21 U.S.C. § 355f — Extension of exclusivity period for new qualified infectious disease products

(a) Extension If the Secretary approves a drug under section 355 that has been designated a "qualified infectious disease product" under subsection (d), several exclusivity periods for that drug are extended by 5 years: the 4- and 5-year periods described in section 355(c)(3)(E)(ii) and (j)(5)(F)(ii); the 3-year periods described in section 355(c)(3)(E)(iii)-(iv) and (j)(5)(F)(iii)-(iv); or the 7-year period described in section 360cc — whichever applies. (b) Relation to pediatric exclusivity This 5-year extension is added on top of any extension the drug already gets from pediatric exclusivity under section 355a. (c) Limitations The extension in subsection (a) does not apply to the approval of: (1) a supplement to an application under section 355(b) for a qualified infectious disease product that already has an extension in effect or expired; (2) a later application for a change such as a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; (3) a product that no longer meets the definition of a qualified infectious disease product under subsection (g), based on its approved uses; or (4) an application under 42 U.S.C. § 262(a). (d) Designation (1) In general: A manufacturer or sponsor may ask the Secretary to designate a drug as a qualified infectious disease product any time before submitting an application under section 355(b) or 42 U.S.C. § 262(a). The Secretary must decide whether the drug qualifies within 60 days of the request. (2) Limitation: Except as allowed in paragraph (3), a designation cannot be withdrawn for any reason — even if the list of qualifying pathogens changes. (3) Revocation of designation: The Secretary may revoke a designation if the request for it contained an untrue statement of a material fact. (e) Regulations (1) In general: Within 2 years after July 9, 2012, the Secretary must adopt final regulations implementing this section, including building the list of qualifying pathogens described in subsection (f). (2) Procedure: To issue these regulations, the Secretary must: (A) publish a notice of proposed rulemaking with the proposed regulation; (B) allow at least 60 days for public comment; and (C) publish the final regulation at least 30 days before it takes effect. (3) Restrictions: The Secretary may only issue regulations under this section using the process in paragraph (2) — except the Secretary may issue interim guidance for sponsors seeking a designation before those regulations are finished. (4) Designation prior to regulations: Even before the regulations are done, the Secretary must still designate drugs as qualified infectious disease products under subsection (d) if they meet the definition in subsection (g). (f) Qualifying pathogen (1) Definition: A "qualifying pathogen" is a pathogen that the Secretary identifies and lists under paragraph (2) as having the potential to seriously threaten 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 must establish and maintain a public list of qualifying pathogens, and must make public the method used to build it. (B) Considerations: In building and maintaining the list, the Secretary must consider the impact on public health from drug-resistant organisms in humans, how fast such organisms are growing, how much resistance rates are increasing, and the illness and death they cause in humans — and must consult experts in infectious disease and antibiotic resistance, including the CDC, the FDA, medical professionals, and clinical researchers. (C) Review: Every 5 years, or more often if needed, the Secretary must review, update, and publish the list, and revise it by regulation as necessary, following subsection (e). (g) Qualified infectious disease product A "qualified infectious disease product" means a drug (including a biological product) for human use — including an antibacterial or antifungal drug — that (1) acts on bacteria or fungi or on substances they produce, and (2) is intended to treat a serious or life-threatening infection, including one caused by (A) a pathogen resistant to antibacterial or antifungal drugs, including novel or emerging pathogens, or (B) a qualifying pathogen listed by the Secretary under subsection (f).