21 U.S.C. § 360a–2 — Susceptibility test interpretive criteria for microorganisms

(a) Purpose; identification of criteria (1) Purpose This section makes clear the Secretary has authority to: (A) efficiently update the "susceptibility test interpretive criteria" used for antimicrobial drugs whenever public health requires it — because microorganisms keep evolving resistance to drugs that used to work, these drugs need special handling different from most other drugs, to delay or prevent more resistance; (B) publicly announce which interpretive criteria and standards are recognized; and (C) clear a device under section 360(k), classify one under section 360c(f)(2), or approve one under section 360e, when that device is an antimicrobial susceptibility testing device using updated, recognized criteria to show how susceptible certain bacteria, fungi, or other microorganisms are to antimicrobial drugs. (2) Identification of criteria The Secretary must identify the right susceptibility test interpretive criteria for an antimicrobial drug: (A) if criteria already exist when the drug is approved under section 355 or licensed under section 262 of title 42, right then; or (B) if they do not exist yet, as soon as they become available. (3) Bases for initial identification The Secretary identifies these criteria based on, to the extent available and relevant: (A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data; (B) how the criteria relate to the disease's rate of sickness and death; and (C) any other evidence the Secretary thinks is appropriate. (b) Susceptibility test Interpretive Criteria Website (1) In general Within 1 year of December 13, 2016, the Secretary must set up, and keep maintaining, a dedicated page on the FDA website — the "Interpretive Criteria Website" — listing new or updated susceptibility test interpretive criteria standards and criteria, as described in paragraph (2). (2) Listing (A) The main list covers new or updated standards that are (i) made by a nationally or internationally recognized standard-development organization that (I) has procedures to handle conflicts of interest and keep decisions transparent, (II) holds open meetings so the public can weigh in, and makes sure that input is actually considered, and (III) lets its standards be made publicly available, for example through the National Library of Medicine; and that are (ii) recognized, in whole or in part, by the Secretary under subsection (c). (B) A second list covers criteria the Secretary has decided are appropriate for legally marketed antimicrobial drugs, used when (i) the Secretary does not recognize an otherwise-applicable standard, in whole or in part; (ii) the Secretary has withdrawn recognition of a standard, in whole or in part; (iii) the Secretary approved a drug application and no recognized criteria exist for it; or (iv) a drug's characteristics differ enough from other drugs with the same active ingredient that different criteria apply, and the Secretary decides that is appropriate. (C) The website must include statements explaining (i) that it shows lab (in vitro) susceptibility information about certain microorganisms to a given drug; (ii) that the safety and effectiveness of that drug in treating real infections from those microorganisms may or may not have been proven in adequate, well-controlled trials, and that the clinical meaning of the susceptibility information may be unknown; (iii) that the drug's approved labeling shows what uses the Secretary has actually approved; and (iv) any other information the Secretary thinks is needed to explain the data. (3) Notice The Secretary must publish a Federal Register notice when the website is set up. (4) Inapplicability of misbranding provision Putting a reference or link to the website in a drug's approved labeling does not, by itself, make the drug misbranded under section 352. (5) Trade secrets and confidential information Nothing here lets the Secretary disclose trade secrets or confidential information protected under section 552(b)(4) of title 5. (c) Recognition of susceptibility test interpretive criteria (1) Evaluation and publication (A) Starting when the website is set up, and at least every 6 months after that, the Secretary must (i) evaluate new or updated standards from the recognized standard-development organizations described in (b)(2)(A)(i); and (ii) publish a notice that (I) withdraws recognition of a different standard, in whole or in part; (II) recognizes the new or updated standard; (III) recognizes part of new or updated criteria while declining to recognize the rest; and (IV) updates the lists from (b)(2) as needed. (B) When the Secretary approves a drug application based on criteria that differ from a recognized or listed standard, or where none exist yet, the Secretary must update the lists in (b)(2)(A) and (B) to add the criteria the approval relied on. (2) Bases for updating interpretive criteria standards In evaluating standards under (1)(A), the Secretary may consider: (A) that a standard does not apply to a particular drug because that drug differs from others with the same active ingredient; (B) information from interested outside parties, including public comments; (C) the same bases used to identify criteria under (a)(2); and (D) any other information