§ 335a. — Debarment, temporary denial of approval, and suspension.
[Laws in effect as of January 7, 2003]
[Document not affected by Public Laws enacted between
January 7, 2003 and December 19, 2003]
[CITE: 21USC335a]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III--PROHIBITED ACTS AND PENALTIES
Sec. 335a. Debarment, temporary denial of approval, and
suspension
(a) Mandatory debarment; certain drug applications
(1) Corporations, partnerships, and associations
If the Secretary finds that a person other than an individual
has been convicted, after May 13, 1992, of a felony under Federal
law for conduct relating to the development or approval, including
the process for development or approval, of any abbreviated drug
application, the Secretary shall debar such person from submitting,
or assisting in the submission of, any such application.
(2) Individuals
If the Secretary finds that an individual has been convicted of
a felony under Federal law for conduct--
(A) relating to the development or approval, including the
process for development or approval, of any drug product, or
(B) otherwise relating to the regulation of any drug product
under this chapter,
the Secretary shall debar such individual from providing services in
any capacity to a person that has an approved or pending drug
product application.
(b) Permissive debarment; certain drug applications; food imports
(1) In general
The Secretary, on the Secretary's own initiative or in response
to a petition, may, in accordance with paragraph (2), debar--
(A) a person other than an individual from submitting or
assisting in the submission of any abbreviated drug application,
(B) an individual from providing services in any capacity to
a person that has an approved or pending drug product
application, or
(C) a person from importing an article of food or offering
such an article for import into the United States.
(2) Persons subject to permissive debarment; certain drug
applications
The following persons are subject to debarment under
subparagraph (A) or (B) of paragraph (1):
(A) Corporations, partnerships, and associations
Any person other than an individual that the Secretary finds
has been convicted--
(i) for conduct that--
(I) relates to the development or approval,
including the process for the development or approval,
of any abbreviated drug application; and
(II) is a felony under Federal law (if the person
was convicted before May 13, 1992), a misdemeanor under
Federal law, or a felony under State law, or
(ii) of a conspiracy to commit, or aiding or abetting, a
criminal offense described in clause (i) or a felony
described in subsection (a)(1) of this section,
if the Secretary finds that the type of conduct which served as
the basis for such conviction undermines the process for the
regulation of drugs.
(B) Individuals
(i) Any individual whom the Secretary finds has been
convicted of--
(I) a misdemeanor under Federal law or a felony under
State law for conduct relating to the development or
approval, including the process for development or approval,
of any drug product or otherwise relating to the regulation
of drug products under this chapter, or
(II) a conspiracy to commit, or aiding or abetting, such
criminal offense or a felony described in subsection (a)(2)
of this section,
if the Secretary finds that the type of conduct which served as
the basis for such conviction undermines the process for the
regulation of drugs.
(ii) Any individual whom the Secretary finds has been
convicted of--
(I) a felony which is not described in subsection (a)(2)
of this section or clause (i) of this subparagraph and which
involves bribery, payment of illegal gratuities, fraud,
perjury, false statement, racketeering, blackmail,
extortion, falsification or destruction of records, or
interference with, obstruction of an investigation into, or
prosecution of, any criminal offense, or
(II) a conspiracy to commit, or aiding or abetting, such
felony,
if the Secretary finds, on the basis of the conviction of such
individual and other information, that such individual has
demonstrated a pattern of conduct sufficient to find that there
is reason to believe that such individual may violate
requirements under this chapter relating to drug products.
(iii) Any individual whom the Secretary finds materially
participated in acts that were the basis for a conviction for an
offense described in subsection (a) of this section or in clause
(i) or (ii) for which a conviction was obtained, if the
Secretary finds, on the basis of such participation and other
information, that such individual has demonstrated a pattern of
conduct sufficient to find that there is reason to believe that
such individual may violate requirements under this chapter
relating to drug products.
(iv) Any high managerial agent whom the Secretary finds--
(I) worked for, or worked as a consultant for, the same
person as another individual during the period in which such
other individual took actions for which a felony conviction
was obtained and which resulted in the debarment under
subsection (a)(2) of this section, or clause (i), of such
other individual,
(II) had actual knowledge of the actions described in
subclause (I) of such other individual, or took action to
avoid such actual knowledge, or failed to take action for
the purpose of avoiding such actual knowledge,
(III) knew that the actions described in subclause (I)
were violative of law, and
(IV) did not report such actions, or did not cause such
actions to be reported, to an officer, employee, or agent of
the Department or to an appropriate law enforcement officer,
or failed to take other appropriate action that would have
ensured that the process for the regulation of drugs was not
undermined, within a reasonable time after such agent first
knew of such actions,
if the Secretary finds that the type of conduct which served as
the basis for such other individual's conviction undermines the
process for the regulation of drugs.
