SEC. 2. FACILITATING EXCHANGE OF INFORMATION PRIOR 
TO APPROVAL. 
Section 502(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(a)) is amended— 
(1) by redesignating subparagraph (2) as sub-
paragraph (3); 
(2) by inserting after subparagraph (1) the fol-
lowing: 
‘‘(2)(A) Health care economic information, scientific 
information, or product support information provided to 
a covered payor responsible for the selection of drugs or 
devices for coverage, reimbursement, or other population- 
based health care management, shall not be considered 
false or misleading or any other form of misbranding 
under this section or a violation of section 505, 510(k), 
513, or 515 of this Act or section 351 of the Public Health 
Service Act, or otherwise prohibited pre-approval pro-
motion of a drug or device, if it— 
‘‘(i)(I) in the case of health care economic in-
formation, is based on competent and reliable sci-
entific evidence; or 
‘‘(II) in the case of scientific information other 
than health care economic information, is truthful 
and nonmisleading; and 
‘‘(ii) relates to an investigational drug or device 
or investigational use of a drug or device that is ap-
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proved, cleared, or licensed under section 505, 
510(k), 513, or 515 of this Act or section 351 of the 
Public Health Service Act (as applicable). 
‘‘(B) In order to provide information pursuant to this 
subparagraph relating to an investigational drug or device, 
or an investigational use of an drug or device that has 
been approved, granted marketing authorization, cleared, 
or licensed— 
‘‘(i) the information must include— 
‘‘(I) a clear statement that the investiga-
tional drug or device or investigational use of a 
drug or device has not been approved, cleared, 
or licensed under section 505, 510(k), 513, 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 yet been established; 
‘‘(II) information related to the stage of 
development of the drug or device involved, 
such as— 
‘‘(aa) the status of any study or stud-
ies in which the investigational drug or de-
vice or investigational use is being inves-
tigated; 
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‘‘(bb) how the study or studies relate 
to the overall plan for the development of 
the drug or device; 
‘‘(cc) whether a marketing application 
or notification for the investigational drug 
or device or investigational use has been 
submitted to the Secretary and when such 
a submission is planned; 
‘‘(III) in the case of communications that 
include factual presentations of results from 
studies, a description of— 
‘‘(aa) material aspects of study de-
sign, methodology, and results; and 
‘‘(bb) material limitations related to 
the study design, methodology, and results; 
and 
‘‘(IV) where applicable, a conspicuous and 
prominent statement describing any material 
differences between the information provided 
and the labeling approved, granted marketing 
authorization, cleared, or licensed pursuant to 
section 505, 510(k), 513, or 515 of this Act or 
section 351 of the Public Health Service Act. 
‘‘(C) For purposes of this subparagraph— 
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‘‘(i) the term ‘covered payor’ means a payor, 
formulary committee, drug information center, tech-
nology assessment committee, pharmacy benefit 
manager, and other multidisciplinary entity that, on 
behalf of health care organizations, reviews scientific 
or technology assessments, or other similar entity 
with knowledge and expertise to evaluate health care 
economic analysis or scientific information on a pop-
ulation basis; 
‘‘(ii) the term ‘product support information’ in-
cludes— 
‘‘(I) information describing the drug or de-
vice (such as drug class, device description, and 
features); 
‘‘(II) information about the indication or 
indications sought; 
‘‘(III) the anticipated timeline for a pos-
sible approval, clearance, or licensure pursuant 
to section 505, 510(k), 513, or 515 of this Act 
or section 351 of the Public Health Service Act; 
‘‘(IV) drug or device pricing information; 
‘‘(V) patient utilization projections; and 
‘‘(VI) product-related programs or services. 
‘‘(iii) the term ‘scientific information’ includes 
clinical and pre-clinical data and results relating to 
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