---
kind: "section"
citation: "21 U.S.C. § 355–2"
title: "21"
title_heading: "Food and Drugs"
number: "355–2"
heading: "Actions for delays of generic drugs and biosimilar biological products"
release: "119-102"
url: "https://uscodex.org/usc/21/355-2"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §355–2. Actions for delays of generic drugs and biosimilar biological products

- (a) **Definitions—** In this section—
  - (1) the term “commercially reasonable, market-based terms” means—
    - (A) a nondiscriminatory price for the sale of the [covered product](#a-2) at or below, but not greater than, the most recent wholesale acquisition cost for the [drug](/usc/21/321.md?p=g-1), as defined in [section 1395w–3a(c)(6)(B) of title 42](/usc/42/1395w–3a.md?p=c-6-B);
    - (B) a schedule for delivery that results in the transfer of the [covered product](#a-2) to the [eligible product developer](#a-4) consistent with the timing under [subsection (b)(2)(A)(iv)](#b-2-A-iv); and
    - (C) no additional conditions are imposed on the sale of the [covered product](#a-2);
  - (2) the term “covered product”—
    - (A) means—
      - (i) any [drug](/usc/21/321.md?p=g-1) approved under subsection (c) or (j) of [section 355 of this title](/usc/21/355.md) or biological [product](/usc/21/360eee.md?p=13) [licensed](/usc/21/360eee–1.md?p=a-6) under subsection (a) or (k) of [section 262 of title 42](/usc/42/262.md);
      - (ii) any combination of a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) described in [clause (i)](#a-2-A-i); or
      - (iii) when reasonably necessary to support approval of an application under [section 355 of this title](/usc/21/355.md), or [section 262 of title 42](/usc/42/262.md), as applicable, or otherwise meet the requirements for approval under either such section, any [product](/usc/21/360eee.md?p=13), including any [device](#a-3), that is marketed or intended for use with such a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13); and
    - (B) does not include any [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) that appears on the [drug](/usc/21/321.md?p=g-1) shortage list in effect under [section 356e of this title](/usc/21/356e.md), unless—
      - (i) the [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) has been on the [drug](/usc/21/321.md?p=g-1) shortage list in effect under such [section 356e of this title](/usc/21/356e.md) continuously for more than 6 months; or
      - (ii) the [Secretary](#a-8) determines that inclusion of the [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) as a [covered product](#a-2) is likely to contribute to alleviating or preventing a shortage.
  - (3) the term “device” has the meaning given the term in [section 321 of this title](/usc/21/321.md);
  - (4) the term “eligible product developer” means a [person](/usc/21/321.md?p=e) that seeks to develop a [product](/usc/21/360eee.md?p=13) for approval pursuant to an application for approval under subsection (b)(2) or (j) of [section 355 of this title](/usc/21/355.md) or for licensing pursuant to an application under [section 262(k) of title 42](/usc/42/262.md?p=k);
  - (5) the term “license holder” means the holder of an application approved under subsection (c) or (j) of [section 355 of this title](/usc/21/355.md) or the holder of a license under subsection (a) or (k) of [section 262 of title 42](/usc/42/262.md) for a [covered product](#a-2);
  - (6) the term “REMS” means a risk evaluation and mitigation [strategy](/usc/21/1701.md?p=12) under [section 355–1 of this title](/usc/21/355–1.md);
  - (7) the term “REMS with ETASU” means a [REMS](#a-6) that contains elements to assure safe use under [section 355–1(f) of this title](/usc/21/355–1.md?p=f);
  - (8) the term “Secretary” means the Secretary of Health and Human Services;
  - (9) the term “single, shared system of elements to assure safe use” means a single, shared system of elements to assure safe use under [section 355–1(f) of this title](/usc/21/355–1.md?p=f); and
  - (10) the term “sufficient quantities” means an amount of a [covered product](#a-2) that the [eligible product developer](#a-4) determines allows it to—
    - (A) conduct testing to support an application under—