(3) Persons subject to permissive debarment; food
importation
A person is subject to debarment under paragraph (1)(C) if--
(A) the person has been convicted of a felony for conduct
relating to the importation into the United States of any food;
or
(B) the person has engaged in a pattern of importing or
offering for import adulterated food that presents a threat of
serious adverse health consequences or death to humans or
animals.
(4) Stay of certain orders
An order of the Secretary under clause (iii) or (iv) of
paragraph (2)(B) shall not take effect until 30 days after the order
has been issued.
(c) Debarment period and considerations
(1) Effect of debarment
The Secretary--
(A) shall not accept or review (other than in connection
with an audit under this section) any abbreviated drug
application submitted by or with the assistance of a person
debarred under subsection (a)(1) or (b)(2)(A) of this section
during the period such person is debarred,
(B) shall, during the period of a debarment under subsection
(a)(2) or (b)(2)(B) of this section, debar an individual from
providing services in any capacity to a person that has an
approved or pending drug product application and shall not
accept or review (other than in connection with an audit under
this section) an abbreviated drug application from such
individual, and
(C) shall, if the Secretary makes the finding described in
paragraph (6) or (7) of section 335b(a) of this title, assess a
civil penalty in accordance with section 335b of this title.
(2) Debarment periods
(A) In general
The Secretary shall debar a person under subsection (a) or
(b) of this section for the following periods:
(i) The period of debarment of a person (other than an
individual) under subsection (a)(1) of this section shall
not be less than 1 year or more than 10 years, but if an act
leading to a subsequent debarment under subsection (a) of
this section occurs within 10 years after such person has
been debarred under subsection (a)(1) of this section, the
period of debarment shall be permanent.
(ii) The debarment of an individual under subsection
(a)(2) of this section shall be permanent.
(iii) The period of debarment of any person under
paragraph (2) or (3) of subsection (b) of this section shall
not be more than 5 years.
The Secretary may determine whether debarment periods shall run
concurrently or consecutively in the case of a person debarred
for multiple offenses.
(B) Notification
Upon a conviction for an offense described in subsection (a)
or (b) of this section or upon execution of an agreement with
the United States to plead guilty to such an offense, the person
involved may notify the Secretary that the person acquiesces to
debarment and such person's debarment shall commence upon such
notification.
(3) Considerations
In determining the appropriateness and the period of a debarment
of a person under subsection (b) of this section and any period of
debarment beyond the minimum specified in subparagraph (A)(i) of
paragraph (2), the Secretary shall consider where applicable--
(A) the nature and seriousness of any offense involved,
(B) the nature and extent of management participation in any
offense involved, whether corporate policies and practices
encouraged the offense, including whether inadequate
institutional controls contributed to the offense,
(C) the nature and extent of voluntary steps to mitigate the
impact on the public of any offense involved, including the
recall or the discontinuation of the distribution of suspect
drugs, full cooperation with any investigations (including the
extent of disclosure to appropriate authorities of all
wrongdoing), the relinquishing of profits on drug approvals
fraudulently obtained, and any other actions taken to
substantially limit potential or actual adverse effects on the
public health,
(D) whether the extent to which changes in ownership,
management, or operations have corrected the causes of any
offense involved and provide reasonable assurances that the
offense will not occur in the future,
(E) whether the person to be debarred is able to present
adequate evidence that current production of drugs subject to
abbreviated drug applications and all pending abbreviated drug
applications are free of fraud or material false statements, and
(F) prior convictions under this chapter or under other Acts
involving matters within the jurisdiction of the Food and Drug
Administration.
(d) Termination of debarment
(1) Application
Any person that is debarred under subsection (a) of this section
(other than a person permanently debarred) or any person that is
debarred under subsection (b) of this section may apply to the
Secretary for termination of the debarment under this subsection.
Any information submitted to the Secretary under this paragraph does
not constitute an amendment or supplement to pending or approved
abbreviated drug applications.
