§ 355f. Extension of exclusivity period for new qualified infectious disease products

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title VIII § 801(a) · 126 Stat. 993

   Enacted · 21 U.S.C. § 355f

   June 25, 1938, ch. 675, § 505E, as added Pub. L. 112–144, title VIII, § 801(a), July 9, 2012, 126 Stat. 1077

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 505E, as added Pub. L. 112–144, title VIII, § 801(a), July 9, 2012, 126 Stat. 1077

   Enacted provision · exact public law section
   (a) In General.— Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505D the following: “SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED INFECTIOUS DISEASE PRODUCTS. “(a) Extension.— If the Secretary approves an application pursuant to section 505 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 505, 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 505, or the 7-year period described in section 527, 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 505A with respect to the drug. “(c) Limitations.— Subsection (a) does not apply to the approval of— “(1) a supplement to an application under section 505(b) 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 505 for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or “(3) a product that does not meet the definition of a qualified infectious disease product under subsection (g) based upon its approved uses. “(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 505(b) for such drug. Deadline. Determination. 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 the date of enactment of the Food and Drug Administration Safety and Innovation Act, 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) Notice. issue a notice of proposed rulemaking that includes the proposed regulation; “(B) Time period. provide a period of not less than 60 days for comments on the proposed regulation; and “(C) Publication. 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) Consultation. 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 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).” .

2. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3212(a)(1) · 136 Stat. 4459

   Added · 21 U.S.C. § 355f(c)(4)

   Pub. L. 117–328, § 3212(a)(1), added par. (4)

   Source evidence

   Code amendment note
   Subsec. (c)(4). Pub. L. 117–328, § 3212(a)(1), added par. (4).

   Enacted provision · exact public law section
   (1) in subsection (c)— (A) in paragraph (2), by striking “; or” and inserting “;”; (B) in paragraph (3), by striking the period and inserting “; or”; and (C) by adding at the end the following: “(4) an application pursuant to section 351(a) of the Public Health Service Act.” ;

3. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3212(a)(2) · 136 Stat. 4459

   Inserted · 21 U.S.C. § 355f(d)(1)

   Pub. L. 117–328, § 3212(a)(2), inserted “or section 262(a) of title 42” after “section 355(b) of this title”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   (2) in subsection (d)(1), by inserting “of this Act or section 351(a) of the Public Health Service Act” after “section 505(b)”; and

4. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3212(a)(3) · 136 Stat. 4459

   Amended · 21 U.S.C. § 355f(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—

   Source evidence

   Code amendment note
   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).”

   Enacted provision · exact public law section
   (3) by amending subsection (g) to read as follows: “(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).” .

4 of 4 references resolved to an enrolled provision