§ 335b. — Civil penalties.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC335b]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III--PROHIBITED ACTS AND PENALTIES
Sec. 335b. Civil penalties
(a) In general
Any person that the Secretary finds--
(1) knowingly made or caused to be made, to any officer,
employee, or agent of the Department of Health and Human Services, a
false statement or misrepresentation of a material fact in
connection with an abbreviated drug application,
(2) bribed or attempted to bribe or paid or attempted to pay an
illegal gratuity to any officer, employee, or agent of the
Department of Health and Human Services in connection with an
abbreviated drug application,
(3) destroyed, altered, removed, or secreted, or procured the
destruction, alteration, removal, or secretion of, any material
document or other material evidence which was the property of or in
the possession of the Department of Health and Human Services for
the purpose of interfering with that Department's discharge of its
responsibilities in connection with an abbreviated drug application,
(4) knowingly failed to disclose, to an officer or employee of
the Department of Health and Human Services, a material fact which
such person had an obligation to disclose relating to any drug
subject to an abbreviated drug application,
(5) knowingly obstructed an investigation of the Department of
Health and Human Services into any drug subject to an abbreviated
drug application,
(6) is a person that has an approved or pending drug product
application and has knowingly--
(A) employed or retained as a consultant or contractor, or
(B) otherwise used in any capacity the services of,
a person who was debarred under section 335a of this title, or
(7) is an individual debarred under section 335a of this title
and, during the period of debarment, provided services in any
capacity to a person that had an approved or pending drug product
application,
shall be liable to the United States for a civil penalty for each such
violation in an amount not to exceed $250,000 in the case of an
individual and $1,000,000 in the case of any other person.
(b) Procedure
(1) In general
(A) Action by the Secretary
A civil penalty under subsection (a) of this section shall
be assessed by the Secretary on a person by an order made on the
record after an opportunity for an agency hearing on disputed
issues of material fact and the amount of the penalty. In the
course of any investigation or hearing under this subparagraph,
the Secretary may administer oaths and affirmations, examine
witnesses, receive evidence, and issue subpoenas requiring the
attendance and testimony of witnesses and the production of
evidence that relates to the matter under investigation.
(B) Action by the Attorney General
In lieu of a proceeding under subparagraph (A), the Attorney
General may, upon request of the Secretary, institute a civil
action to recover a civil money penalty in the amount and for
any of the acts set forth in subsection (a) of this section.
Such an action may be instituted separately from or in
connection with any other claim, civil or criminal, initiated by
the Attorney General under this chapter.
(2) Amount
In determining the amount of a civil penalty under paragraph
(1), the Secretary or the court shall take into account the nature,
circumstances, extent, and gravity of the act subject to penalty,
the person's ability to pay, the effect on the person's ability to
continue to do business, any history of prior, similar acts, and
such other matters as justice may require.
(3) Limitation on actions
No action may be initiated under this section--
(A) with respect to any act described in subsection (a) of
this section that occurred before May 13, 1992, or
(B) more than 6 years after the date when facts material to
the act are known or reasonably should have been known by the
Secretary but in no event more than 10 years after the date the
act took place.
(c) Judicial review
Any person that is the subject of an adverse decision under
subsection (b)(1)(A) of this section may obtain a review of such
decision by the United States Court of Appeals for the District of
Columbia or for the circuit in which the person resides, by filing in
such court (within 60 days following the date the person is notified of
the Secretary's decision) a petition requesting that the decision be
modified or set aside.
(d) Recovery of penalties
The Attorney General may recover any civil penalty (plus interest at
the currently prevailing rates from the date the penalty became final)
assessed under subsection (b)(1)(A) of this section in an action brought
in the name of the United States. The amount of such penalty may be
deducted, when the penalty has become final, from any sums then or later
owing by the United States to the person against whom the penalty has
been assessed. In an action brought under this subsection, the validity,
amount, and appropriateness of the penalty shall not be subject to
judicial review.
(e) Informants
The Secretary may award to any individual (other than an officer or
employee of the Federal Government or a person who materially
participated in any conduct described in subsection (a) of this section)
who provides information leading to the imposition of a civil penalty
under this section an amount not to exceed--
(1) $250,000, or
(2) one-half of the penalty so imposed and collected,
whichever is less. The decision of the Secretary on such award shall not
be reviewable.
(June 25, 1938, ch. 675, Sec. 307, as added Pub. L. 102-282, Sec. 3, May
13, 1992, 106 Stat. 159; amended Pub. L. 103-80, Sec. 3(g), Aug. 13,
1993, 107 Stat. 776.)
Prior Provisions
A prior section 307 of act June 25, 1938, was renumbered section 310
and is classified to section 337 of this title.
Amendments
1993--Subsec. (b)(3)(A). Pub. L. 103-80 made technical amendment to
reference to May 13, 1992, to reflect correction of corresponding
provision of original act.
Construction
This section not to preclude any other civil, criminal, or
administrative remedy provided under Federal or State law, including any
private right of action against any person for the same action subject
to any action or civil penalty under an amendment made by Pub. L. 102-
282, see section 7 of Pub. L. 102-282, set out as a note under section
335a of this title.
Section Referred to in Other Sections
This section is referred to in sections 321, 335a of this title.
