21 U.S.C. § 357 — Qualification of drug development tools

(a) The qualification process: (1) The Secretary must set up a process for "qualifying" drug development tools for a specific proposed use, in three steps: (A) a requestor starts by submitting a letter of intent, which the Secretary accepts or declines; (B) if accepted, the requestor submits a qualification plan, which the Secretary accepts or declines; and (C) if that is accepted, the requestor submits a full qualification package, the Secretary decides whether to accept it for review, and if accepted, reviews it under this section. (2) Handling submissions: (A) this covers how the Secretary treats a letter of intent, a qualification plan, or a full qualification package (together called "qualification submissions"); (B) the Secretary decides whether to accept a submission based on factors that may include its scientific merit — but declining to accept a submission is not a final ruling on whether the tool actually qualifies; (C) the Secretary may prioritize reviewing a full qualification package based on factors like the severity, rarity, or prevalence of the disease it targets and whether alternative treatments exist, or whether the Secretary or expert biomedical research groups have flagged it as a public health priority; (D) for reviewing submissions, the Secretary may consult biomedical research consortia — through grants, cooperative agreements, or similar tools — and may consider their recommendations on a qualification plan or a full qualification package. (3) The Secretary must (A) thoroughly review an accepted full qualification package, and (B) decide whether the tool is qualified for its proposed use. (4) The Secretary bases the qualification decision on the scientific merit shown in the reviewed full qualification package. (b) What qualification means: (1) A tool found qualified under (a)(4), for the specific proposed use the requestor named, may then be used by anyone for that use, for the purposes in (2). (2) Subject to (3), a qualified tool may be used to (A) support or obtain approval or licensing of a drug or biological product, including through the accelerated-approval process, or (B) support investigational use of a drug or biological product. (3) Rescinding or modifying qualification: (A) the Secretary may withdraw or change a qualification if it turns out the tool is not appropriate for its proposed use — including based on new information calling the original qualification into question. (B) If the Secretary does this, the requestor is entitled, on request, to a meeting to discuss the Secretary's reasoning before the change takes effect. (c) Transparency: (1) Subject to (3), the Secretary must post on the FDA's website — updated at least twice a year — (A) information about each qualification submission, including its stage in the review process, the date it last changed stage, whether outside scientific experts were used in developing a qualification plan or reviewing a full package, and the submissions themselves (including their data and evidence, and any updates); (B) the Secretary's formal written decisions responding to those submissions; (C) any rescissions or modifications of a qualification decision; (D) summary reviews explaining the conclusions and recommendations behind qualification decisions; and (E) a complete list of (i) every tool qualified under (a), and (ii) every surrogate endpoint that was the basis for approving or licensing a drug or biological product, including under the accelerated-approval process. (2) Making this information public counts as a disclosure authorized by law for purposes of the criminal trade-secrets statute. (3) Limits: (A) nothing here requires the Secretary to disclose (i) confidential commercial or trade-secret information from an approval application that is protected under the Freedom of Information Act or the trade-secrets statute, or (ii) for a tool tied to a countermeasure against bioterrorism, other security threats, or pandemics or epidemics, information the Secretary decides has significant potential to affect national security. (B) If the Secretary withholds information under (A)(ii), the FDA website must still publicly acknowledge that some information was not disclosed, and why (A)(ii) applies. (d) Nothing in this section changes (1) the evidence standards — including the "substantial evidence" standard — used for approving drugs or biologics, or (2) the Secretary's existing authority to approve or license products, as that authority stood before December 13, 2016. (e) Definitions: (1) "Biomarker" (A) means an objectively measured and evaluated characteristic — such as a physiologic, pathologic, or anatomic one — used as an indicator of normal biological processes, disease processes, or the body's response to a treatment; and (B) includes a surrogate endpoint. (2) "Biomedical research consortia" means collaborative groups, possibly structured as public-private partnerships, that may include government agencies, colleges and universities, patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant participants. (3) "Clinical outcome assessment" means (A) a measurement of a patient's symptoms, overall mental state, or how a disease affects their functioning, and (B) includes a patient-reported outcome. (4) "Context of use" means, for a drug development tool, the specific circumstances under which it will be used in drug development and regulatory review. (5) "Drug development tool" includes (A) a biomarker, (B) a clinical outcome assessment, and (C) any other method, material, or measure the Secretary decides helps drug development and regulatory review for this section's purposes. (6) "Patient-reported outcome" means a measurement based on a report directly from the patient about their health condition, without any amendment or interpretation by a clinician or anyone else. (7) "Qualification" and "qualified" mean the Secretary's determination that a drug development tool, and its proposed use, can be relied on to have a specific interpretation and application in drug development and regulatory review. (8) "Requestor" means an entity or entities — including a drug sponsor or a biomedical research consortium — seeking to qualify a tool for a proposed use. (9) "Surrogate endpoint" means a marker — such as a lab measurement, radiographic image, or physical sign — that is not itself a direct measure of clinical benefit, and that either (A) is known to predict clinical benefit and can support standard approval of a drug or biological product, or (B) is reasonably likely to predict clinical benefit and can support accelerated approval.

The record indicates that this section was not part of the original Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), but was added later as section 507 of that Act by Public Law 114–255, division A, title III, § 3011(a), enacted December 13, 2016. The source credit further shows that the provision was subsequently amended once, by Public Law 116–22, title VII, § 705(e), enacted June 24, 2019. Beyond these two legislative actions, the credit does not describe the substance of the amendment or further amendment history. Historical context: Public Law 114–255 is widely known as the 21st Century Cures Act, a broad piece of legislation enacted in December 2016 addressing biomedical innovation, medical product development, and regulatory modernization at the Food and Drug Administration. The Act is generally understood to have aimed at accelerating the discovery, development, and delivery of new treatments by, among other things, establishing clearer pathways for evaluating tools used in drug development. Public Law 116–22 is commonly known as the SUPPORT for Patients and Communities Act, primarily associated with the federal response to the opioid crisis, though it also contained miscellaneous amendments to other health-related statutes. The specific reasons Congress chose to structure this particular provision as it did, including the qualification process, transparency requirements, and definitions, are not established by the source credit, and the record does not provide section-specific legislative intent beyond what can be inferred from the general purposes of the enacting Act.