‘‘SEC. 399V–7. DRUG MANUFACTURER REPORTING. 
‘‘(a) MANDATORY REPORTING.—A drug manufac-
turer shall submit to the Secretary and to Congress an 
annual report specifying with respect to the previous cal-
endar year (except as provided in subsection (d)(2))— 
‘‘(1) the total expenditures of the manufacturer 
on— 
‘‘(A) domestic and foreign drug research 
and development, including an itemized descrip-
tion of— 
‘‘(i) basic and preclinical research; 
‘‘(ii) clinical research, reported sepa-
rately for each clinical trial; 
‘‘(iii) development of alternative dos-
age forms and strengths for the drug mol-
ecule or combinations, including the mol-
ecule; 
‘‘(iv) other drug development activi-
ties, such as nonclinical laboratory studies 
and record and report maintenance; 
‘‘(v) pursuing new or expanded indica-
tions for such drug through supplemental 
applications under section 505 of the Fed-
eral Food, Drug, and Cosmetic Act; 
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‘‘(vi) carrying out postmarket require-
ments related to such drug, including 
under section 505(o)(3) of such Act; 
‘‘(vii) carrying out risk evaluation and 
mitigation strategies in accordance with 
section 505–1 of such Act; and 
‘‘(viii) marketing research; 
‘‘(B) the acquisition of drug components 
and packaging, in total and per unit sold, bro-
ken out by source and cost and identifying spe-
cific costs that reflect internal transfers within 
the manufacturer’s company; 
‘‘(C) other acquisitions relating to drugs, 
including for the purchase of patents and li-
censing or the acquisition of any corporate enti-
ty owning any rights to a drug during or after 
development of the drug; and 
‘‘(D) marketing, advertising, and educating 
for the promotion of a drug, including a break-
down of amounts aimed at consumers, pre-
scribers, managed care organizations, and oth-
ers, irrespective of whether a particular drug is 
mentioned in the marketing, advertising, or 
educating; 
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‘‘(2) the gross revenue, net revenue, gross prof-
it, and net profit of the manufacturer with respect 
to drugs; 
‘‘(3) the total number of units of each type of 
drug that were sold in interstate commerce; 
‘‘(4) pricing information with respect to the sale 
of drugs, including— 
‘‘(A) wholesale acquisition cost; 
‘‘(B) net average price realized by pre-
scription drug benefit managers for drugs pro-
vided to individuals in the United States, after 
accounting for any rebates or other payments 
from the manufacturer to the pharmacy benefit 
manager and from the pharmacy benefit man-
ager to the manufacturer; and 
‘‘(C) the net price of each drug, after ac-
counting for discounts, rebates, or other finan-
cial considerations, charged to purchasers in 
each applicable country of the Organisation for 
Economic Co-operation and Development; 
‘‘(5) any Federal benefits received by the manu-
facturer with respect to a drug, including the 
amounts and periods of impact for each such ben-
efit, including tax credits; Federal grants, including 
from the National Institutes of Health, the Depart-
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ment of Defense, the Department of Energy, the 
Centers for Disease Control and Prevention, or other 
Federal departments or agencies; patent applications 
that benefitted from such grants; patent extensions; 
exclusivity periods; and waivers of fees; 
‘‘(6) the percentage of research and develop-
ment expenditures described in clauses (i) through 
(v) of paragraph (1)(A) that were derived from Fed-
eral funds; 
‘‘(7) executive compensation for the chief execu-
tive officer, chief financial officer, and the 3 other 
most highly compensated executive officers, includ-
ing bonuses, paid by such manufacturer, and stock 
options affiliated with the manufacturer that were 
offered to or accrued by such officers; and 
‘‘(8) any other information as the Secretary 
may require. 
‘‘(b) VOLUNTARY SUPPLEMENTAL REPORTING.—A 
drug manufacturer may supplement a report under sub-
section (a) with any additional information the manufac-
turer chooses to provide related to drug pricing decisions, 
such as— 
‘‘(1) total expenditures on drug research, drug 
development, and clinical trials on drugs that failed 
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to receive approval by the Food and Drug Adminis-
tration; and 
‘‘(2) a list of drugs and drug prices of other 
manufacturers for purposes of comparison with the 
manufacturer’s own drugs and drug prices. 
‘‘(c) SPECIAL RULE.—A drug manufacturer shall— 
‘‘(1) to the extent possible, disaggregate the in-
formation required to be reported by this section by 
the particular drug involved; and 
‘‘(2) submit all information required to be re-
ported by this section with respect to each applicable 
drug in a single annual report. 
‘‘(d) SUBMISSION OF REPORTS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) SUBMISSION BY DRUG MANUFACTUR-
ERS.—Drug manufacturers shall submit the an-
nual reports required under this section to the 
Secretary in a usable format, as the Secretary 
may require. 
‘‘(B) COLLATION BY THE SECRETARY.— 
The Secretary shall collate the reports received 
as described in subparagraph (A) and submit 
such collated reports to Congress, together with 
an analysis of the reports by the Secretary that 
includes— 
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‘‘(i) a summary of data from the re-
ports; 
‘‘(ii) consideration of factors such as 
trends on research and development costs, 
Federal benefits, and manufacturer patient 
assistance programs; and 
‘‘(iii) the relationship between the fac-
tors described in clause (ii) and prescrip-
tion drug prices. 
‘‘(C) PUBLIC
AVAILABILITY.—The Sec-
retary shall make the reports submitted by 
manufacturers as described in subparagraph 
(A) and the collated reports together with the 
analysis of the Secretary described in subpara-
graph (B) publicly available, including by post-
ing such reports to the internet website of the 
Department of Health and Human Services, in 
a searchable format. 
‘‘(2) INITIAL REPORT.— 
‘‘(A) IN GENERAL.—A drug manufacturer 
shall submit an initial report pursuant to this 
section not later than one year after the date of 
enactment of this subparagraph (except as pro-
vided in subparagraph (B)). 
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paragraph (A) shall be submitted by a date de-
termined by the Secretary, which shall be— 
‘‘(i) not earlier than the deadline de-
scribed in subparagraph (A); and 
‘‘(ii) not later than the date that is 3 
years after the date of enactment of this 
clause. 
‘‘(e) AUDIT BY THIRD PARTY.—The Secretary shall 
select a percentage (to be determined by the Secretary) 
of the reports submitted under subsection (a) for a fiscal 
year to be audited by an accredited third-party auditor 
(to be selected by the Secretary). 
‘‘(f) PENALTY
FOR NONCOMPLIANCE.—The Sec-
retary shall report to the Office of the Inspector General 
any manufacturer’s failure to submit a complete report as 
required under this section. Any manufacturer that fails 
to submit a complete report required under this section 
shall be subject to a civil penalty of up to $200,000 for 
each day on which the violation continues. The Secretary 
shall collect the civil penalties under this subsection and, 
without further appropriation, shall use such funds to sup-
port research of the National Institutes of Health. 
‘‘(g) DEFINITION.—In this section, the term ‘drug 
manufacturer’ means the manufacturer of an approved 
drug (including a drug approved under subsection (c) or 
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(j) of section 505 of the Federal Food, Drug, and Cos-
metic Act and a biological product licensed under sub-
section (a) or (k) of section 351 of this Act).’’. 
Æ 
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