      - (i) subsection (b)(2) or (j) of [section 355 of this title](/usc/21/355.md); or
      - (ii) [section 262(k) of title 42](/usc/42/262.md?p=k); and
    - (B) fulfill any regulatory requirements relating to approval of such an application.
- (b) **Civil action for failure to provide sufficient quantities of a covered product—**
  - (1) **In general—** An [eligible product developer](#a-4) may bring a civil action against the [license holder](#a-5) for a [covered product](#a-2) seeking relief under this subsection in an appropriate district court of the United States alleging that the [license holder](#a-5) has declined to provide [sufficient quantities](#a-10) of the [covered product](#a-2) to the [eligible product developer](#a-4) on [commercially reasonable, market-based terms](#a-1).
  - (2) **Elements—**
    - (A) **In general—** To prevail in a civil action brought under [paragraph (1)](#b-1), an [eligible product developer](#a-4) shall prove, by a preponderance of the evidence—
      - (i) that—
        - (I) the [covered product](#a-2) is not subject to a [REMS with ETASU](#a-7); or
        - (II) if the [covered product](#a-2) is subject to a [REMS with ETASU](#a-7)—
          - (aa) the [eligible product developer](#a-4) has obtained a [covered product](#a-2) authorization from the [Secretary](#a-8) in accordance with [subparagraph (B)](#b-2-B); and
          - (bb) the [eligible product developer](#a-4) has provided a copy of the [covered product](#a-2) authorization to the [license holder](#a-5);
      - (ii) that, as of the date on which the civil action is filed, the [eligible product developer](#a-4) has not obtained [sufficient quantities](#a-10) of the [covered product](#a-2) on [commercially reasonable, market-based terms](#a-1);
      - (iii) that the [eligible product developer](#a-4) has submitted a written request to purchase [sufficient quantities](#a-10) of the [covered product](#a-2) to the [license holder](#a-5), and such request—
        - (I) was sent to a named corporate officer of the [license holder](#a-5);
        - (II) was made by certified or registered mail with return receipt requested;
        - (III) specified an individual as the point of contact for the [license holder](#a-5) to direct communications related to the sale of the [covered product](#a-2) to the [eligible product developer](#a-4) and a means for electronic and written communications with that individual; and
        - (IV) specified an address to which the [covered product](#a-2) was to be shipped upon reaching an agreement to transfer the [covered product](#a-2); and
      - (iv) that the [license holder](#a-5) has not delivered to the [eligible product developer](#a-4) [sufficient quantities](#a-10) of the [covered product](#a-2) on [commercially reasonable, market-based terms](#a-1)—
        - (I) for a [covered product](#a-2) that is not subject to a [REMS with ETASU](#a-7), by the date that is 31 days after the date on which the [license holder](#a-5) received the request for the [covered product](#a-2); and
        - (II) for a [covered product](#a-2) that is subject to a [REMS with ETASU](#a-7), by 31 days after the later of—
          - (aa) the date on which the [license holder](#a-5) received the request for the [covered product](#a-2); or
          - (bb) the date on which the [license holder](#a-5) received a copy of the [covered product](#a-2) authorization issued by the [Secretary](#a-8) in accordance with [subparagraph (B)](#b-2-B).
    - (B) **Authorization for covered product subject to a REMS with ETASU—**
      - (i) **Request—** An [eligible product developer](#a-4) may submit to the [Secretary](#a-8) a written request for the [eligible product developer](#a-4) to be [authorized](/usc/21/360eee–1.md?p=a-6) to obtain [sufficient quantities](#a-10) of an individual [covered product](#a-2) subject to a [REMS with ETASU](#a-7).
      - (ii) **Authorization—** Not later than 120 days after the date on which a request under [clause (i)](#b-2-B-i) is received, the [Secretary](#a-8) shall, by written notice, authorize the [eligible product developer](#a-4) to obtain [sufficient quantities](#a-10) of an individual [covered product](#a-2) subject to a [REMS with ETASU](#a-7) for purposes of—
        - (I) development and testing that does not involve human clinical trials, if the [eligible product developer](#a-4) has agreed to comply with any conditions the [Secretary](#a-8) determines necessary; or
        - (II) development and testing that involves human clinical trials, if the [eligible product developer](#a-4) has—
          - (aa)
            - (AA) submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the [REMS](#a-6) for the [covered product](#a-2); or
            - (BB) otherwise satisfied the [Secretary](#a-8) that such protections will be provided; and
          - (bb) met any other requirements the [Secretary](#a-8) may establish.
      - (iii) **Notice—** A [covered product](#a-2) authorization issued under this subparagraph shall [state](/usc/21/321.md?p=a-1) that the provision of the [covered product](#a-2) by the [license holder](#a-5) under the terms of the authorization will not be a violation of the [REMS](#a-6) for the [covered product](#a-2).
  - (3) **Affirmative defense—** In a civil action brought under [paragraph (1)](#b-1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—
    - (A) that, on the date on which the [eligible product developer](#a-4) requested to purchase [sufficient quantities](#a-10) of the [covered product](#a-2) from the [license holder](#a-5)—
      - (i) neither the [license holder](#a-5) nor any of its agents, [wholesalers](/usc/21/384.md?p=a-5-A), or distributors was engaged in the manufacturing or commercial marketing of the [covered product](#a-2); and
      - (ii) neither the [license holder](#a-5) nor any of its agents, [wholesalers](/usc/21/384.md?p=a-5-A), or distributors otherwise had access to inventory of the [covered product](#a-2) to supply to the [eligible product developer](#a-4) on [commercially reasonable, market-based terms](#a-1);
    - (B) that—
      - (i) the [license holder](#a-5) sells the [covered product](#a-2) through agents, distributors, or [wholesalers](/usc/21/384.md?p=a-5-A);
      - (ii) the [license holder](#a-5) has placed no restrictions, explicit or implicit, on its agents, distributors, or [wholesalers](/usc/21/384.md?p=a-5-A) to sell [covered products](#a-2) to [eligible product developers](#a-4); and
      - (iii) the [covered product](#a-2) can be purchased by the [eligible product developer](#a-4) in [sufficient quantities](#a-10) on [commercially reasonable, market-based terms](#a-1) from the agents, distributors, or [wholesalers](/usc/21/384.md?p=a-5-A) of the [license holder](#a-5); or
    - (C) that the [license holder](#a-5) made an offer to the individual specified pursuant to [paragraph (2)(A)(iii)(III)](#b-2-A-iii-III), by a means of communication (electronic, written, or both) specified pursuant to such paragraph, to sell [sufficient quantities](#a-10) of the [covered product](#a-2) to the [eligible product developer](#a-4) at commercially reasonable market-based terms—
      - (i) for a [covered product](#a-2) that is not subject to a [REMS with ETASU](#a-7), by the date that is 14 days after the date on which the [license holder](#a-5) received the request for the [covered product](#a-2), and the [eligible product developer](#a-4) did not accept such offer by the date that is 7 days after the date on which the [eligible product developer](#a-4) received such offer from the [license holder](#a-5); or
      - (ii) for a [covered product](#a-2) that is subject to a [REMS with ETASU](#a-7), by the date that is 20 days after the date on which the [license holder](#a-5) received the request for the [covered product](#a-2), and the [eligible product developer](#a-4) did not accept such offer by the date that is 10 days after the date on which the [eligible product developer](#a-4) received such offer from the [license holder](#a-5).
  - (4) **Remedies—**
    - (A) **In general—** If an [eligible product developer](#a-4) prevails in a civil action brought under [paragraph (1)](#b-1), the court shall—
      - (i) order the [license holder](#a-5) to provide to the [eligible product developer](#a-4) without delay [sufficient quantities](#a-10) of the [covered product](#a-2) on [commercially reasonable, market-based terms](#a-1);
