21 U.S.C. § 355f (FOOD AND DRUGS)
§ 355f. Extension of exclusivity period for new qualified infectious disease products
(a) Extension
If the Secretary approves an application pursuant to section 355 of this title for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 355 of this title, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 355 of this title, or the 7-year period described in section 360cc of this title, as applicable, shall be extended by 5 years.
(b) Relation to pediatric exclusivity
Any extension under subsection (a) of a period shall be in addition to any extension of the period under section 355a of this title with respect to the drug.
(c) Limitations
Subsection (a) does not apply to the approval of—
(1) a supplement to an application under section 355(b) of this title for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired;
(2) a subsequent application filed with respect to a product approved under section 355 of this title for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength;
(3) a product that does not meet the definition of a qualified infectious disease product under subsection (g) based upon its approved uses; or
(4) an application pursuant to section 262(a) of title 42.
(d) Designation
(1) In general
The manufacturer or sponsor of a drug may request the Secretary to designate a drug as a qualified infectious disease product at any time before the submission of an application under section 355(b) of this title or section 262(a) of title 42 for such drug. The Secretary shall, not later than 60 days after the submission of such a request, determine whether the drug is a qualified infectious disease product.
(2) Limitation
Except as provided in paragraph (3), a designation under this subsection shall not be withdrawn for any reason, including modifications to the list of qualifying pathogens under subsection (f)(2)(C).
(3) Revocation of designation
The Secretary may revoke a designation of a drug as a qualified infectious disease product if the Secretary finds that the request for such designation contained an untrue statement of material fact.
(e) Regulations
(1) In general
Not later than 2 years after July 9, 2012, the Secretary shall adopt final regulations implementing this section, including developing the list of qualifying pathogens described in subsection (f).
(2) Procedure
In promulgating a regulation implementing this section, the Secretary shall—
(A) issue a notice of proposed rulemaking that includes the proposed regulation;
(B) provide a period of not less than 60 days for comments on the proposed regulation; and
(C) publish the final regulation not less than 30 days before the effective date of the regulation.
(3) Restrictions
Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraph (2), except that the Secretary may issue interim guidance for sponsors seeking designation under subsection (d) prior to the promulgation of such regulations.
(4) Designation prior to regulations
The Secretary shall designate drugs as qualified infectious disease products under subsection (d) prior to the promulgation of regulations under this subsection, if such drugs meet the definition of a qualified infectious disease product described in subsection (g).
(f) Qualifying pathogen
(1) Definition
In this section, the term “qualifying pathogen” means a pathogen identified and listed by the Secretary under paragraph (2) that has the potential to pose a serious threat to public health, such as—
(A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;
(B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;
(C) multi-drug resistant tuberculosis; and
(D) Clostridium difficile.
(2) List of qualifying pathogens
(A) In general
The Secretary shall establish and maintain a list of qualifying pathogens, and shall make public the methodology for developing such list.
(B) Considerations
In establishing and maintaining the list of pathogens described under this section, the Secretary shall—
(i) consider—
(I) the impact on the public health due to drug-resistant organisms in humans;
(II) the rate of growth of drug-resistant organisms in humans;
(III) the increase in resistance rates in humans; and
(IV) the morbidity and mortality in humans; and
(ii) consult with experts in infectious diseases and antibiotic resistance, including the Centers for Disease Control and Prevention, the Food and Drug Administration, medical professionals, and the clinical research community.
(C) Review
Every 5 years, or more often as needed, the Secretary shall review, provide modifications to, and publish the list of qualifying pathogens under subparagraph (A) and shall by regulation revise the list as necessary, in accordance with subsection (e).
(g) Qualified infectious disease product
The term “qualified infectious disease product” means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that—
(1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and
(2) is intended to treat a serious or life-threatening infection, including such an infection caused by—
(A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
(B) qualifying pathogens listed by the Secretary under subsection (f).
(June 25, 1938, ch. 675, § 505E, as added Pub. L. 112–144, title VIII, § 801(a), July 9, 2012, 126 Stat. 1077; amended Pub. L. 117–328, div. FF, title III, § 3212(a), Dec. 29, 2022, 136 Stat. 5826.)
heading: Editorial Notes
heading: Amendments
text: 2022—Subsec. (c)(4). Pub. L. 117–328, § 3212(a)(1), added par. (4).
Subsec. (d)(1). Pub. L. 117–328, § 3212(a)(2), inserted “or section 262(a) of title 42” after “section 355(b) of this title”.
Subsec. (g). Pub. L. 117–328, § 3212(a)(3), amended subsec. (g) generally. Prior to amendment, text read as follows: “The term ‘qualified infectious disease product’ means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—
“(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
“(2) qualifying pathogens listed by the Secretary under subsection (f).”
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date
text: Pub. L. 112–144, title VIII, § 801(b), July 9, 2012, 126 Stat. 1079, provided that: “Section 505E of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355f], as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act [July 9, 2012].”