or factors the Secretary thinks are appropriate. (3) Annual compilation of notices Each year, the Secretary must gather up the notices published under (1)(A), publish that compilation in the Federal Register, and take public comment. If comments come in, the Secretary must review them and, where appropriate, update the standards or criteria recognized under this subsection or listed on the website under (b)(2). (4) Relation to section 360d(c) of this title A standard recognized under this subsection, or criteria otherwise listed under (b)(2)(B), counts as "recognized" for purposes of section 360d(c)(1). (5) Voluntary use of interpretive criteria Nothing here stops someone from seeking approval or clearance of a drug or device, or a change to one, based on susceptibility test interpretive criteria that differ from the ones recognized or listed by the Secretary. (d) Antimicrobial drug labeling (1) Drugs marketed prior to establishment of Interpretive Criteria Website (A) For an antimicrobial drug already being sold before the website was set up, the holder of its approved application must, within 1 year of the website's launch, remove the susceptibility test interpretive criteria and related information from the drug's approved labeling and put in a reference to the website instead. (B) This labeling change counts as a "minor change" under section 314.70 of title 21 of the Code of Federal Regulations, and can be reported in the next annual report. (2) Drugs marketed subsequent to establishment of Interpretive Criteria Website For antimicrobial drugs approved on or after the website's launch date, the drug's labeling must include a reference to the website in place of the susceptibility test interpretive criteria and related information. (e) Special condition for marketing of antimicrobial susceptibility testing devices (1) In general Even though sections 351, 352, 355, 360, 360c, and 360e normally apply, if the conditions in paragraph (2) are met, along with other applicable rules, the Secretary may authorize marketing of a device described in subsection (f)(1) for the use described there. (2) Conditions applicable to antimicrobial susceptibility testing devices The conditions are: (A) the device determines susceptibility using criteria that are either (i) part of a standard the Secretary recognized under subsection (c), or (ii) otherwise listed on the website under (b)(2); (B) the device's labeling states (i) that it gives lab (in vitro) susceptibility information about certain microorganisms to antimicrobial drugs; (ii) that the safety and effectiveness of those drugs in treating real infections from those microorganisms may or may not have been proven in adequate, well-controlled trials for the device to report that susceptibility, and that the clinical meaning of the information in such cases is unknown; (iii) that the approved labeling for the tested drugs shows what uses the Secretary has actually approved; and (iv) any other information the Secretary decides is needed to explain the data; and (C) the device also meets every other requirement to be cleared under section 360(k), classified under section 360c(f)(2), or approved under section 360e. (f) Definitions (1) An "antimicrobial susceptibility testing device" is a device that uses susceptibility test interpretive criteria to determine and report how susceptible certain microorganisms are to a drug. (2) A "qualified infectious disease product" is one designated under section 355f(d). (3) "Susceptibility test interpretive criteria" means (A) specific numerical values that describe how susceptible bacteria or other microorganisms are to the tested drug, and (B) related categories, such as susceptible, intermediate, or resistant, or any other term the Secretary decides to use. (4) (A) Subject to (B), an "antimicrobial drug" is a systemic antibacterial or antifungal drug that (i) is meant for human use to treat a disease or condition caused by a bacterium or fungus, (ii) may include a qualified infectious disease product designated under section 355f(d), and (iii) is prescription-only under section 353(b)(1). (B) By regulation, the Secretary may expand this term to also include (i) drugs other than systemic antibacterial and antifungal drugs, and (ii) biological products, as defined in section 262 of title 42, that show antimicrobial activity. (5) An "interpretive criteria standard" is a compilation of susceptibility test interpretive criteria put together by a standard-development organization that meets the criteria in (b)(2)(A)(i). (g) Rule of construction Nothing in this section: (1) changes the standards of evidence under section 355(c) or (d) — including the substantial evidence standard — or under section 262 of title 42; or (2), when it comes to clearing devices under section 360(k), classifying them under section 360c(f)(2), or approving them under section 360e — (A) applies to any drug, device, or biological product outside the specific context of an antimicrobial drug and an antimicrobial susceptibility testing device using these criteria to reflect patient sickness and death rates as this section describes; or (B) unless the section specifically says so, affects any authority given under other sections of this chapter, including regulations issued under them.