21 U.S.C. § 360bbb–0: Expanded access policy…

Summary

Manufacturers and distributors must publish and make easy-to-find their policy for handling patient requests to get investigational drugs for serious diseases. The policy should be public, for example on a website, and it can cover all their investigational drugs. The policy must give contact details, explain how to ask for the drug, describe the basic rules the company will use to decide and respond, say how long they expect to take to acknowledge a request, and include a link or reference to the required clinical trial record. Posting the policy does not guarantee any patient will get the drug. Companies can change the policy anytime. The rule applies starting at the earlier of the first start of a phase 2 or phase 3 study, or 15 days after the drug gets a breakthrough, fast track, or regenerative advanced therapy designation.

Title 21, §360bbb–0

Food and Drugs, Source: USLM XML via OLRC

(a)In general

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)Public availability of expanded access policy

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)Content of policy

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)No guarantee of access

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)Revised policy

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

(f)Application

This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the earlier of— (1)

(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