Generic Drug Enforcement Act of 1992
PL 102-282 (H.R.2454), enacted 05/13/1992

PUBLIC LAW 102-282—MAY 13, 1992 
106 STAT. 149 
Public Law 102-282 
102d Congress 
An Act 
To authorize the Secretary of Health and Human Services to impose debarments 
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^
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and to take other action to ensure the integrity of abbreviated drug applications — 
nAKA^— 
under the Federal Food, Drug, and Cosmetic Act, and for other purposes. 
IH.R. ^4o4J 
Be it enacted by the Senate and House of Representatives 
of 
the United States of America in Congress assembled, 
E^f<frc*^iMrSf 
SECTION 1. SHORT TITLE; REFERENCE; FINDINGS; TABLE OF CON- Act of 1992. 
TENTS. 
(a) SHORT TITLE.—This Act may be cited as the "Generic Drug 21 USC 301 
Enforcement Act of 1992". 
note. 
(b) REFERENCE.—^Whenever in this Act cm amendment or repeal 
is expressed in terms of an amendment to, or repeal of, a section 
or other provision, the reference shall be considered to be made 
to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act. 
(c) FINDINGS.—^The Congress finds that— 
21 use 335a 
(1) there is substantial evidence that significant corruption note, 
occurred in the Food and Drug Administration's process of 
approving drugs under abbreviated drug applications, 
(2) there is a need to estabUsh procedures designed to restore 
and to ensure the integrity of the abbreviated drug appUcation 
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. 
(d) TABLE OF CONTENTS.— 
Sec. 1. Short title; reference; findings; table of contents. 
Sec. 2. Debarment and other restrictions. 
"Sec. 306. Debarment, temporary denial of approval, and suspension. 
"(a) Mandatory debarment. 
"(b) Permissive debarment. 
"(c) Debarment period and considerations. 
"(d) Termination of debarment. 
"(e) Publication and list of debarred persons. 
"(f) Temporary denial of approval. 
"(g) Suspension authority. 
"(h) Termination of suspension. 
"(i) Procedure. 
"(j) Judicial review. 
"(k) Certification. 
"(1) Applicability.". 
Sec. 3. Civil penalties. 
"Sec. 307. Civil penalties. 
"(a) In general. 
"(b) Procedure. 
"(c) Judicial review. 
"(d) Recovery of penalties. 
"(e) Informants. . 
Sec. 4. Authority to withdraw approval of abbreviated drug applications. 
"Sec. 308. Authority to withdraw approval of abbreviated drug applications. 
"(a) In general. 
"(b) Procedure. 
106 STAT. 150 
PUBLIC LAW 102-282—MAY 13, 1992 
"(c) Applicability. 
"(d) Judicial review.". 
Sec. 5. Information. 
Sec. 6. Definitions. 
Sec. 7. Effect on other laws. 
SEC. 2. DEBARMENT AND OTHER RESTRICTIONS. 
Sections 306 and 307 (21 U.S.C. 336, 337) are redesignated as 
sections 309 £ind 310, respectively, and the following is inserted 
after section 305: 
"DEBARMENT, TEMPORARY DENIAL OF APPROVAL, AND SUSPENSION 
21 u s e 335a. 
«SEC. 306. (a) MANDATORY DEBARMENT.— 
"(1) CORPORATIONS, PARTNERSHIPS, AND ASSOCIATIONS.—If the 
Secretary finds that a person other than an individual has 
been convicted, after the date of the enactment of this section, 
of a felony under Federed law for conduct relating to the devel-
opment or approval, including the process for development or 
approval, of any abbreviated drug appUcation, the Secretary 
shall debar such person from submitting, or assisting in the 
submission of, £iny such application. 
"(2) INDIVIDUALS.—If the Secretary finds that an individual 
has been convicted of a felony luider Federal law for conduct— 
"(A) relating to the development or approval, including 
the process for development or approval, of any drug prod-
uct, or 
"(B) otherwise relating to the regulation of any drug 
product under this Act, 
the Secretary shall debar such individual from providing serv-
ices 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 Secretar/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) £ui 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 fol-
lowing 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 Taw (if the person 
e 
was convicted before the date of the enactment 
of this section), a misdemeanor imder Federal law, 
or a felony luider 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 (aXD, 
PUBLIC LAW 102-282—MAY 13, 1992 
106 STAT. 151 
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 de-
velopment or approval, including the process for 
development or approval, of any drug product or 
otherwise relating to the regulation of drug prod-
ucts under this Act, or 
"(II) a conspiracy to commit, or aiding or abet-
ting, such criminsd offense or a felony described 
in subsection (a)(2), 
if the Secretary finds that the type of conduct which 
served as the basis for such conviction imdermines 
the process for the regulation of drugs. 
