21 U.S.C. § 335c — Authority to withdraw approval of abbreviated drug applications

submitted 88 years ago by Pub. L. 102-282 to r/title-21-FOOD-AND-DRUGS · 284 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Secretary must withdraw approval of a generic drug application obtained through bribery, fraud, or a false statement. The Secretary may also withdraw approval if a company repeatedly fails to make the drug as approved. Anyone affected by such a decision can appeal to a federal court within 60 days.

(a) The Secretary must withdraw approval of a generic drug application if approval came through bribery, an illegal payment, fraud, or a false statement. The Secretary may also withdraw approval if the applicant repeatedly failed to make the drug as the application described. The applicant must also have put that adulterated or mislabeled drug into commerce. (b) Before acting under subsection (a), the Secretary must issue an order after a hearing on disputed facts, on the record. During any investigation or hearing, the Secretary can administer oaths, question witnesses, gather evidence, and issue subpoenas for witnesses and evidence related to the case. (c) Subsection (a) applies no matter when the underlying conduct happened. (d) Anyone hurt by a decision under subsection (a) can ask a federal Court of Appeals to review it. They must file in the D.C. Circuit or their home circuit within 60 days of being notified of the Secretary's decision. The petition asks the court to modify or set aside that decision.

facts

- Codified at 21 U.S.C. § 335c, titled "Authority to withdraw approval of abbreviated drug applications." - Originates from the Federal Food, Drug, and Cosmetic Act (ch. 675, § 308), enacted June 25, 1938. - Added by Pub. L. 102–282, § 4, dated May 13, 1992 (106 Stat. 160). - Contains 284 words across four subsections (a)–(d). - Source credit reflects a single amendment history (amendmentCount: 1).

the actual law source: uscode.house.gov ↗public domain

(a) In general

The Secretary—

(1)

shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material 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 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 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.

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.

Source credit: (June 25, 1938, ch. 675, § 308, as added Pub. L. 102–282, § 4, May 13, 1992, 106 Stat. 160.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 102-282 · 106 Stat. 160

The record. The source credit indicates that this section originated as part of the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), though the specific provision here—designated § 308—was not part of the original 1938 enactment but was added later by Public Law 102-282, § 4, dated May 13, 1992 (106 Stat. 160). The credit reflects no subsequent amendments beyond this single addition, suggesting the text has remained stable since 1992. Historical context. Public Law 102-282 is generally understood to be the Generic Drug Enforcement Act of 1992, legislation enacted in response to a scandal within the generic drug industry uncovered in the late 1980s. That scandal involved revelations that some generic drug manufacturers and their employees had engaged in bribery of federal officials and submission of fraudulent data to secure approval of abbreviated new drug applications (ANDAs), the streamlined pathway for generic drug approval established under the Hatch-Waxman Act of 1984. The commonly cited purpose of the 1992 Act was to restore integrity to the generic drug approval process by authorizing the Food and Drug Administration to withdraw approvals obtained through corrupt means and to debar individuals convicted of related offenses from participating in the drug approval process. The specific inclusion of the withdrawal-of-approval mechanism reflected in this section is consistent with that broader legislative response, though the record here does not provide section-specific legislative history beyond the source credit itself.

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