SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Section 506(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(a)(1)) re-
quires the Secretary of Health and Human Services, 
at the request of the sponsor of a new drug, to ‘‘fa-
cilitate the development and expedite the review of 
such drug if it is intended for the treatment of a se-
rious or life-threatening condition and it dem-
onstrates the potential to address unmet medical 
needs for such a condition’’, designating such a drug 
to be a ‘‘fast track product’’. 
(2) Section 506(b)(1) of such Act, however, 
provides that the Secretary need not approve an ap-
plication for approval of a fast track product, even 
though the Secretary has determined ‘‘that the prod-
uct has an effect on a clinical endpoint or on a sur-
rogate endpoint that is reasonably likely to predict 
clinical benefit’’. 
(3) Section 312.34(a) of title 21, of the Code 
of Federal Regulations, provides for treatment use 
of a new drug, although such ‘‘drug . . . is not yet 
approved for marketing,’’ but is ‘‘under clinical in-
vestigation for a serious or immediately life-threat-
ening disease condition in patients for whom no 
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comparable or satisfactory alternative drug or other 
therapy is available’’. 
(4) Although the stated purpose of both current 
law and regulations, as stated under section 
312.34(a) of such title, is ‘‘to facilitate the avail-
ability of promising new drugs to desperately ill pa-
tients as early in the drug development process as 
possible, before general marketing begins’’, in prac-
tice applications for approval of promising therapies 
intended to treat such desperately ill patients suf-
fering from serious and immediately life-threatening 
diseases for whom no comparable or alternative drug 
or other therapy is available have encountered un-
justified delays and denials. 
(5) As a consequence of such delays and denials 
of applications for such treatment use, desperately ill 
patients suffering from serious and immediately life- 
threatening disease conditions have been denied the 
last, and perhaps the only, best chance for treatment 
protocols that might have saved their lives. 
(6) Applications for such treatment use ought 
not be subject to the discretion of the Secretary, but 
should be granted, in all cases, if such applications 
meet the statutory criteria governing such applica-
tions. 
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(7) Applications for fast track product review 
ought not be subject to the discretion of the Sec-
retary, but should be granted, in all cases, if such 
applications meet the statutory criteria governing 
such applications as set forth in section 506(b)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356(b)(1)). 
SEC. 3. TREATMENT USE APPROVAL SYSTEM. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following new subsection: 
‘‘(v) TREATMENT USE
OF
AN INVESTIGATIONAL 
DRUG.— 
‘‘(1) IN
GENERAL.—A drug that is not ap-
proved for marketing, but is under clinical investiga-
tion for a serious or immediately life-threatening dis-
ease condition in patients for whom no comparable 
or satisfactory alternative drug or other therapy is 
available, shall be made available for treatment use 
by an individual patient if— 
‘‘(A) the drug is intended to treat a serious 
or immediately life-threatening disease condi-
tion; 
‘‘(B) there is no comparable or satisfactory 
alternative drug or other therapy available to 
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treat that stage of the disease in the person for 
whom the drug is intended; 
‘‘(C) the drug is under investigation in a 
controlled clinical trial as an investigational new 
drug under subsection (i) in effect for the trial 
or all clinical trials have been completed; and 
‘‘(D) an application for treatment use has 
been filed in writing with the Food and Drug 
Administration by a licensed practitioner and 
such application sets forth— 
‘‘(i) the specific intended use of the 
drug; 
‘‘(ii) an explanation of the rationale 
for use of the drug, including an expla-
nation as to why the use of the investiga-
tional drug is necessary in the treatment of 
the individual patient; 
‘‘(iii) a treatment protocol, including 
the method of the administration of the 
drug and dosages; 
‘‘(iv) a statement of the qualifications 
of the licensed practitioner to use the in-
vestigational drug for the intended treat-
ment use; 
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‘‘(v) a statement of the licensed prac-
titioner’s familiarity with information of 
the drug’s safety and effectiveness derived 
from previous clinical and nonclinical expe-
rience with the drug; and 
‘‘(vi) a signed and notarized state-
ment of the individual patient, or guard-
ian, if any, setting forth in detail— 
‘‘(I) the information about the 
drug’s safety and effectiveness; 
‘‘(II) risks disclosed to the pa-
tient; and 
‘‘(III) the patient’s informed con-
sent to the treatment protocol to be 
administered by the licensed practi-
tioner. 
‘‘(2) PERMISSION FOR TREATMENT USE.— 
‘‘(A) DEADLINE.—Within 30 days of the 
filing of an application for treatment use in 
compliance with paragraph (1), the Secretary 
shall grant permission to the sponsor of an in-
vestigational drug to furnish such drug to the 
submitting licensed practitioner under such 
terms as the sponsor, licensed practitioner, and 
patient determine among themselves to be ap-
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propriate, including any agreement to waive li-
ability. 
‘‘(B) TREATMENT
OF
EMERGENCIES.—If 
the need for an investigational drug arises in an 
emergency situation that does not allow time 
for submission of such an application for treat-
ment use in writing, such application may be 
transmitted to the Secretary by telephone or by 
other means of rapid communication, and shall 
be acted on rapidly, but in no case later than 
30 days after the date of receipt of the applica-
tion. 
‘‘(3) DEFINITIONS.—In paragraph (1)— 
‘‘(A) the term ‘serious’ means, with respect 
to a disease or condition, a disease or condition 
that causes major irreversible morbidity; and 
‘‘(B) the term ‘immediately life-threat-
ening’ means, with respect to a disease or con-
dition— 
‘‘(i) a disease or condition where the 
likelihood of death is high unless the 
course of the disease or condition is inter-
rupted; or 
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‘‘(ii) a disease or condition with po-
tentially fatal outcomes, where the end 
point of clinical trial analysis is survival.’’. 
SEC. 4. REMOVING DISCRETION IN APPROVAL OF APPLICA-
TION FOR FAST TRACK PRODUCTS. 
Section 506(b)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356(b)(1)) is amended by strik-
ing ‘‘may’’ and inserting ‘‘shall’’. 
Æ 
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