(2) Deadline
The Secretary shall grant or deny any application respecting a
debarment which is submitted under paragraph (1) within 180 days of
the date the application is submitted.
(3) Action by the Secretary
(A) Corporations
(i) Conviction reversal
If the conviction which served as the basis for the
debarment of a person under subsection (a)(1) of this
section or paragraph (2)(A) or (3) of subsection (b) of this
section is reversed, the Secretary shall withdraw the order
of debarment.
(ii) Application
Upon application submitted under paragraph (1), the
Secretary shall terminate the debarment of a person if the
Secretary finds that--
(I) changes in ownership, management, or operations
have fully corrected the causes of the offense involved
and provide reasonable assurances that the offense will
not occur in the future, and
(II) in applicable cases, sufficient audits,
conducted by the Food and Drug Administration or by
independent experts acceptable to the Food and Drug
Administration, demonstrate that pending applications
and the development of drugs being tested before the
submission of an application are free of fraud or
material false statements.
In the case of persons debarred under subsection (a)(1) of
this section, such termination shall take effect no earlier
than the expiration of one year from the date of the
debarment.
(B) Individuals
(i) Conviction reversal
If the conviction which served as the basis for the
debarment of an individual under subsection (a)(2) of this
section or clause (i), (ii), (iii), or (iv) of subsection
(b)(2)(B) or subsection (b)(3) of this section is reversed,
the Secretary shall withdraw the order of debarment.
(ii) Application
Upon application submitted under paragraph (1), the
Secretary shall terminate the debarment of an individual who
has been debarred under subsection (b)(2)(B) or subsection
(b)(3) of this section if such termination serves the
interests of justice and adequately protects the integrity
of the drug approval process or the food importation
process, as the case may be.
(4) Special termination
(A) Application
Any person that is debarred under subsection (a)(1) of this
section (other than a person permanently debarred under
subsection (c)(2)(A)(i) of this section) or any individual who
is debarred under subsection (a)(2) of this section may apply to
the Secretary for special termination of debarment under this
subsection. Any information submitted to the Secretary under
this subparagraph does not constitute an amendment or supplement
to pending or approved abbreviated drug applications.
(B) Corporations
Upon an application submitted under subparagraph (A), the
Secretary may take the action described in subparagraph (D) if
the Secretary, after an informal hearing, finds that--
(i) the person making the application under subparagraph
(A) has demonstrated that the felony conviction which was
the basis for such person's debarment involved the
commission of an offense which was not authorized,
requested, commanded, performed, or recklessly tolerated by
the board of directors or by a high managerial agent acting
on behalf of the person within the scope of the board's or
agent's office or employment,
(ii) all individuals who were involved in the commission
of the offense or who knew or should have known of the
offense have been removed from employment involving the
development or approval of any drug subject to sections \1\
355 of this title,
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\1\ So in original. Probably should be ``section''.
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(iii) the person fully cooperated with all
investigations and promptly disclosed all wrongdoing to the
appropriate authorities, and
(iv) the person acted to mitigate any impact on the
public of any offense involved, including the recall, or the
discontinuation of the distribution, of any drug with
respect to which the Secretary requested a recall or
discontinuation of distribution due to concerns about the
safety or efficacy of the drug.
(C) Individuals
Upon an application submitted under subparagraph (A), the
Secretary may take the action described in subparagraph (D) if
the Secretary, after an informal hearing, finds that such
individual has provided substantial assistance in the
investigations or prosecutions of offenses which are described
in subsection (a) or (b) of this section or which relate to any
matter under the jurisdiction of the Food and Drug
Administration.
(D) Secretarial action
The action referred to in subparagraphs (B) and (C) is--
(i) in the case of a person other than an individual--
(I) terminating the debarment immediately, or
(II) limiting the period of debarment to less than
one year, and
(ii) in the case of an individual, limiting the period
of debarment to less than permanent but to no less than 1
year,
whichever best serves the interest of justice and protects the
integrity of the drug approval process.
(e) Publication and list of debarred persons
The Secretary shall publish in the Federal Register the name of any
person debarred under subsection (a) or (b) of this section, the
effective date of the debarment, and the period of the debarment. The
Secretary shall also maintain and make available to the public a list,
updated no less often than quarterly, of such persons, of the effective
dates and minimum periods of such debarments, and of the termination of
debarments.
