‘‘(A) shall not alter the text of the sum-
mary statement; and 
‘‘(B) may prepare a description of changes 
to the summary statement in a separate docu-
ment and attach the document as an addendum 
to the summary statement. 
‘‘(5) CONFIDENTIAL INFORMATION.—This sub-
section does not authorize the disclosure of any 
trade secret or privileged or confidential commercial 
or 
financial 
information 
described 
in 
section 
552(b)(4) of title 5, United States Code, unless the 
Secretary determines that such disclosure is nec-
essary to protect the public health.’’. 
SEC. 8. BIENNIAL REPORTS ON APPROVED APPLICATIONS 
SUPPORTED BY NON-INFERIORITY STUDIES. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 7 of this Act, is amended by 
adding at the end the following subsection: 
‘‘(q) BIENNIAL REPORTS ON APPROVED APPLICA-
TIONS SUPPORTED BY NON-INFERIORITY STUDIES.—The 
Secretary shall submit to the Congress biennial reports on 
approved applications under subsection (b) (including sup-
plemental applications) that have been supported by data 
from one or more non-inferiority studies. For each such 
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application, the report shall include the following informa-
tion: 
‘‘(1) The name of the drug listed in application. 
‘‘(2) The name of the sponsor. 
‘‘(3) The date of the approval. 
‘‘(4) The name of each drug used as an active 
control in the non-inferiority studies used to support 
the application. 
‘‘(5) The indication studied. 
‘‘(6) The primary and secondary endpoints of 
the non-inferiority studies. 
‘‘(7) The margins used in such studies. 
‘‘(8) The explanation required by section 
314.l26(b)(2)(iv) of title 21, Code of Federal Regu-
lations, as to why the drugs should be considered ef-
fective in the study.’’. 
SEC. 9. BIANNUAL REPORTS REGARDING POSTMARKET 
STUDIES. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 8 of this Act, is amended by 
adding at the end the following subsection: 
‘‘(r) BIANNUAL REPORTS REGARDING POSTMARKET 
STUDIES.—The Secretary shall submit to the Congress bi-
annual reports that provide the following information: 
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‘‘(1) The number of enforcement actions taken 
to ensure that sponsors are complying with the re-
quirements to complete postmarketing studies under 
subsection (o) and sections 505C and 506(b)(2), to-
gether with a description of each such action. 
‘‘(2) The measures taken by the Secretary to 
establish a system to ensure effective monitoring of 
the status of all such postmarketing studies, to-
gether with a description of the status of that sys-
tem. 
‘‘(3) The measures taken by the Secretary to 
develop a system to track information about ongoing 
postmarketing safety issues, together with a descrip-
tion of the status of that system.’’. 
Æ 
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