[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1574 Introduced in House (IH)]
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.
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 2002, 2003, and 2004, such sums as may be necessary to carry out
this Act.
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