(f) Temporary denial of approval
(1) In general
The Secretary, on the Secretary's own initiative or in response
to a petition, may, in accordance with paragraph (3), refuse by
order, for the period prescribed by paragraph (2), to approve any
abbreviated drug application submitted by any person--
(A) if such person is under an active Federal criminal
investigation in connection with an action described in
subparagraph (B),
(B) if the Secretary finds that such person--
(i) has bribed or attempted to bribe, has paid or
attempted to pay an illegal gratuity, or has induced or
attempted to induce another person to bribe or pay an
illegal gratuity to any officer, employee, or agent of the
Department of Health and Human Services or to any other
Federal, State, or local official in connection with any
abbreviated drug application, or has conspired to commit, or
aided or abetted, such actions, or
(ii) has knowingly made or caused to be made a pattern
or practice of false statements or misrepresentations with
respect to material facts relating to any abbreviated drug
application, or the production of any drug subject to an
abbreviated drug application, to any officer, employee, or
agent of the Department of Health and Human Services, or has
conspired to commit, or aided or abetted, such actions, and
(C) if a significant question has been raised regarding--
(i) the integrity of the approval process with respect
to such abbreviated drug application, or
(ii) the reliability of data in or concerning such
person's abbreviated drug application.
Such an order may be modified or terminated at any time.
(2) Applicable period
(A) In general
Except as provided in subparagraph (B), a denial of approval
of an application of a person under paragraph (1) shall be in
effect for a period determined by the Secretary but not to
exceed 18 months beginning on the date the Secretary finds that
the conditions described in subparagraphs (A), (B), and (C) of
paragraph (1) exist. The Secretary shall terminate such denial--
(i) if the investigation with respect to which the
finding was made does not result in a criminal charge
against such person, if criminal charges have been brought
and the charges have been dismissed, or if a judgment of
acquittal has been entered, or
(ii) if the Secretary determines that such finding was
in error.
(B) Extension
If, at the end of the period described in subparagraph (A),
the Secretary determines that a person has been criminally
charged for an action described in subparagraph (B) of paragraph
(1), the Secretary may extend the period of denial of approval
of an application for a period not to exceed 18 months. The
Secretary shall terminate such extension if the charges have
been dismissed, if a judgment of acquittal has been entered, or
if the Secretary determines that the finding described in
subparagraph (A) was in error.
(3) Informal hearing
Within 10 days of the date an order is issued under paragraph
(1), the Secretary shall provide such person with an opportunity for
an informal hearing, to be held within such 10 days, on the decision
of the Secretary to refuse approval of an abbreviated drug
application. Within 60 days of the date on which such hearing is
held, the Secretary shall notify the person given such hearing
whether the Secretary's refusal of approval will be continued,
terminated, or otherwise modified. Such notification shall be final
agency action.
(g) Suspension authority
(1) In general
If--
(A) the Secretary finds--
(i) that a person has engaged in conduct described in
subparagraph (B) of subsection (f)(1) of this section in
connection with 2 or more drugs under abbreviated drug
applications, or
(ii) that a person has engaged in flagrant and repeated,
material violations of good manufacturing practice or good
laboratory practice in connection with the development,
manufacturing, or distribution of one or more drugs approved
under an abbreviated drug application during a 2-year
period, and--
(I) such violations may undermine the safety and
efficacy of such drugs, and
(II) the causes of such violations have not been
corrected within a reasonable period of time following
notice of such violations by the Secretary, and
(B) such person is under an active investigation by a
Federal authority in connection with a civil or criminal action
involving conduct described in subparagraph (A),
the Secretary shall issue an order suspending the distribution of
all drugs the development or approval of which was related to such
conduct described in subparagraph (A) or suspending the distribution
of all drugs approved under abbreviated drug applications of such
person if the Secretary finds that such conduct may have affected
the development or approval of a significant number of drugs which
the Secretary is unable to identify. The Secretary shall exclude a
drug from such order if the Secretary determines that such conduct
was not likely to have influenced the safety or efficacy of such
drug.
(2) Public health waiver
The Secretary shall, on the Secretary's own initiative or in
response to a petition, waive the suspension under paragraph (1)
(involving an action described in paragraph (1)(A)(i)) with respect
to any drug if the Secretary finds that such waiver is necessary to
protect the public health because sufficient quantities of the drug
would not otherwise be available. The Secretary shall act on any
petition seeking action under this paragraph within 180 days of the
date the petition is submitted to the Secretary.
