21 U.S.C. § 355f — Extension of exclusivity period for new

Page 260 TITLE 21—FOOD AND DRUGS § 355d reports, including recommendations therein, regarding the topics addressed in the reports under this section, including with respect to— ‘‘(A) improving public access to information from pediatric studies conducted under such sections 355a and 355c of this title; and ‘‘(B) improving the timeliness of pediatric studies and pediatric study planning under such sections 355a and 355c of this title.’’ Statutory Notes and Related Subsidiaries RULE OF CONSTRUCTION Nothing in amendment by Pub. L. 115–52 to limit the authority of the Secretary of Health and Human Serv- ices to issue written requests under section 355a of this title or section 262(m) of Title 42, The Public Health and Welfare, or to negotiate or implement amendments to such requests proposed by applicants, see section 504(e) of Pub. L. 115–52, set out as a note under section 355c of this title. DEFINITION OF ‘‘SECRETARY’’ The term ‘‘Secretary’’ as used in this section means the Secretary of Health and Human Services, see sec- tion 503 of Pub. L. 112–144, set out as a note under sec- tion 355a of this title. § 355d. Internal committee for review of pedi- atric plans, assessments, deferrals, deferral extensions, and waivers The Secretary shall establish an internal com- mittee within the Food and Drug Administra- tion to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such in- ternal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharma- cology, statistics, chemistry, legal issues, pedi- atric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and ado- lescent psychiatry or pediatric rare diseases, and other individuals designated by the Sec- retary. (June 25, 1938, ch. 675, § 505C, as added Pub. L. 110–85, title IV, § 403, Sept. 27, 2007, 121 Stat. 875; amended Pub. L. 112–144, title V, § 509(c), July 9, 2012, 126 Stat. 1049; Pub. L. 115–52, title V, § 505(f), Aug. 18, 2017, 131 Stat. 1047.) Editorial Notes AMENDMENTS 2017—Pub. L. 115–52 inserted ‘‘or pediatric rare dis- eases’’ after ‘‘psychiatry’’. 2012—Pub. L. 112–144 inserted ‘‘deferral extensions,’’ after ‘‘deferrals,’’ in section catchline and ‘‘neonatology,’’ after ‘‘pediatric ethics,’’ in text. § 355e. Pharmaceutical security (a) In general The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, sub- standard, adulterated, misbranded, or expired drugs. (b) Standards development (1) In general The Secretary shall, in consultation with the agencies specified in paragraph (4), manu- facturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and de- velop standards for the identification, valida- tion, authentication, and tracking and tracing of prescription drugs. (2) Standardized numeral identifier Not later than 30 months after September 27, 2007, the Secretary shall develop a standard- ized numerical identifier (which, to the extent practicable, shall be harmonized with inter- national consensus standards for such an iden- tifier) to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the iden- tification, validation, authentication, and tracking and tracing of the prescription drug. (3) Promising technologies The standards developed under this sub- section shall address promising technologies, which may include— (A) radio frequency identification tech- nology; (B) nanotechnology; (C) encryption technologies; and (D) other track-and-trace or authentica- tion technologies. (4) Interagency collaboration In carrying out this subsection, the Sec- retary shall consult with Federal health and security agencies, including— (A) the Department of Justice; (B) the Department of Homeland Security; (C) the Department of Commerce; and (D) other appropriate Federal and State agencies. (c) Inspection and enforcement (1) In general The Secretary shall expand and enhance the resources and facilities of agency components of the Food and Drug Administration involved with regulatory and criminal enforcement of this chapter to secure the drug supply chain against counterfeit, diverted, subpotent, sub- standard, adulterated, misbranded, or expired drugs including biological products and active pharmaceutical ingredients from domestic and foreign sources. (2) Activities The Secretary shall undertake enhanced and joint enforcement activities with other Fed- eral and State agencies, and establish regional capacities for the validation of prescription drugs and the inspection of the prescription drug supply chain. (d) Definition In this section, the term ‘‘prescription drug’’ means a drug subject to section 353(b)(1) of this title. (June 25, 1938, ch. 675, § 505D, as added Pub. L. 110–85, title IX, § 913, Sept. 27, 2007, 121 Stat. 952.) § 355f. Extension of exclusivity period for new qualified infectious disease products (a) Extension If the Secretary approves an application pur- suant to section 355 of this title for a drug that Page 261 TITLE 21—FOOD AND DRUGS § 355f has been designated as a qualified infectious dis- ease 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 pe- riod 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 sec- tion 355(b) of this title for any qualified infec- tious disease product for which an extension described in subsection (a) is in effect or has expired; (2) a