§ 335c. — Authority to withdraw approval of abbreviated drug applications.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC335c]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III--PROHIBITED ACTS AND PENALTIES
Sec. 335c. Authority to withdraw approval of abbreviated drug
applications
(a) In general
The Secretary--
(1) shall withdraw approval of an abbreviated drug application
if the Secretary finds that the approval was obtained, expedited, or
otherwise facilitated through bribery, payment of an illegal
gratuity, or fraud or material false statement, and
(2) may withdraw approval of an abbreviated drug application if
the Secretary finds that the applicant has repeatedly demonstrated a
lack of ability to produce the drug for which the application was
submitted in accordance with the formulations or manufacturing
practice set forth in the abbreviated drug application and has
introduced, or attempted to introduce, such adulterated or
misbranded drug into commerce.
(b) Procedure
The Secretary may not take any action under subsection (a) of this
section with respect to any person unless the Secretary has issued an
order for such action made on the record after opportunity for an agency
hearing on disputed issues of material fact. In the course of any
investigation or hearing under this subsection, 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.
(c) Applicability
Subsection (a) of this section shall apply with respect to offenses
or acts regardless of when such offenses or acts occurred.
(d) Judicial review
Any person that is the subject of an adverse decision under
subsection (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.
(June 25, 1938, ch. 675, Sec. 308, as added Pub. L. 102-282, Sec. 4, May
13, 1992, 106 Stat. 160.)
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 section 321 of this title.