(h) Termination of suspension
The Secretary shall withdraw an order of suspension of the
distribution of a drug under subsection (g) of this section if the
person with respect to whom the order was issued demonstrates in a
petition to the Secretary--
(1)(A) on the basis of an audit by the Food and Drug
Administration or by experts acceptable to the Food and Drug
Administration, or on the basis of other information, that the
development, approval, manufacturing, and distribution of such drug
is in substantial compliance with the applicable requirements of
this chapter, and
(B) changes in ownership, management, or operations--
(i) fully remedy the patterns or practices with respect to
which the order was issued, and
(ii) provide reasonable assurances that such actions will
not occur in the future, or
(2) the initial determination was in error.
The Secretary shall act on a submission of a petition under this
subsection within 180 days of the date of its submission and the
Secretary may consider the petition concurrently with the suspension
proceeding. Any information submitted to the Secretary under this
subsection does not constitute an amendment or supplement to a pending
or approved abbreviated drug application.
(i) Procedure
The Secretary may not take any action under subsection (a), (b),
(c), (d)(3), (g), or (h) 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.
(j) Judicial review
(1) In general
Except as provided in paragraph (2), any person that is the
subject of an adverse decision under subsection (a), (b), (c), (d),
(f), (g), or (h) 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.
(2) Exception
Any person that is the subject of an adverse decision under
clause (iii) or (iv) of subsection (b)(2)(B) of this section may
obtain a review of such decision by the United States District Court
for the District of Columbia or a district court of the United
States for the district in which the person resides, by filing in
such court (within 30 days following the date the person is notified
of the Secretary's decision) a complaint requesting that the
decision be modified or set aside. In such an action, the court
shall determine the matter de novo.
(k) Certification
Any application for approval of a drug product shall include--
(1) a certification that the applicant did not and will not use
in any capacity the services of any person debarred under subsection
(a) or (b) of this section, in connection with such application, and
(2) if such application is an abbreviated drug application, a
list of all convictions, described in subsections (a) and (b) of
this section which occurred within the previous 5 years, of the
applicant and affiliated persons responsible for the development or
submission of such application.
(l) Applicability
(1) Conviction
For purposes of this section, a person is considered to have
been convicted of a criminal offense--
(A) when a judgment of conviction has been entered against
the person by a Federal or State court, regardless of whether
there is an appeal pending,
(B) when a plea of guilty or nolo contendere by the person
has been accepted by a Federal or State court, or
(C) when the person has entered into participation in a
first offender, deferred adjudication, or other similar
arrangement or program where judgment of conviction has been
withheld.
(2) Effective dates
Subsection (a) of this section, subparagraph (A) of subsection
(b)(2) of this section, clauses (i) and (ii) of subsection (b)(2)(B)
of this section, and subsection (b)(3)(A) of this section shall not
apply to a conviction which occurred more than 5 years before the
initiation of an agency action proposed to be taken under subsection
(a) or (b) of this section. Clauses (iii) and (iv) of subsection
(b)(2)(B) of this section, subsection (b)(3)(B) of this section, and
subsections (f) and (g) of this section shall not apply to an act or
action which occurred more than 5 years before the initiation of an
agency action proposed to be taken under subsection (b), (f), or (g)
of this section. Clause (iv) of subsection (b)(2)(B) of this section
shall not apply to an action which occurred before June 1, 1992.
Subsection (k) of this section shall not apply to applications
submitted to the Secretary before June 1, 1992.
(m) Devices; mandatory debarment regarding third-party inspections and
reviews
(1) In general
If the Secretary finds that a person has been convicted of a
felony under section 331(gg) of this title, the Secretary shall
debar such person from being accredited under section 360m(b) or
374(g)(2) of this title and from carrying out activities under an
agreement described in section 383(b) of this title.
(2) Debarment period
The Secretary shall debar a person under paragraph (1) for the
following periods:
(A) The period of debarment of a person (other than an
individual) shall not be less than 1 year or more than 10 years,
but if an act leading to a subsequent debarment under such
paragraph occurs within 10 years after such person has been
debarred under such paragraph, the period of debarment shall be
permanent.
(B) The debarment of an individual shall be permanent.
