom

4 any penalty is assessed under this paragraph

5 shall be afforded an agency hearing if such per6 son submits a request for such hearing within

7 20 days after the issuance of the notice of as8 sessment.

9 (G) COLLECTION.—

10 (i) REFERRAL.—If any person fails to

11 pay an assessment after any penalty as12 sessed under this paragraph has become

13 final, the officer who imposed the penalty

14 shall recover the amount assessed by ac15 tion in the appropriate United States dis16 trict court.

17 (ii) APPROPRIATENESS OF PENALTY

18 NOT REVIEWABLE.—In any civil action

19 under clause (i), the validity and appro20 priateness of the penalty shall not be sub21 ject to review.

22 (H) DISBURSEMENT.—All penalties col23 lected under authority of this paragraph shall

24 be deposited into the Treasury.
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1 (I) REGULATIONS.—Any officer authorized

2 by the President to exercise authority under

3 this Act shall prescribe regulations establishing

4 such procedures as may be necessary to carry

5 out this paragraph.

6 SEC. 5. CIVIL LIABILITY.

7 (a) LIABILITY ESTABLISHED.—Any person who vio8 lates any regulation prescribed or order issued under this

9 Act with respect to any other person shall be liable to such

10 person in an amount equal to the sum of the amounts

11 determined under each of the following paragraphs:

12 (1) ACTUAL DAMAGES.—The greater of—

13 (A) the amount of any actual damage sus14 tained by such person as a result of such fail15 ure; or

16 (B) any amount paid by the injured person

17 to the violator.

18 (2) PUNITIVE DAMAGES.—

19 (A) INDIVIDUAL ACTIONS.—In the case of

20 any action by an individual, such additional

21 amount as the court may allow.

22 (B) CLASS ACTIONS.—In the case of a

23 class action, the sum of—
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1 (i) the aggregate of the amount which

2 the court may allow for each named plain3 tiff; and

4 (ii) the aggregate of the amount

5 which the court may allow for each other

6 class member, without regard to any min7 imum individual recovery.

8 (3) ATTORNEYS’ FEES.—In the case of any suc9 cessful action to enforce any liability under para10 graph (1) or (2), the costs of the action, together

11 with reasonable attorneys’ fees.

12 (b) FACTORS TO BE CONSIDERED IN AWARDING PU13 NITIVE DAMAGES.—In determining the amount of any li14 ability of any person under section (a), the court shall con15 sider, among other relevant factors—

16 (1) the frequency and persistence of noncompli17 ance by the violator;

18 (2) the nature of the noncompliance;

19 (3) the extent to which such noncompliance was

20 intentional; and

21 (4) in the case of any class action, the number

22 of consumers adversely affected.
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1 SEC. 6. AUTHORIZATION OF APPROPRIATIONS.

2 There are authorized to be appropriated to the Presi3 dent for fiscal years 2002, 2003, and 2004, such sums

4 as may be necessary to carry out this Act.

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