subsequent application filed with re- spect 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, deliv- ery device, or strength; (3) a product that does not meet the defini- tion 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 submis- sion of such a request, determine whether the drug is a qualified infectious disease product. (2) Limitation Except as provided in paragraph (3), a des- ignation under this subsection shall not be withdrawn for any reason, including modifica- tions 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 imple- menting this section, including developing the list of qualifying pathogens described in sub- section (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 regula- tion; 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 infec- tious disease product described in subsection (g). (f) Qualifying pathogen (1) Definition In this section, the term ‘‘qualifying patho- gen’’ 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, in- cluding methicillin-resistant Staphy- lococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-re- sistant 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 main- tain 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, includ- ing the Centers for Disease Control and Prevention, the Food and Drug Adminis- tration, medical professionals, and the clinical research community. (C) Review Every 5 years, or more often as needed, the Secretary shall review, provide modifica- Page 262 TITLE 21—FOOD AND DRUGS § 355g tions 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 prod- uct’’ means a drug (including a biological prod- uct), 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 infec- tion caused by— (A) an antibacterial or antifungal resist- ant pathogen, including novel or emerging infectious pathogens; or (B) qualifying pathogens listed by the Sec- retary 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.) Editorial Notes AMENDMENTS 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 sub- sec. (g) generally. Prior to amendment, text read as fol- lows: ‘‘The term ‘qualified infectious disease product’ means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infec- tions, including those caused by— ‘‘(1) an antibacterial or antifungal resistant patho- gen, including novel or emerging infectious patho- gens; or ‘‘(2) qualifying pathogens listed by the Secretary under subsection (f).’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE 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].’’ § 355g. Utilizing real world evidence (a) In general The Secretary shall establish a program to evaluate the potential use of real world evi- dence— (1) to help to support the approval of a new indication for a drug approved under section 355(c) of this title; and (2) to help to support or satisfy postapproval study requirements. (b) Real world evidence defined In this section, the term ‘‘real world evidence’’ means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. (c) Program framework (1) In general Not later than 2 years after December 13, 2016, the Secretary shall establish a draft framework for implementation of the program under this section. (2) Contents of framework The framework shall include information de- scribing— (A) the sources of real world evidence, in- cluding ongoing safety surveillance, observa- tional studies, registries, claims, and pa- tient-centered outcomes research activities; (B) the gaps in data collection activities; (C) the standards and methodologies for collection and analysis of real world evi- dence; and (D) the priority areas, remaining chal- lenges, and potential pilot opportunities that the program established under this sec- tion will address. (3) Consultation (A) In general In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, rep- resentatives of patient advocacy organiza- tions, consumer organizations, disease re- search foundations, and other interested par- ties. (B) Process The consultation under subparagraph (A) may be carried out through approaches such as— (i) a public-private partnership with the entities described in such subparagraph in which the Secretary may participate; (ii) a contract, grant, or other arrange- ment, as the Secretary determines appro- priate, with such a partnership or an inde- pendent research organization; or (iii) public workshops with the entities described in such subparagraph. (d) Program implementation The Secretary shall, not later than 3 years after December 13, 2016, and in accordance with the framework established under subsection (c), implement the program to evaluate the poten- tial use of real world evidence. (e) Guidance for industry The Secretary shall— (1) utilize the program established under subsection (a), its activities, and any subse- quent pilots or written reports, to inform a guidance for industry on— (A) the circumstances under which spon- sors of drugs and the Secretary may rely on real world evidence for the purposes de- scribed in paragraphs (1) and (2) of sub- section (a); and (B) the appropriate standards and meth- odologies for collection and analysis of real world evidence submitted for such purposes; (2) not later than 5 years after December 13, 2016, issue draft guidance for industry as de- scribed in paragraph (1); and