"(ii) Any individual whom the SecretEiry finds has 
been convicted o
f
—
• 
"(I) a felony which is not described in subsection 
(a)(2) or clause (i) of this subparagraph £ind 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 conunit, or aiding or abet-
ting, 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 suffi-
cient to find that there is reason to believe that such 
individual may violate requirements under this Act 
relating to drug products. 
"(iii) Any individual whom the Secretary finds mate-
rially participated in acts that were the basis for a 
conviction for an ofTense described in subsection (a) 
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 individ-
ual has demonstrated a pattern of conduct sufficient 
to find that there is reason to believe that such individ-
ual may violate requirements under this Act 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 individued took actions 
for which a felony conviction was obtained and 
which resulted in the debarment under subsection 
(a)(2), 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. 
106 STAT. 152 
PUBLIC LAW 102-282—MAY 13,1992 
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 ofQcer, 
employee, or agent of the Department or to an 
appropriate law enforcement oflScer, 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 individusd's convic-
tion undermines the process for the regulation of drugs. 
Effective date. 
"(3) STAY OF CERTAIN ORDERS.—An order of the Secretfiuy 
under clause (iii) or (iv) of paragraph (2XB) 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 
appUcation submitted by or with the assistance of a person 
debarred under subsection (aXD or (b)(2XA) during the 
period such person is debarred, 
"(B) shall, during the period of a debarment luider sub-
section (aX2) or (bX2XB), debar an individual firom provid-
ing services in any capacity to a person that has an 
approved or pending drug product appUcation 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 307(a), assess a civil 
penalty in accordance with section 307. 
"(2) DEBARMENT PERIODS.— 
"(A) IN GENERAL.—^The Secretary shall debar a person 
imder subsection (a) or (b) for the following periods: 
"(i) The period of debarment of a person (other than 
an individual) under subsection (aXl) shall not be less 
than 1 year or more than 10 years, but if an act 
leading to a subsequent debarment under subsection 
(a) occurs within 10 years after such person has been 
debarred imder subsection (aXD, the period of debar-
ment shall be permanent. 
"(ii) The debarment of an individual imder subsection 
(aX2) shall be permanent. 
"(iii) The period of debarment of any person under 
subsection (b)(2) 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) or upon execution of 
an agreement with the United States to plead guilty to 
such an offense, the person involved may notify the Sec-
PUBLIC LAW 102-282—MAY 13,1992 
106 STAT. 153 
retary 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) and any period of debarment beyond the minimum specified 
in subparagraph (AXi) of paragraph (2), the Secretary shall 
consider where appUcable— 
"(A) the nature and seriousness of any offense involved, 
"(B) the nature and extent of management participation 
in any offense involved, whether corporate poUcies and 
practices encouraged the offense, including whether inad-
equate institutional controls contributed to the offense, 
"(C) the nature and extent of voluntary steps to mitigate 
the impact on the pubUc of any offense involved, including 
the recall or the discontinuation of the distribution of sus-
pect drugs, full cooperation with any investigations (includ-
ing the extent of disclosure to appropriate authorities of 
all wrongdoing), the relinquishing of profits on drug approv-
als fraudulently obtained, and any other actions taken 
to substantially Umit 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 appUcations and all pending abbre-
viated drug appUcations are free of fraud or material false 
statements, and 
"(F) prior convictions under this Act 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 sub-
section (a) (other than a person permanently debarred) or any 
person that is debarred under subsection (b) may apply to 
the Secretary for termination of the debarment under this 
subsection. Aiiy information submitted to the Secretary under 
this paragraph does not constitute an amendment or supple-
ment to pending or approved abbreviated drug applications. 
"(2) DEADLINE.—^The Secretary shall grant or deny any 
appUcation respecting a debarment which is submitted under 
paragraph (1) within 180 days of the date the appUcation 
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 (aXD or (bX2)(A) is reversed, the 
Secretary shall withdraw the order of debarment. 
