163 
‘‘(c) RULE OF CONSTRUCTION.—This section shall 
not be construed to diminish the authority of the Secretary 
to prohibit or regulate direct-to-consumer advertising of 
drugs under other provisions of law.’’. 
SEC. 310. REPORTING ON JUSTIFICATION FOR DRUG PRICE 
INCREASES. 
Title III of the Public Health Service Act (42 U.S.C. 
241 et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART W—DRUG PRICE REPORTING; DRUG 
VALUE FUND 
‘‘SEC. 399OO. REPORTING ON JUSTIFICATION FOR DRUG 
PRICE INCREASES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) MANUFACTURER.—The term ‘manufac-
turer’ means the person— 
‘‘(A) that holds the application for a drug 
approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act or the license 
issued under section 351 of the Public Health 
Service Act; or 
‘‘(B) who is responsible for setting the 
price for the drug. 
‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 
drug’ means any drug that is approved under sub-
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section (c) or (j) of section 505 of the Federal Food, 
Drug, and Cosmetic Act or licensed under subsection 
(a) or (k) of section 351 of this Act— 
‘‘(A) that has a wholesale acquisition cost 
of $100 or more per month supply or per a 
course of treatment that lasts less than a 
month and is— 
‘‘(i)(I) subject to section 503(b)(1) of 
the Federal Food, Drug, and Cosmetic 
Act; or 
‘‘(II) commonly administered by 
hospitals (as determined by the Sec-
retary); 
‘‘(ii) not designated as a drug for a 
rare disease or condition under section 526 
of the Federal Food, Drug, and Cosmetic 
Act; and 
‘‘(iii) not designated by the Secretary 
as a vaccine; and 
‘‘(B) for which, during the previous cal-
endar year, at least 1 dollar of the total amount 
of sales were for individuals enrolled under the 
Medicare program under title XVIII of the So-
cial Security Act (42 U.S.C. 1395 et seq.) or 
under a State Medicaid plan under title XIX of 
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such Act (42 U.S.C. 1396 et seq.) or under a 
waiver of such plan. 
‘‘(3) WHOLESALE
ACQUISITION
COST.—The 
term ‘wholesale acquisition cost’ has the meaning 
given that term in section 1847A(c)(6)(B) of the So-
cial Security Act (42 U.S.C. 1395w–3a(c)(6)(B)). 
‘‘(b) REPORT.— 
‘‘(1) REPORT REQUIRED.—The manufacturer of 
a qualifying drug shall submit a report to the Sec-
retary for each price increase of a qualifying drug 
that will result in an increase in the wholesale acqui-
sition cost of that drug that is equal to— 
‘‘(A) 10 percent or more over a 12-month 
period; or 
‘‘(B) 25 percent or more over a 36-month 
period. 
‘‘(2) REPORT
DEADLINE.—Each report de-
scribed in paragraph (1) shall be submitted to the 
Secretary not later than 30 days prior to the 
planned effective date of such price increase. 
‘‘(c) CONTENTS.—A report under subsection (b) 
shall, at a minimum, include— 
‘‘(1) with respect to the qualifying drug— 
‘‘(A) the percentage by which the manufac-
turer will raise the wholesale acquisition cost of 
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the drug on the planned effective date of such 
price increase; 
‘‘(B) a justification for, and description of, 
each manufacturer’s price increase that will 
occur during the 12-month period described in 
subsection (b)(1)(A) or the 36-month period de-
scribed in subsection (b)(1)(B), as applicable; 
‘‘(C) the identity of the initial developer of 
the drug; 
‘‘(D) a description of the history of the 
manufacturer’s price increases for the drug 
since the approval of the application for the 
drug under section 505 of the Federal Food, 
Drug, and Cosmetic Act or the issuance of the 
license for the drug under section 351, or since 
the manufacturer acquired such approved appli-
cation or license; 
‘‘(E) the current list price of the drug; 
‘‘(F) the total expenditures of the manu-
facturer on— 
‘‘(i) materials and manufacturing for 
such drug; and 
‘‘(ii) acquiring patents and licensing 
for such drug; 
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‘‘(G) the percentage of total expenditures 
of the manufacturer on research and develop-
ment for such drug that was derived from Fed-
eral funds; 
‘‘(H) the total expenditures of the manu-
facturer on research and development for such 
drug that is used for— 
‘‘(i) basic and preclinical research; 
‘‘(ii) clinical research; 
‘‘(iii) new drug development; 
‘‘(iv) pursuing new or expanded indi-
cations for such drug through supple-
mental applications under section 505 of 
the Federal Food, Drug, and Cosmetic Act 
or section 351 of the Public Health Service 
Act; and 
‘‘(v) carrying out postmarket require-
ments related to such drug, including those 
under section 505(o)(3) of the Federal 
Food, Drug, and Cosmetic Act; 
‘‘(I) the total revenue and the net 
profit generated from the qualifying 
drug for each calendar year since the 
approval of the application for the 
drug under section 505 of the Federal 
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Food, Drug, and Cosmetic Act or the 
issuance of the license for the drug 
under section 351, or since the manu-
facturer acquired such approved appli-
cation or license; and 
‘‘(J) the total costs associated with mar-
keting and advertising for the qualifying drug; 
‘‘(2) with respect to the manufacturer— 
‘‘(A) the total revenue and the net profit 
of the manufacturer for each of the 12- and 36- 
month periods preceding the submission of the 
report; 
‘‘(B) all stock-based performance metrics 
used by the manufacturer to determine execu-
tive compensation for each of the 12- and 36- 
month periods preceding the submission of the 
report; and 
‘‘(C) any additional information the manu-
facturer chooses to provide related to drug pric-
ing decisions, such as total expenditures on— 
‘‘(i) drug research and development; 
or 
‘‘(ii) clinical trials on drugs that failed 
to receive approval by the Food and Drug 
Administration; and 
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