110 HR 6047 IH: Early Access to Treatment
U.S. House of Representatives
2008-05-14
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EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the
Early Access to Treatment
Act
.
2.Congress finds the following:
(1)Section 506(a)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)(1)) requires the
Secretary of Health and Human Services, at the request of the sponsor of a new
drug, to facilitate the development and expedite the review of such drug
if it is intended for the treatment of a serious or life-threatening condition
and it demonstrates 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
application for approval of a fast track product, even though the Secretary has
determined that the product has an effect on a clinical endpoint or on a
surrogate 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 investigation for a serious or
immediately life-threatening disease condition in patients for whom no
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 availability of promising
new drugs to desperately ill patients as early in the drug development process
as possible, before general marketing begins
, in practice applications
for approval of promising therapies intended to treat such desperately ill
patients suffering from serious and immediately life-threatening diseases for
whom no comparable or alternative drug or other therapy is available have
encountered unjustified 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 applications.
(7)Applications for
fast track product review 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 applications as set forth in section
506(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(b)(1)).
3.Treatment use
approval systemSection 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)A drug that is not approved for marketing, but is under
clinical investigation for a serious or immediately life-threatening disease
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
condition;
(B)there is no
comparable or satisfactory alternative drug or other therapy available to 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 explanation as to why the use
of the investigational 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
investigational drug for the intended treatment use;
(v)a
statement of the licensed practitioner’s familiarity with information of the
drug’s safety and effectiveness derived from previous clinical and nonclinical
experience with the drug; and
(vi)a
signed and notarized statement of the individual patient, or guardian, if any,
setting forth in detail—
(I)the information
about the drug’s safety and effectiveness;
(II)risks disclosed to
the patient; and
(III)the patient’s
informed consent to the treatment protocol to be administered by the licensed
practitioner.
(2)Permission for
treatment use
(A)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 investigational 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
appropriate, including any agreement to waive liability.
(B)If the need for an investigational drug arises in an
emergency situation that does not allow time for submission of such an
application for treatment 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 application.
(3)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-threatening means, with respect to a disease or
condition—
(i)a
disease or condition where the likelihood of death is high unless the course of
the disease or condition is interrupted; or
(ii)a
disease or condition with potentially fatal outcomes, where the end point of
clinical trial analysis is
survival.
.
4.Removing
discretion in approval of application for fast track productsSection 506(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356(b)(1)) is amended by striking
may
and inserting shall
.