"(ii) 
APPLICATION.—^Upon 
appUcation 
submitted 
under paragraph (1), the Secretary shall terminate 
the debarment of a person if the Secretary finds that— 
"(I) changes in ownership, management, or oper-
ations have fully corrected the causes of the offense 
106 STAT. 154 
PUBLIC LAW 102-282—MAY 13, 1992 
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 Adminis-
tration, demonstrate that pending applications and 
the development of drugs being tested before the 
submission of an appHcation are free of fraud or 
material false statements. 
In the case of persons debarred under subsection (a)(1), 
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) or clause (i), (ii), (iii), or (iv) 
of subsection (b)(2)(B) 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) 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 debsured under 
subsection (a)(1) (other than 
a person 
permanently 
debarred under subsection (c)(2)(A)(i)) or any individual 
who is debarred under subsection (a)(2) 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 msiking the appUcation under sub-
paragraph (A) has demonstrated that the felony convic-
tion which was the basis for such person's debarment 
involved the conunission of an offense which was not 
authorized, requested, commanded, performed, or reck-
lessly 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 conmiis-
, 
sion 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 505 or 507, 
"(iii) the person fully cooperated with all investiga-
tions and promptly (Usclosed 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 
PUBLIC LAW 102-282—MAY 13, 1992 
106 STAT. 155 
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 Secretanr may take the action 
described in subparagraph (D) if the Secretary, after an 
informal hearing, finds titiat such individual has provided 
substantial assistance in the investigations or prosecutions 
of offenses which are described in subsection (a) or (b) 
or which relate to any matter under the jurisdiction of 
the Food and Drug Administration. 
"(D) SECRETARIAL ACTION.—^The action referred to in sub-
paragraphs (B) and (C) is— 
"(i) in the case of a person other than an individual— 
"(I) terminating the debarment inmiediately, or 
"(II) Umiting tiie 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 approvsd process. 
"(e) PUBLICATION AND LIST OF DEBARRED PERSONS.—The Sec-
retary shall publish in the Federal Register the name of any person 
debarred under subsection (a) or (b), the effective date of the debar-
ment, and the period of the debarment. The Secretary shall also 
maintain and make available to the public a Ust, updated no less 
often them 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 Secretarjr's own 
initiative or in response to a petition, may, in accordance with 
paragraph (3), refiise by order, for the period prescribed by 
paragraph (2), to approve any abbreviated drug appUcation 
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 Serv-
ices or to any other Federal, State, or local official 
in connection with any abbreviated drug appUcation, 
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 mis-
representations with respect to material facts relating 
to any abbreviated drug appUcation, or the production 
of any drug subject to an abbreviated drug appUcation, 
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 
Federal 
Register, 
publication. 
Public 
information. 
106 STAT. 156 
PUBLIC LAW 102-282—MAY 13, 1992 
., 
"(C) if a significant question has been raised regarding— 
"(i) the integrity of the approv£d process with respect 
to such abbreviated drug apphcation, or 
"(ii) the rehability of data in or concerning such 
person's abbreviated drug apphcation. 
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 syppUcation of a person 
under paragraph (1) shedl be in effect for a period deter-
mined by the Secretary but not to exceed 18 months begin-
ning on the date the Secretary finds that the conditions 
described in subparagraphs (A), (B), and (C) of paragraph 
(1) exist. The Secreteuy 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 per-
son 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 dis-
missed, 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 
i* to refuse approval of an abbreviated drug apphcation. Within 
60 days of the date on which such hearing is held, the Secretary 
shall notify the person given such hearing whether the Sec-
retary'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) in connection 
with 2 or more drugs under abbreviated drug apphca-
tions, or 
"(ii) that a person has engaged in flagrant and 
repeated, material violations of good mgrnufacturing 
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 imdermine the safety 
and efficacy of such drugs, and 
PUBLIC LAW 102-282—MAY 13, 1992 
106 STAT. 157 
"(II) the causes of such violations have not been 
corrected within a reasonable period of time fol-
lowing notice of such violations by the Secretary, 
and 
"(B) such person is under an active investigation by 
a Federsd authority in connection with a civil or criminal 
action involving conduct described in subparagraph (A), 
the Secretary shsill 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 significEUit 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 
Secretar3^s own initiative or in response to a petition, waive 
the suspension under paragraph (1) (involving an action 
described in paragraph (l)(AXi)) 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 Secreteiry. 
