[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 608 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 608

 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

                            February 5, 2003

  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.

    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 Products Price Equity 
Act''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Modern life enhancing and life sustaining drugs are the 
        products of decades of scientific research and practice.
            (2) The refining and production of products by American 
        pharmaceutical enterprises must be appropriately compensated.
            (3) The pricing of American pharmaceutical products varies 
        greatly from country to country with the corporate owners of 
        such products voluntarily assuming no losses by always selling 
        their products above the cost of production.
            (4) Considering the vital life and death nature of 
        pharmaceutical products, it is appropriate that the United 
        States Government, in harmony with other nations belonging to 
        the World Trade Organization, should engage in the reasonable 
        regulation of the prices of pharmaceutical products.

SEC. 3. REASONABLE LIMITS ON PROFITS OF PHARMACEUTICAL PRODUCTS.

    (a) Presidential Authority.--The President shall issue such orders 
and regulations, and establish such procedures and reporting 
requirements, as the President determines to be appropriate to ensure 
that no pharmaceutical product (as defined by the President in such 
regulation or order) is sold to any consumer in the United States at a 
price that is more than 6 percent above the average retail price at 
which such pharmaceutical product is sold in the 5 most industrialized, 
free-market countries, other than the United States, as determined by 
the President.
    (b) Delegation.--The President may delegate the performance of any 
function under this section to any officer of any Federal department or 
agency who has been appointed by the President, by and with the consent 
of the Senate.
    (c) Confidentiality of Information.--All information reported to or 
otherwise obtained by any person exercising any authority under this 
section which contains or relates to a trade secret or other matter 
referred to in section 1905 of title 18, United States Code, shall be 
considered confidential for purposes of that section, except that such 
information may be disclosed to any other officer or employee of the 
United States involved in carrying out this section solely for the 
purpose of carrying out, and enforcing compliance with, this section.
    (d) Subpoena Power and Production of Documents.--
            (1) In general.--The officer of any agency or department to 
        whom the President has delegated any authority under this 
        section, may--
                    (A) examine any books, papers, records, or other 
                data of any person which is relevant to the enforcement 
                of this section or to any recordkeeping or reporting 
                requirement prescribed for the purpose of carrying out 
                this section; and
                    (B) summon any person, an officer or employee of 
                any person (including a former officer or employee), or 
                any person having possession, custody, or care of the 
                reports and records required to be made or maintained 
                pursuant to this section, to appear at a time and place 
                named in the summons and to produce such books, papers, 
                records, or other data, and to give testimony, under 
                oath, as may be relevant or material to an 
                investigation or procedure under this section.
            (2) Administrative aspects of summons.--
                    (A) Production at designated site.--A summons 
                issued pursuant to this section may require that books, 
                papers, records, or other data stored or maintained at 
                any place be produced at any designated location in any 
                State  or in any territory or other place subject to 
the jurisdiction of the United States not more than 500 miles distant 
from any place where the person summoned operates or conducts business 
in the United States.
                    (B) Fees and travel expenses.--Persons 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 expense, other than an 
                expense described in subparagraph (B), incurred in 
                connection with the production of books, papers, 
                records, or other data under this section.
            (3) Service of summons.--Service of a summons issued under 
        this section may be by registered mail or in such other manner 
        calculated to give actual 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 summons 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 Attorney 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 inhabitant; 
                        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 appear before the 
                Secretary or his delegate to produce books, papers, 
                records, and other data, to give testimony as may be 
                necessary to explain how such material was compiled and 
                maintained, and to pay the costs of the proceeding.
                    (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 authority under this 
        Act, that any person has engaged, is engaged, or is about to 
        engage in any act or practice 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 injunction 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 received 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 section 3 shall be fined not 
        more than the amount equal to 200 percent of the amount of the 
        sale related to each violation.
            (2) Civil.--
                    (A) In general.--Whoever violates any regulation 
                prescribed or order issued under section 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 pharmaceutical product in 
                violation of a regulation prescribed 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 authorized by the 
                        President to exercise authority under this Act 
                        by written notice.
                            (ii) Finality of assessment.--If, with 
                        respect to any assessment under clause (i), a 
                        hearing is not requested pursuant to 
                        subparagraph (F) within the period of time 
                        allowed under such subparagraph, the assessment 
                        shall constitute a final and unappealable 
                        order.
                    (D) Authority to modify or remit penalty.--Any 
                officer authorized by the President 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 determining 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 
                appropriateness 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 person submits a request for 
                such hearing within 20 days after the issuance of the 
                notice of assessment.
                    (G) Collection.--
                            (i) Referral.--If any person fails to pay 
                        an assessment after any penalty assessed under 
                        this paragraph has become final, the officer 
                        who imposed the penalty shall recover the 
                        amount assessed by action in the appropriate 
                        United States district court.
                            (ii) Appropriateness of penalty not 
                        reviewable.--In any civil action under clause 
                        (i), the validity and appropriateness of the 
                        penalty shall not be subject to review.
                    (H) Disbursement.--All penalties collected 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 violates 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 sustained by 
                such person as a result of such failure; 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 plaintiff; and
                            (ii) the aggregate of the amount which the 
                        court may allow for each other class member, 
                        without regard to any minimum individual 
                        recovery.
            (3) Attorneys' fees.--In the case of any successful action 
        to enforce any liability under paragraph (1) or (2), the costs 
        of the action, together with reasonable attorneys' fees.
    (b) Factors To Be Considered in Awarding Punitive Damages.--In 
determining the amount of any liability of any person under section 
(a), the court shall consider, among other relevant factors--
            (1) the frequency and persistence of noncompliance 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 President for fiscal 
years 2003, 2004, and 2005, such sums as may be necessary to carry out 
this Act.
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