PRIA, Government Policy, Made Personal

Summary

The HHS Secretary can fine people who do certain wrongful things connected to an abbreviated drug application. Covered acts include knowingly lying to HHS, bribing or trying to bribe HHS staff, hiding or destroying important government documents, intentionally failing to tell HHS a material fact, obstructing an HHS investigation, using someone who was debarred under section 335a as a contractor or consultant for an approved or pending drug application, or a debarred person who, while banned, provided services to someone with an approved or pending application. The fines can be up to $250,000 for an individual and up to $1,000,000 for any other person for each violation. The Secretary can order a fine after a hearing, or the Attorney General can sue for the penalty instead. When choosing the amount, the Secretary or court looks at things like how serious the act was, ability to pay, and past behavior. No penalty action can cover acts before May 13, 1992, or start more than 6 years after the Secretary knew or should have known the facts, and never more than 10 years after the act. A person can ask the U.S. Court of Appeals (DC or their home circuit) to review the Secretary’s decision within 60 days. The Attorney General can collect the penalty plus interest and may deduct it from money the government owes the person. The Secretary may pay a whistleblower (not a federal employee or someone involved in the wrongdoing) up to $250,000 or half of the collected penalty, whichever is less; that payment decision cannot be reviewed.

Title 21, §335b

Food and Drugs, Source: USLM XML via OLRC

(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 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 procured the destruction, alteration, removal, or secretion of, any material document or other material evidence which was the property of or in the possession of the Department 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 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 335a of this title, or

(7)is an individual debarred under section 335a of this title and, during the period of debarment, 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 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 under subsection (a) shall be assessed by the Secretary on a person by an order made on the record after an opportunity for an agency hearing on disputed issues of material fact and the amount of the penalty. In the course of any investigation or hearing under this subparagraph, 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.

(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 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 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, circumstances, 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 section— (A)

(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 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 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 currently prevailing 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 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 participated 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.

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 307 of act June 25, 1938, was renumbered 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 correction 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.

§335b Civil Penalties