"(h) TERMINATION OF SUSPENSION.—^The Secretary shall withdraw 
an order of suspension of the distribution of a drug under subsection 
(g) if the person with respect to whom the order was issued dem-
onstrates in a petition to the Secretary— 
"(1)(A) on the basis of £in audit by the Food and Drug 
Administration or by experts acceptable to the Food £ind Drug 
Administration, or on the basis of other information, that the 
development, approval, manufacturing, and distribution of such 
drug is in substantial compUance with the applicable require-
ments of this Act, 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 suspen-
sion 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) with respect to £iny person 
unless the Secretary has issued an order for such action made 
on the record after opportunity for an agency he£iring 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 subpoe-
nas requiring the attendance and testimony of witnesses and the 
106 STAT. 158 
PUBLIC LAW 102-282—MAY 13, 1992 
production of evidence that relates to the matter under investiga-
tion, 
"(j) JUDICIAL REVIEW.— 
"(1) IN GENERAL.—Except as provided in paragraph (2), any 
person that is the subject of an adverse decision under sub-
section (a), (b), (c), (d), (f), (g), or (h) 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) 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 prod-
uct 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), in connection with such appUcation, and 
"(2) if such application is an abbreviated drug application, 
a list of all convictions, described in subsections (a) and (b) 
which occurred within the previous 5 years, of the appUcant 
and afiiliated persons responsible for the development or sub-
mission of such application. 
"(1) APPLICABILITY.— 
"(1) CONVICTION.—For purposes of this section, a person is 
considered to have been convicted of a crimingd offense— 
"(A) when a judgment of conviction has been entered 
against the person by a Federal or State coiui;, 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, 
•^i;,,,: ,,• 
o r 
, 
"(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), subparagraph (A) of 
subsection (b)(2), and clauses (i) and (ii) of subsection (b)(2XB) 
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). Clauses (iii) and (iv) 
of subsection (b)(2)(B) and subsections (f) and (g) 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). Clause (iv) of subsection (bX2)(B) 
shall not apply to an action which occurred before Jiuie 1, 
1992. Subsection (k) shall not apply to applications submitted 
to the Secretary before June 1, 1992.**. 
PUBLIC LAW 102-282—MAY 13, 1992 
106 STAT. 159 
SEC. 3. CIVIL PENALTIES. 
Chapter III, as amended by section 2, is amended by adding 
after section 306 the following: 
"CIVIL PENALTIES 
"SEC. 307. (a) IN GENERAL.—Any person that the Secretary 21 use 335b. 
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 procxu-ed 
the destruction, alteration, removzd, or secretion of, any mate-
rial document or other material evidence which was the prop-
erty of or in the possession of the Department of Health and 
Human Services for the purpose of interfering with that Dep£ut-
ment's discharge of its responsibiUties in connection with an 
abbreviated drug application, 
"(4) knowingly failed to disclose, to an officer or employee 
of the Department of Health and Hmnan Services, a material 
fact which such person had £in 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 306, or 
"(7) is an individual debarred under section 306 and, during 
the period of debarment, provided services in any capacity 
to a person that had £ui approved or pending drug product 
application, 
shall be liable to the United States for a civil penalty for each 
such violation in an simount 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 imder 
subsection (a) shall be assessed by the Secretary on a 
person by an order made on the record after an opportmiity 
for an agency hearing on disputed issues of material fact 
and the amount of the penalty. In the course of any inves-
tigation or hearing under this subparagraph, the Secretary 
may administer oaths and affirmations, examine witnesses, 
receive evidence, and issue subpoenas requiring the attend-
ance emd 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 
106 STAT. 160 
PUBLIC LAW 102-282—MAY 13, 1992 
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). Such an action 
may be instituted separately from or in connection with 
^ 
any other claim, civil or criminal, initiated by the Attorney 
General imder this Act. 
"(2) AMOUNT.—In determining the amount of a civil penalty 
under paragraph (1), the Secretary or the court shall take 
into account the nature, circiunstances, extent, and gravity 
of the act subject to penalty, the person's abiUty to pay, the 
effect on the person's abiUty 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) 
that occurred before the date of the enactment of this 
Act, 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 imder subsection (bXlXA) 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 currentlv prevailmg rates 
from the date the penalty became final) £Lssessea under subsection 
(b)(1)(A) in an action brought in the name of the United States. 
The amount of such penal^ 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 imder this subsection, tiie 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 psui;icipated in any conduct described 
in subsection (a)) 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.". 
SEC. 4. AUTHORITY TO WITHDRAW APPROVAL OF ABBREVIATED 
DRUG APPLICATIONS. 
