
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[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

          (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

                           (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, 
        or
            (B) an individual from providing services in any capacity to 
        a person that has an approved or pending drug product 
        application.

             (2) Persons subject to permissive debarment

        The following persons are subject to debarment under 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) 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 
            subsection (b)(2) 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) or (b)(2)(A) 
            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) 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) 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) of this section 
            if such termination serves the interests of justice and 
            adequately protects the integrity of the drug approval 
            process.

                       (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,
---------------------------------------------------------------------------
    \1\ So in original. Probably should be ``section''.
---------------------------------------------------------------------------
                (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, and clauses (i) and (ii) of subsection 
    (b)(2)(B) 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 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.

(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.)


                            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

    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, 335b of this title.
