I 
110TH CONGRESS 
1ST SESSION H. R. 1038 
To amend the Public Health Service Act to provide for the licensing of 
comparable and interchangeable biological products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 14, 2007 
Mr. WAXMAN (for himself, Mrs. EMERSON, Mr. PALLONE, Mr. EMANUEL, and 
Ms. HIRONO) introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committee 
on the Judiciary, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend the Public Health Service Act to provide for 
the licensing of comparable and interchangeable biologi-
cal products, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Access to Life-Saving 
Medicine Act’’. 
SEC. 2. DEFINITIONS. 
(a) AMENDMENTS.—Section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(i)) is amended— 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
(1) by striking ‘‘In this section, the term ‘bio-
logical product’ means’’ and inserting the following: 
‘‘In this section: 
‘‘(1) The term ‘biological product’ means’’; and 
(2) by adding at the end the following: 
‘‘(2) The term ‘abbreviated biological product 
application’ means an abbreviated application for a 
license of a biological product containing the same, 
or similar, active ingredient as a reference product. 
‘‘(3) The term ‘reference product’ means the 
single licensed biological product, approved under 
subsection (a) or subsection (k), against which a bio-
logical product is evaluated for demonstration of 
safety, potency, or purity. 
‘‘(4) The term ‘comparable’ or ‘comparability’ 
in reference to a biological product means the ab-
sence of clinically meaningful differences between 
the biological product and the reference product in 
terms of the safety, purity, and potency of the prod-
uct based upon— 
‘‘(A) data derived from chemical, physical, 
and biological assays, and other non-clinical 
laboratory studies; and 
‘‘(B) data from any necessary clinical 
study or studies sufficient to confirm safety, 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
purity, and potency in one or more appropriate 
conditions of use for which the reference prod-
uct is licensed and intended to be used. 
Any studies under subparagraph (B) shall be de-
signed to avoid duplicative and unethical clinical 
testing. 
‘‘(5) The terms ‘interchangeable’ and ‘inter-
changeability’ mean, with respect to the condition of 
use involved, that the biological product— 
‘‘(A) is comparable to the reference prod-
uct; and 
‘‘(B) can be expected to produce the same 
clinical result as the reference product in any 
given patient. 
‘‘(6) The term ‘thorough characterization’ 
means an analysis of structural features based upon 
appropriate analytical and functional testing suffi-
cient to identify differences between a biological 
product and reference product relevant to safety, pu-
rity or potency. 
‘‘(7) The term ‘final action’ means, with respect 
to an abbreviated biological product application, the 
Secretary’s issuance of a final action letter to the 
sponsor of an abbreviated biological product applica-
tion which— 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS