21 U.S.C. § 335b — Civil penalties

Page 75 TITLE 21—FOOD AND DRUGS § 335b taining to the regulation of drug products from work- ing for companies that manufacture or distribute such products.’’ § 335b. Civil penalties (a) In general Any person that the Secretary finds— (1) knowingly made or caused to be made, to any officer, employee, or agent of the Depart- ment 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 of- ficer, employee, or agent of the Department of Health and Human Services in connection with an abbreviated drug application, (3) destroyed, altered, removed, or secreted, or procured the destruction, alteration, re- moval, or secretion of, any material document or other material evidence which was the property of or in the possession of the Depart- ment of Health and Human Services for the purpose of interfering with that Department’s discharge of its responsibilities in connection with an abbreviated drug application, (4) knowingly failed to disclose, to an officer or employee of the Department of Health and Human Services, a material fact which such person had an obligation to disclose relating to any drug subject to an abbreviated drug ap- plication, (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 pend- ing drug product application and has know- ingly— (A) employed or retained as a consultant or contractor, or (B) otherwise used in any capacity the services of, a person who was debarred under section 335a of this title, or (7) is an individual debarred under section 335a of this title and, during the period of de- barment, provided services in any capacity to a person that had an approved or pending drug product application, shall be liable to the United States for a civil penalty for each such violation in an amount not to exceed $250,000 in the case of an indi- vidual and $1,000,000 in the case of any other per- son. (b) Procedure (1) In general (A) Action by the Secretary A civil penalty under subsection (a) shall be assessed by the Secretary on a person by an order made on the record after an oppor- tunity for an agency hearing on disputed issues of material fact and the amount of the penalty. In the course of any investiga- tion or hearing under this subparagraph, the Secretary may administer oaths and affir- mations, examine witnesses, receive evi- dence, and issue subpoenas requiring the at- tendance and testimony of witnesses and the production of evidence that relates to the matter under investigation. (B) Action by the Attorney General In lieu of a proceeding under subparagraph (A), the Attorney General may, upon request of the Secretary, institute a civil action to recover a civil money penalty in the amount and for any of the acts set forth in sub- section (a). Such an action may be insti- tuted separately from or in connection with any other claim, civil or criminal, initiated by the Attorney General under this chapter. (2) Amount In determining the amount of a civil penalty under paragraph (1), the Secretary or the court shall take into account the nature, cir- cumstances, extent, and gravity of the act subject to penalty, the person’s ability to pay, the effect on the person’s ability to continue to do business, any history of prior, similar acts, and such other matters as justice may require. (3) Limitation on actions No action may be initiated under this sec- tion— (A) with respect to any act described in subsection (a) that occurred before May 13, 1992, or (B) more than 6 years after the date when facts material to the act are known or rea- sonably should have been known by the Sec- retary but in no event more than 10 years after the date the act took place. (c) Judicial review Any person that is the subject of an adverse decision under subsection (b)(1)(A) 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 de- cision) a petition requesting that the decision be modified or set aside. (d) Recovery of penalties The Attorney General may recover any civil penalty (plus interest at the currently pre- vailing rates from the date the penalty became final) assessed under subsection (b)(1)(A) in an action brought in the name of the United States. The amount of such penalty may be deducted, when the penalty has become final, from any sums then or later owing by the United States to the person against whom the penalty has been assessed. In an action brought under this subsection, the validity, amount, and appro- priateness 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 Fed- eral Government or a person who materially participated in any conduct described in sub- section (a)) who provides information leading to the imposition of a civil penalty under this sec- tion an amount not to exceed— Page 76 TITLE 21—FOOD AND DRUGS § 335c (1) $250,000, or (2) one-half of the penalty so imposed and collected, whichever is less. The decision of the Secretary on such award shall not be reviewable. (June 25, 1938, ch. 675, § 307, as added Pub. L. 102–282, § 3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103–80, § 3(g), Aug. 13, 1993, 107 Stat. 776.) Editorial Notes PRIOR PROVISIONS A prior section 307 of act June 25, 1938, was renum- bered section 310 and is classified to section 337 of this title. AMENDMENTS 1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical amendment to reference to May 13, 1992, to reflect cor- rection of corresponding provision of original act. Statutory Notes and Related Subsidiaries CONSTRUCTION This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title. § 335c. Authority to withdraw approval of abbre- viated drug applications (a) In general The Secretary— (1) shall withdraw approval of an abbre- viated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, pay- ment of an illegal gratuity, or fraud or mate- rial false statement, and (2) may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations or manufacturing prac- tice set forth in the abbreviated drug applica- tion and has introduced, or attempted to in- troduce, 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 ac- tion made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hear- ing under this subsection, the Secretary may ad- minister oaths and affirmations, examine wit- nesses, receive evidence, and issue subpoenas re- quiring the attendance and testimony of wit- nesses and the production of evidence that re- lates to the matter under investigation. (c) Applicability Subsection (a) shall apply with respect to of- fenses 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 re- view 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 deci- sion) a petition requesting that the decision be modified or set aside. (June 25, 1938, ch. 675, § 308, as added Pub. L. 102–282, § 4, May 13, 1992, 106 Stat. 160.) Statutory Notes and Related Subsidiaries CONSTRUCTION This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title. § 336. Report of minor violations Nothing in this chapter shall be construed as requiring the Secretary to report for prosecu- tion, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning. (June 25, 1938, ch. 675, § 309, formerly § 306, 52 Stat. 1045; renumbered § 309, Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150.) Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 337. Proceedings in name of United States; pro- vision as to subpoenas (a) Except as provided in subsection (b), all such proceedings for the enforcement, or to re- strain violations, of this chapter shall be by and in the name of the United States. Subpoenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any proceeding under this section. (b)(1) A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if the food that is the subject of the proceedings is located in the State. (2) No proceeding may be commenced by a State under paragraph (1)— (A) before 30 days after the State has given notice to the Secretary that the State intends to bring such proceeding, (B) before 90 days after the State has given notice to the Secretary of such intent if the Secretary has, within such 30 days, com- menced an informal or formal enforcement ac- tion pertaining to the food which would be the subject of such proceeding, or