(3) Termination of debarment; judicial review; other matters
Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this
section apply with respect to a person (other than an individual) or
an individual who is debarred under paragraph (1) to the same extent
and in the same manner as such subsections apply with respect to a
person who is debarred under subsection (a)(1) of this section, or
an individual who is debarred under subsection (a)(2) of this
section, respectively.
(June 25, 1938, ch. 675, Sec. 306, as added Pub. L. 102-282, Sec. 2, May
13, 1992, 106 Stat. 150; amended Pub. L. 105-115, title I,
Sec. 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107-188, title
III, Sec. 304(a)-(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107-
250, title II, Sec. 203, Oct. 26, 2002, 116 Stat. 1610.)
Prior Provisions
A prior section 306 of act June 25, 1938, was renumbered section 309
and is classified to section 336 of this title.
Amendments
2002--Subsec. (a). Pub. L. 107-188, Sec. 304(b)(1), substituted
``Mandatory debarment; certain drug applications'' for ``Mandatory
debarment'' in heading.
Subsec. (b). Pub. L. 107-188, Sec. 304(b)(2)(A), substituted
``Permissive debarment; certain drug applications; food imports'' for
``Permissive debarment'' in heading.
Subsec. (b)(1)(C). Pub. L. 107-188, Sec. 304(a)(1), added subpar.
(C).
Subsec. (b)(2). Pub. L. 107-188, Sec. 304(b)(2)(B), substituted
``permissive debarment; certain drug applications'' for ``permissive
debarment'' in heading.
Pub. L. 107-188, Sec. 304(a)(2)(A), inserted ``subparagraph (A) or
(B) of'' before ``paragraph (1)'' in introductory provisions.
Subsec. (b)(3), (4). Pub. L. 107-188, Sec. 304(a)(2)(B), (C), added
par. (3) and redesignated former par. (3) as (4).
Subsec. (c)(2)(A)(iii). Pub. L. 107-188, Sec. 304(b)(3), substituted
``paragraph (2) or (3) of subsection (b)'' for ``subsection (b)(2)''.
Subsec. (d)(3)(A)(i). Pub. L. 107-188, Sec. 304(b)(4)(A),
substituted ``subsection (a)(1) of this section or paragraph (2)(A) or
(3) of subsection (b)'' for ``subsection (a)(1) or (b)(2)(A)''.
Subsec. (d)(3)(A)(ii)(II). Pub. L. 107-188, Sec. 304(b)(4)(B),
inserted ``in applicable cases,'' before ``sufficient audits''.
Subsec. (d)(3)(B)(i). Pub. L. 107-188, Sec. 304(b)(4)(C), inserted
``or subsection (b)(3)'' after ``subsection (b)(2)(B)''.
Subsec. (d)(3)(B)(ii). Pub. L. 107-188, Sec. 304(b)(4)(C), (D),
inserted ``or subsection (b)(3)'' after ``subsection (b)(2)(B)'' and
``or the food importation process, as the case may be'' before period.
Subsec. (l)(2). Pub. L. 107-188, Sec. 304(c), in first sentence
struck out ``and'' after ``subsection (b)(2) of this section,'' and
inserted ``, and subsection (b)(3)(A) of this section'' after
``subsection (b)(2)(B) of this section'' and in second sentence inserted
``, subsection (b)(3)(B) of this section,'' after ``subsection (b)(2)(B)
of this section''.
Subsec. (m). Pub. L. 107-250 added subsec. (m).
1997--Subsec. (d)(4)(B)(ii). Pub. L. 105-115 struck out ``or 357''
after ``355''.
Construction
Section 7 of Pub. L. 102-282 provided that: ``No amendment made by
this Act [enacting this section and sections 335b and 335c of this title
and amending sections 321, 336, 337, and 355 of this title] shall
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 this Act.''
Congressional Findings
Section 1(c) of Pub. L. 102-282 provided that: ``The Congress finds
that--
``(1) there is substantial evidence that significant corruption
occurred in the Food and Drug Administration's process of approving
drugs under abbreviated drug applications,
``(2) there is a need to establish procedures designed to
restore and to ensure the integrity of the abbreviated drug
application approval process and to protect the public health, and
``(3) there is a need to establish procedures to bar individuals
who have been convicted of crimes pertaining to the regulation of
drug products from working for companies that manufacture or
distribute such products.''
Section Referred to in Other Sections
This section is referred to in sections 321, 331, 335b, 381 of this
title.
