I 
114TH CONGRESS 
1ST SESSION H. R. 1576 
To require a study by the Government Accountability Office (GAO) to assess 
the Food and Drug Administration’s current regulatory pathway for 
reviewing generic versions of nonbiologic complex drug products, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 24, 2015 
Mr. BURGESS (for himself, Mr. BUTTERFIELD, Mr. ASHFORD, and Mr. BILI-
RAKIS) introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To require a study by the Government Accountability Office 
(GAO) to assess the Food and Drug Administration’s 
current regulatory pathway for reviewing generic versions 
of nonbiologic complex drug products, and for other pur-
poses. 
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 ‘‘Generic Complex 
Drugs Safety and Effectiveness for Patients Act of 2015’’. 
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SEC. 2. GAO STUDY OF SCIENTIFIC ISSUES REGARDING 
THE CURRENT REGULATORY PATHWAY FOR 
REVIEWING GENERIC VERSIONS OF CERTAIN 
COMPLEX DRUG PRODUCTS. 
(a) STUDY BY GAO.—The Comptroller General of 
the United States shall conduct a study to determine the 
following: 
(1) With respect to nonbiologic complex drug 
products that have not been fully characterized (as 
defined in subsection (e)(1)), whether the listing of 
such drugs as reference products in generic drug ap-
plications presents unique challenges in meeting ap-
proval standards that are significantly different than 
the challenges presented by generic drug applica-
tions that list small-molecule reference products. 
(2) With respect to biological products that are 
within the scope of the exception under section 
7002(e)(2) of Public Law 111–148 (relating to tem-
porary authority for the approval of biological prod-
ucts under section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355)), whether the 
listing of such biological products as reference prod-
ucts in generic drug applications presents unique 
challenges in meeting approval standards that are 
significantly different than the challenges presented 
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by generic drug applications that list small-molecule 
reference products. 
(3) If the answer to the question under para-
graph (1) or (2) is that significantly different chal-
lenges are presented for patients when reference 
products are nonbiologic complex drug products that 
have not been fully characterized or when reference 
products are biological products that are within the 
scope of the exception under section 7002(e)(2) of 
Public Law 111–148: 
(A) What degree of characterization of the 
proposed generic version and the reference 
product should be required in order to deter-
mine the safety and effectiveness of the generic 
version. 
(B) What degree of similarity should be re-
quired to deem that the active ingredient of the 
proposed generic version is the same as the ac-
tive ingredient of the reference product. 
(C) What types of evidence should be re-
quired to demonstrate that the proposed generic 
version is bioequivalent to the reference prod-
uct. 
(D) What requirements should be estab-
lished with respect to the comparability of the 
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manufacturing process for the proposed generic 
version and the manufacturing process for the 
reference product. 
(E) Whether and to what extent clinical 
evidence is needed to demonstrate that there is 
no difference in immunogenicity between the 
proposed generic version and the reference 
product. 
(F) Whether and to what extent other clin-
ical evidence is needed to demonstrate that the 
proposed generic version is as safe and effective 
for patients as the reference product. 
(G) Taking into account the determina-
tions made regarding the issues listed in sub-
paragraphs (A) through (F): 
(i) Whether section 505(j) of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) should be amended to es-
tablish provisions that expressly address 
the approval of copy versions of nonbio-
logic complex drug products that have not 
been fully characterized, provisions that ex-
pressly address the approval of copy 
versions of biological products that are 
within the scope of the exception under 
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section 7002(e)(2) of Public Law 111–148, 
or both. 
(ii) Whether section 505(b)(2) of such 
Act (21 U.S.C. 355(b)(2)) should be so 
amended. 
(iii) Whether such Act should other-
wise be so amended. 
(iv) Whether section 351 of the Public 
Health Service Act (42 U.S.C. 262) should 
be so amended. 
(H) Taking into account the determina-
tions made regarding the issues listed in sub-
paragraphs (A) through (F), and taking into 
consideration all relevant guidances, draft guid-
ances, and other agency policy documents— 
(i) whether the Food and Drug Ad-
ministration should develop and provide to 
the public a policy document that provides 
a comprehensive statement of general prin-
ciples on the evidence that is necessary to 
obtain the approval of such Administration 
for proposed generic versions of reference 
products that are nonbiologic complex drug 
products that have not been fully charac-
terized or that are biological products; and 
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(ii) if so, the date by which such Ad-
ministration could reasonably be expected 
to issue such comprehensive policy docu-
ment. 
(b) CONSULTATION.—The Comptroller General shall 
conduct the study under subsection (a) in consultation 
with— 
(1) the Secretary of Health and Human Serv-
ices, acting through the Commissioner of Food and 
Drugs; and 
(2) appropriate public and private entities, in-
cluding patient advocacy organizations, professional 
medical associations, hospital pharmacies, scientists 
of academic and business organizations, and rep-
resentatives of the regulated industry. 
(c) REQUIRED CONSIDERATION.—In carrying out the 
study under subsection (a), the Comptroller General shall 
consider the following: 
(1) Published clinical reports of clinically mean-
ingful (including serious) adverse events of patients 
to— 
(A) generic versions of the nonbiologic 
complex drug products that have not been fully 
characterized; 
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