
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360bbb]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
        Part E--General Provisions Relating to Drugs and Devices
 
Sec. 360bbb. Expanded access to unapproved therapies and 
        diagnostics
        

(a) Emergency situations

    The Secretary may, under appropriate conditions determined by the 
Secretary, authorize the shipment of investigational drugs or 
investigational devices for the diagnosis, monitoring, or treatment of a 
serious disease or condition in emergency situations.

(b) Individual patient access to investigational products intended for 
        serious diseases

    Any person, acting through a physician licensed in accordance with 
State law, may request from a manufacturer or distributor, and any 
manufacturer or distributor may, after complying with the provisions of 
this subsection, provide to such physician an investigational drug or 
investigational device for the diagnosis, monitoring, or treatment of a 
serious disease or condition if--
        (1) the licensed physician determines that the person has no 
    comparable or satisfactory alternative therapy available to 
    diagnose, monitor, or treat the disease or condition involved, and 
    that the probable risk to the person from the investigational drug 
    or investigational device is not greater than the probable risk from 
    the disease or condition;
        (2) the Secretary determines that there is sufficient evidence 
    of safety and effectiveness to support the use of the 
    investigational drug or investigational device in the case described 
    in paragraph (1);
        (3) the Secretary determines that provision of the 
    investigational drug or investigational device will not interfere 
    with the initiation, conduct, or completion of clinical 
    investigations to support marketing approval; and
        (4) the sponsor, or clinical investigator, of the 
    investigational drug or investigational device submits to the 
    Secretary a clinical protocol consistent with the provisions of 
    section 355(i) or 360j(g) of this title, including any regulations 
    promulgated under section 355(i) or 360j(g) of this title, 
    describing the use of the investigational drug or investigational 
    device in a single patient or a small group of patients.

(c) Treatment investigational new drug applications and treatment 
        investigational device exemptions

    Upon submission by a sponsor or a physician of a protocol intended 
to provide widespread access to an investigational drug or 
investigational device for eligible patients (referred to in this 
subsection as an ``expanded access protocol''), the Secretary shall 
permit such investigational drug or investigational device to be made 
available for expanded access under a treatment investigational new drug 
application or treatment investigational device exemption if the 
Secretary determines that--
        (1) under the treatment investigational new drug application or 
    treatment investigational device exemption, the investigational drug 
    or investigational device is intended for use in the diagnosis, 
    monitoring, or treatment of a serious or immediately life-
    threatening disease or condition;
        (2) there is no comparable or satisfactory alternative therapy 
    available to diagnose, monitor, or treat that stage of disease or 
    condition in the population of patients to which the investigational 
    drug or investigational device is intended to be administered;
        (3)(A) the investigational drug or investigational device is 
    under investigation in a controlled clinical trial for the use 
    described in paragraph (1) under an investigational drug application 
    in effect under section 355(i) of this title or investigational 
    device exemption in effect under section 360j(g) of this title; or
        (B) all clinical trials necessary for approval of that use of 
    the investigational drug or investigational device have been 
    completed;
        (4) the sponsor of the controlled clinical trials is actively 
    pursuing marketing approval of the investigational drug or 
    investigational device for the use described in paragraph (1) with 
    due diligence;
        (5) in the case of an investigational drug or investigational 
    device described in paragraph (3)(A), the provision of the 
    investigational drug or investigational device will not interfere 
    with the enrollment of patients in ongoing clinical investigations 
    under section 355(i) or 360j(g) of this title;
        (6) in the case of serious diseases, there is sufficient 
    evidence of safety and effectiveness to support the use described in 
    paragraph (1); and
        (7) in the case of immediately life-threatening diseases, the 
    available scientific evidence, taken as a whole, provides a 
    reasonable basis to conclude that the investigational drug or 
    investigational device may be effective for its intended use and 
    would not expose patients to an unreasonable and significant risk of 
    illness or injury.

A protocol submitted under this subsection shall be subject to the 
provisions of section 355(i) or 360j(g) of this title, including 
regulations promulgated under section 355(i) or 360j(g) of this title. 
The Secretary may inform national, State, and local medical associations 
and societies, voluntary health associations, and other appropriate 
persons about the availability of an investigational drug or 
investigational device under expanded access protocols submitted under 
this subsection. The information provided by the Secretary, in 
accordance with the preceding sentence, shall be the same type of 
information that is required by section 282(j)(3) of title 42.

(d) Termination

    The Secretary may, at any time, with respect to a sponsor, 
physician, manufacturer, or distributor described in this section, 
terminate expanded access provided under this section for an 
investigational drug or investigational device if the requirements under 
this section are no longer met.

(e) Definitions

    In this section, the terms ``investigational drug'', 
``investigational device'', ``treatment investigational new drug 
application'', and ``treatment investigational device exemption'' shall 
have the meanings given the terms in regulations prescribed by the 
Secretary.

(June 25, 1938, ch. 675, Sec. 561, as added Pub. L. 105-115, title IV, 
Sec. 402, Nov. 21, 1997, 111 Stat. 2365.)


                             Effective Date

    Section effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as an Effective 
Date of 1997 Amendment note under section 321 of this title.

                  Section Referred to in Other Sections

    This section is referred to in title 42 section 282.
