21 USC 355f - Extension of exclusivity period for new qualified infectious disease products

U.S Code last checked for updates: May 05, 2024

§ 355f.

Extension of exclusivity period for new qualified infectious disease products

(a)

Extension

(b)

Relation to pediatric exclusivity

(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

(2)

Limitation

(3)

Revocation of designation

(e)

Regulations

(1)

In general

(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

(4)

Designation prior to regulations

(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

(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

(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.)

cite as: 21 USC 355f