§360bbb–0 — Title 21 Food and Drugs | U.S. Code

Summary

Companies that make or sell experimental drugs for serious illnesses must have and share a clear policy about how they handle requests to give those drugs to patients outside of clinical trials. The policy must be easy to find, for example on a public website, and can apply to all the company’s investigational drugs. The policy must list contact information; how to send a request; the basic rules the company will use to review and answer requests; how long the company expects to take to acknowledge a request; and a link to the drug’s clinical trial record. Posting the policy does not promise any patient will get the drug. Companies may change the policy at any time. The rule starts when a drug begins a phase 2 or phase 3 study, or 15 days after it is given breakthrough, fast track, or regenerative advanced therapy designation.

Title 21, §360bbb–0

Food and Drugs — Source: USLM XML via OLRC

(a)The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 360bbb(b) of this title for provision of such a drug.

(b)The policies under subsection (a) shall be made public and readily available, such as by posting such policies on a publicly available Internet website. Such policies may be generally applicable to all investigational drugs of such manufacturer or distributor.

(c)A policy described in subsection (a) shall include—

(1)contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);

(2)procedures for making such requests;

(3)the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients, and for responses to such requests;

(4)the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests; and

(5)a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section 282(j)(2)(A)(ii)(II)(gg) of title 42.

(d)The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

(e)Nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time.

(f)This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the earlier of—

(1)the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational drug; or

(2)as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 356 of this title.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2017—Subsec. (f). Pub. L. 115–52 substituted “earlier” for “later” in introductory provisions, added par. (2), redesignated former par. (2) as (1), and struck out former par. (1) which read as follows: “the date that is 60 calendar days after December 13, 2016; or”.

§360bbb–0 Expanded access policy required for investigational drugs

Summary

Title 21, §360bbb–0

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata