195 
cleared, granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of this Act 
or section 351 of the Public Health Service Act (as appli-
cable), provided— 
‘‘(A) the product information includes— 
‘‘(i) a clear statement that the investiga-
tional drug or device or investigational use of a 
drug or device has not been approved, cleared, 
granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of 
this Act or section 351 of the Public Health 
Service Act (as applicable) and that the safety 
and effectiveness of the drug or device or use 
has not been established; 
‘‘(ii) information related to the stage of de-
velopment of the drug or device involved, such 
as— 
‘‘(I) the status of any study or studies 
in which the investigational drug or device 
or investigational use is being investigated; 
‘‘(II) how the study or studies relate 
to the overall plan for the development of 
the drug or device; and 
‘‘(III) whether an application, pre-
market notification, or request for classi-
196 
fication for the investigational drug or de-
vice or investigational use has been sub-
mitted to the Secretary and when such a 
submission is planned; 
‘‘(iii) in the case of information that in-
cludes factual presentations of results from 
studies, which shall not be selectively presented, 
a description of— 
‘‘(I) all material aspects of study de-
sign, methodology, and results; and 
‘‘(II) all material limitations related 
to the study design, methodology, and re-
sults; 
‘‘(iv) where applicable, a prominent state-
ment disclosing the indication or indications for 
which the Secretary has approved, granted mar-
keting authorization, cleared, or licensed the 
product pursuant to section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of 
the Public Health Service Act, and a copy of 
the most current required labeling; and 
‘‘(v) updated information, if previously 
communicated information becomes materially 
outdated as a result of significant changes or as
197 
a result of new information regarding the prod-
uct or its review status; and 
‘‘(B) the product information does not in-
clude— 
‘‘(i) information that represents that an 
unapproved product— 
‘‘(I) has been approved, cleared, 
granted marketing authorization, or li-
censed 
under 
section 
505, 
510(k), 
513(f)(2), or 515 of this Act or section 
351 of the Public Health Service Act (as 
applicable); or 
‘‘(II) has otherwise been determined 
to be safe or effective for the purpose or 
purposes for which the drug or device is 
being studied; or 
‘‘(ii) information that represents that an 
unapproved use of a drug or device that has 
been so approved, granted marketing authoriza-
tion, cleared, or licensed— 
‘‘(I) is so approved, granted mar-
keting authorization, cleared, or licensed; 
or
198 
‘‘(II) that the product is safe or effec-
tive for the use or uses for which the drug 
or device is being studied. 
‘‘(2) For purposes of this paragraph, the term ‘prod-
uct information’ includes— 
‘‘(A) information describing the drug or device 
(such as drug class, device description, and fea-
tures); 
‘‘(B) information about the indication or indica-
tions being investigated; 
‘‘(C) the anticipated timeline for a possible ap-
proval, clearance, marketing authorization, or licen-
sure pursuant to section 505, 510(k), 513, or 515 
of this Act or section 351 of the Public Health Serv-
ice Act; 
‘‘(D) drug or device pricing information; 
‘‘(E) patient utilization projections; 
‘‘(F) product-related programs or services; and 
‘‘(G) factual presentations of results from stud-
ies that do not characterize or make conclusions re-
garding safety or efficacy.’’. 
(b) GAO STUDY AND REPORT.—Beginning on the 
date that is 5 years and 6 months after the date of enact-
ment of this Act, the Comptroller General of the United 
States shall conduct a study on the provision and use of
199 
information pursuant to section 502(gg) of the Federal 
Food, Drug, and Cosmetic Act, as added by this sub-
section (a), between manufacturers of drugs and devices 
(as defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321)) and entities described in 
such section 502(gg). Such study shall include an analysis 
of the following: 
(1) The types of information communicated be-
tween such manufacturers and payors. 
(2) The manner of communication between 
such manufacturers and payors. 
(3)(A) Whether such manufacturers file an ap-
plication for approval, marketing authorization, 
clearance, or licensing of a new drug or device or the 
new use of a drug or device that is the subject of 
communication between such manufacturers and 
payors under section 502(gg) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a). 
(B) How frequently the Food and Drug Admin-
istration approves, grants marketing authorization, 
clears, or licenses the new drug or device or new use. 
(C) The timeframe between the initial commu-
nications permitted under section 502(gg) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a), regarding an investigational drug or