21 U.S. Code § 355f - Extension of exclusivity period for new qualified infectious disease products
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) ofsection 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) ofsection 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.
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; or
(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 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.
Except as provided in paragraph (3), a designation under this subsection shall not be withdrawn for any reason, including modifications to the list of qualifying pathogens under subsection (f)(2)(C).
(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).
In promulgating a regulation implementing this section, the Secretary shall—
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
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;
(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.
In establishing and maintaining the list of pathogens described under this section, the Secretary shall—
(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
Source(June 25, 1938, ch. 675, § 505E, as added Pub. L. 112–144, title VIII, § 801(a),July 9, 2012, 126 Stat. 1077.)
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].”
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