21 USC 360bbb-0a - Investigational drugs for use by eligible patients

U.S Code last checked for updates: Nov 22, 2024

§ 360bbb–0a.

Investigational drugs for use by eligible patients

(a)

Definitions

For purposes of this section—

(1)

the term “eligible patient” means a patient—

(A)

who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations));

(B)

who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who—

(i)

is in good standing with the physician’s licensing organization or board; and

(ii)

will not be compensated directly by the manufacturer for so certifying; and

(C)

who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent;

(2)

the term “eligible investigational drug” means an investigational drug (as such term is used in section 360bbb of this title)—

(A)

for which a Phase 1 clinical trial has been completed;

(B)

that has not been approved or licensed for any use under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262];

(C)

(i)

for which an application has been filed under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]; or

(ii)

that is under investigation in a clinical trial that—

(I)

is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; and

(II)

is the subject of an active investigational new drug application under

or section 351(a)(3) of the Public Health Service Act [

(D)

the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 355(i) of this title; and

(3)

the term “phase 1 trial” means a phase 1 clinical investigation of a drug as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).

(b)

Exemptions

(c)

Use of clinical outcomes

(1)

In general

Notwithstanding any other provision of this chapter, the Public Health Service Act [42 U.S.C. 201 et seq.], or any other provision of Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] unless—

(A)

the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or

(B)

the sponsor requests use of such outcomes.

(2)

Limitation

(d)

Reporting

(1)

In general

(2)

Posting of information

The Secretary shall post an annual summary report of the use of this section on the internet website of the Food and Drug Administration, including the number of drugs for which clinical outcomes associated with the use of an eligible investigational drug pursuant to this section was—

(A)

used in accordance with subsection (c)(1)(A);

(B)

used in accordance with subsection (c)(1)(B); and

(C)

not used in the review of an application under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(June 25, 1938, ch. 675, § 561B, as added Pub. L. 115–176, § 2(a), May 30, 2018, 132 Stat. 1372.)

cite as: 21 USC 360bbb-0a