      - (ii) award to the [eligible product developer](#a-4) reasonable attorney’s fees and costs of the civil action; and
      - (iii) award to the [eligible product developer](#a-4) a monetary amount sufficient to deter the [license holder](#a-5) from failing to provide [eligible product developers](#a-4) with [sufficient quantities](#a-10) of a [covered product](#a-2) on [commercially reasonable, market-based terms](#a-1), if the court finds, by a preponderance of the evidence—
        - (I) that the [license holder](#a-5) delayed providing [sufficient quantities](#a-10) of the [covered product](#a-2) to the [eligible product developer](#a-4) without a legitimate business justification; or
        - (II) that the [license holder](#a-5) failed to comply with an order issued under [clause (i)](#b-4-A-i).
    - (B) **Maximum monetary amount—** A monetary amount awarded under [subparagraph (A)(iii)](#b-4-A-iii) shall not be greater than the revenue that the [license holder](#a-5) earned on the [covered product](#a-2) during the period—
      - (i) beginning on—
        - (I) for a [covered product](#a-2) that is not subject to a [REMS with ETASU](#a-7), the date that is 31 days after the date on which the [license holder](#a-5) received the request; or
        - (II) for a [covered product](#a-2) that is subject to a [REMS with ETASU](#a-7), the date that is 31 days after the later of—
          - (aa) the date on which the [license holder](#a-5) received the request; or
          - (bb) the date on which the [license holder](#a-5) received a copy of the [covered product](#a-2) authorization issued by the [Secretary](#a-8) in accordance with [paragraph (2)(B)](#b-2-B); and
      - (ii) ending on the date on which the [eligible product developer](#a-4) received [sufficient quantities](#a-10) of the [covered product](#a-2).
    - (C) **Avoidance of delay—** The court may issue an order under [subparagraph (A)(i)](#b-4-A-i) before conducting further proceedings that may be necessary to determine whether the [eligible product developer](#a-4) is entitled to an award under clause [(ii)](#b-4-A-ii) or [(iii)](#b-4-A-iii) of subparagraph (A), or the amount of any such award.
- (c) **Limitation of liability—** A [license holder](#a-5) for a [covered product](#a-2) shall not be liable for any claim under Federal, [State](/usc/21/321.md?p=a-1), or local law arising out of the failure of an [eligible product developer](#a-4) to follow adequate safeguards to assure safe use of the [covered product](#a-2) during development or testing activities described in this section, including transportation, handling, use, or disposal of the [covered product](#a-2) by the [eligible product developer](#a-4).
- (d) **Omitted—**
- (e) **Rule of construction—**
  - (1) **Definition—** In this subsection, the term “antitrust laws”—
    - (A) has the meaning given the term in subsection (a) of [section 12 of title 15](/usc/15/12.md); and
    - (B) includes [section 45 of title 15](/usc/15/45.md) to the extent that such section applies to unfair methods of competition.
  - (2) **Antitrust laws—** Nothing in this section shall be construed to limit the operation of any provision of the [antitrust laws](#e-1).
- (f) **Omitted—**
- (g) **Rule of construction—** Nothing in this section, the amendments made by this section, or in [section 355–1 of this title](/usc/21/355–1.md), shall be construed as—
  - (1) prohibiting a [license holder](#a-5) from providing an [eligible product developer](#a-4) access to a [covered product](#a-2) in the absence of an authorization under this section; or
  - (2) in any way negating the applicability of a [REMS with ETASU](#a-7), as otherwise required under such [section 355–1 of this title](/usc/21/355–1.md), with respect to such [covered product](#a-2).

## Source credit

(Pub. L. 116–94, div. N, title I, § 610, Dec. 20, 2019, 133 Stat. 3130.)

## Notes

### Editorial Notes

### Codification

Section was enacted as part of the Further Consolidated Appropriations Act, 2020, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Section is comprised of section 610 of Pub. L. 116–94. Subsecs. (d) and (f) of section 610 of Pub. L. 116–94 amended section 355–1 of this title.