Chapter III, as amended by sections 2 and 3, is amended by 
adding after section 307 the following: 
"AUTHORITY TO WITHDRAW APPROVAL OF ABBREVIATED DRUG 
APPUCATIONS 
21 use 335c. 
"SEC. 308. (a) IN GENERAL.—The Secretary— 
PUBLIC LAW 102-282—MAY 13, 1992 
106 STAT. 161 
"(1) shall withdraw approval of an abbreviated drug appUca-
tion if the Secretary finds that the approval was obtsuned, 
expedited, or otherwise faciUtated through bribery, pa3rment 
of an illegal gratuity, or firaud or material false statement, 
and 
"(2) may withdraw approval of an abbreviated drug appUca-
tion if the Secretary finds that the appUcant has repeatedly 
demonstrated a lack of abihty to produce the drug for which 
the apphcation was submitted in accordance with the formula-
tions 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) 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 sub-
section, the Secretary may administer oaths and affirmations, exam-
ine witnesses, receive evidence, and issue subpoenas requiring the 
attendance and testimony of witnesses and the production of evi-
dence that relates to the matter under investigation. 
"(c) APPLICABILITY.—Subsection (a) 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) 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.". 
SEC. 5. INFORMATION. 
Section 505(j) (21 U.S.C. 355(j)) is amended by adding at the 
end the following: 
"(8) The Secretary shall, with respect to each apphcation submit- Records, 
ted under this subsection, msdntain a record of— 
"(A) the name of the apphcant, 
"(B) the name of the drug covered by the apphcation, 
"(C) the name of each person to whom the review of the 
chemistiy of the apphcation W2is assigned and the date of 
such assignment, and 
"(D) the name of each person to whom the bioequivalence 
review for such apphcation was assigned and the date of such 
assignment. 
The information the Secretary is required to maintain under this 
paragraph with respect to an application submitted under this 
subsection shall be made available to the pubhc after the approval 
of such application.". 
SEC. 6. DEFINITIONS. 
Section 201 (21 U.S.C. 321) is amended by adding at the end 
the following: 
"(bb) The term 'abbreviated drug application' means an apphca-
tion submitted under section 505i(j) or 507 for the approval of 
a drug that relies on the approved apphcation of another drug 
with the same active ingredient to estabhsh safety and efficacy, 
and— 
S9-194 O—93 
7 : QL 3 (Pt 1) 
106 STAT. 162 
PUBLIC LAW 102-282—MAY 13, 1992 
"(1) in the case of section 306, includes a supplement to 
^ 
such an application for a different or additional use of the 
drug but does not include a supplement to such an apphcation 
for other than a different or additional use of the drug, and 
"(2) in the case of sections 307 and 308, includes any supple-
ment to such an application, 
"(cc) The term Tcnowingly* or 'knew' means that a person, with 
respect to information— 
"(1) has actual knowledge of the information, or 
"(2) acts in deliberate ignorance or reckless disregsird of the 
truth or falsity of the information, 
"(dd) For purposes of section 306, the term *high managerial 
agent'— 
"(1) meeuis— 
"(A) an officer or (hrector of a corporation or an sissocia-
tion, 
"(B) a partner of a pgirtnership, or 
"(C) any employee or other agent of a corporation, 
association, or partnership, 
having duties such that the conduct of such officer, director, 
partner, employee, or agent may fairly be assumed to represent 
the policy of the corporation, association, or partnership, and 
"(2) includes persons having management responsibility for— 
"(A) submissions to the Food and Drug Administration 
regarding the development or approval of any drug product, 
"(B) production, quality assurance, or quedity control of 
any drug product, or 
"(C) research and development of any drug product, 
"(ee) For purposes of sections 306 and 307, the term 'drug product' 
means a drug subject to regulation imder section 505, 507, 512, 
or 802 of this Act or under section 351 of the Public Health Service 
Act.". 
21 u s e 335a 
SEC. 7. EFFECT ON OTHER LAWS. 
"° • 
No amendment made by this Act shall preclude any other civil, 
criminal, or administrative remedy provided imder 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. 
Approved May 13, 1992. 
LEGISLATIVE HISTORY—H.R. 2454: 
HOUSE REPORTS: No. 102-272 (Comm. on Energy and Commerce). 
CONGRESSIONAL RECORD: 
Vol. 137 (1991): Oct. 28, 31, considered and passed House. 
Vol. 138 (1992): Apr. 10, considered and passed Senate, amended. 
Apr. 28, House concurred in Senate amendments.