121 
subsection (a)(1)) executed after the date of enact-
ment of this Act. 
SEC. 404. INCREASING GENERIC DRUG COMPETITION. 
(a) LISTING OF GENERIC DRUGS AT LIST OF BEING 
IN SHORTAGE.—Chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 506E the following: 
‘‘SEC. 506E–1. LISTING OF GENERIC DRUGS. 
‘‘(a) DATABASE FOR MANUFACTURERS OF GENERIC 
DRUGS.—The Commissioner shall— 
‘‘(1) not later than 9 months after the date of 
enactment of the Improving Access To Affordable 
Prescription Drugs Act, publish a complete, up-to- 
date list on the Internet website of the Food and 
Drug Administration of all generic drugs (including 
drug trade name, active pharmaceutical ingredient 
manufacturer, active finished dosage form manufac-
turer, any contract manufacturing organization, the 
date the authorized generic drug entered the market, 
and marketing status); 
‘‘(2) designate each drug on the list that is a 
sole-source drug; and 
‘‘(3) maintain a confidential list of the identity 
and address of each manufacturer and labeler asso-
ciated with a drug reported under this section, and 
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122 
publicly report on the website only the city and State 
or country of each such manufacturer and labeler. 
‘‘(b) PUBLIC HEALTH EXCEPTION.—The Commis-
sioner may choose not to make information collected under 
subsection (a) publicly available if the Secretary deter-
mines that disclosure of such information would adversely 
affect the public health (such as by increasing the possi-
bility of hoarding or other disruption of the availability 
of drug products to patients). 
‘‘(c) NOTIFICATION.—The Commissioner shall notify 
relevant Federal agencies, including the Centers for Medi-
care & Medicaid Services and the Federal Trade Commis-
sion, when the Commissioner first publishes the informa-
tion under subsection (a) that the information has been 
published and will be updated regularly. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘manufacturer’ means a person 
engaged in the manufacture of an active pharma-
ceutical ingredient or finished dosage form, as de-
fined in section 744A. 
‘‘(2) The term ‘sole-source’ means— 
‘‘(A) A drug for which there is only one 
approved manufacturer listed in the active sec-
tion of the Approved Drug Products With 
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123 
Therapeutic Equivalence Evaluations (com-
monly known as the ‘FDA Orange Book’); and 
‘‘(B) for which there are no blocking pat-
ents or exclusivities that may receive expedited 
review, except where the drug was approved 
pursuant to a suitability petition under section 
505(j)(2)(C).’’. 
(b) REPORT ON CONTRACTS.—Section 510(j) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)) 
is amended by adding at the end the following: 
‘‘(5) Each person who registers with the Secretary 
under this section shall report to the Secretary any con-
tract with a contract manufacturing organization with re-
spect to any drug such person manufacturers, distributes, 
or compounds, including the start date and end date of 
such contract.’’. 
(c) DISCONTINUANCE
OR INTERRUPTION
IN
THE 
PRODUCTION OF LIFE-SAVING DRUGS.—Section 506C(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c(a)) is amended by striking ‘‘of a drug—’’ and all 
that follows through the end of paragraph (2) and insert-
ing ‘‘of a drug’’. 
(d) DECREASE IN MANUFACTURERS OF DRUGS.— 
Chapter V of the Federal Food, Drug, and Cosmetic Act 
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124 
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
tion 506C–1 the following: 
‘‘SEC. 506C–2. DECREASE IN MANUFACTURERS OF GENERIC 
DRUGS. 
‘‘(a) IN GENERAL.—If the Secretary determines that 
the number of manufacturers of a drug approved under 
section 505 or a biological product licensed under section 
351 is less than 2, the Secretary may— 
‘‘(1) with respect to a manufacturer with fewer 
than 500 employees, including employees of affiliates 
of the manufacturer, waive the prescription drug ap-
plication fees under sections 736(a), 744B(a), or 
744H(a); 
‘‘(2) expedite the review of applications for the 
drug under section 505(j) or section 351(k) of the 
Public Health Service Act until the number of man-
ufacturers of the drug is at least 4; and 
‘‘(3) after consultation with the Federal Trade 
Commission to ensure that the manufacturer has not 
engaged in anticompetitive tactics to remove other 
manufacturers from the market in order to 
incentivize such a contract, establish and prioritize 
purchase contracts with manufacturers who are 
holders of applications approved under section 
505(j) or section 351(k) of the Public Health Serv-
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125 
ice Act for the drug but who are not currently man-
ufacturing such drug. 
‘‘(b) GUIDELINES FOR PURCHASE CONTRACTS.— 
‘‘(1) IN GENERAL.—The Secretary shall pro-
mulgate regulations to establish guidelines for the 
drugs with respect to which the Secretary may es-
tablish purchase contracts in accordance with sub-
section (a)(3). Such guidelines shall provide that any 
such purchase contract may be only with respect to 
a drug that is listed as an essential medicine by the 
World Health Organization, or another external enti-
ty, as the Secretary may specify, that meets evi-
dence-based standards as the Secretary may require. 
‘‘(2) PRICING.—If a manufacturer enters into 
purchase contract in accordance with subsection 
(a)(3), the Secretary, in cooperation with the Office 
of the Inspector General, shall establish a limit on 
the retail price at which the drug may be made 
available to consumers in the United States.’’. 
SEC. 405. DISALLOWANCE OF DEDUCTION FOR ADVER-
TISING FOR PRESCRIPTION DRUGS. 
(a) IN GENERAL.—Part IX of subchapter B of chap-
ter 1 of subtitle A of the Internal Revenue Code of 1986 
(relating to items not deductible) is amended by adding 
at the end the following new section: 
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126 
‘‘SEC. 280I. DISALLOWANCE OF DEDUCTION FOR DIRECT- 
TO-CONSUMER ADVERTISING OF PRESCRIP-
TION DRUGS. 
‘‘(a) IN GENERAL.—No deduction shall be allowed 
under this chapter for expenses relating to direct-to-con-
sumer advertising of prescription drugs for any taxable 
year. 
‘‘(b) 
DIRECT-TO-CONSUMER
ADVERTISING.—For 
purposes of this section, the term ‘direct-to-consumer ad-
vertising’ means any dissemination, by or on behalf of a 
sponsor of a prescription drug product (as such term is 
defined in section 735(3) of the Federal Food, Drug, and 
Cosmetic Act), of an advertisement which— 
‘‘(1) is in regard to such prescription drug 
product, and 
‘‘(2) primarily targeted to the general public, 
including through— 
‘‘(A) publication in journals, magazines, 
other periodicals, and newspapers, 
‘‘(B) broadcasting through media such as 
radio, television, telephone communication sys-
tems, direct mail, and billboards, 
‘‘(C) dissemination on the Internet (includ-
ing social media); and 
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127 
‘‘(D) manufacturer patient assistance pro-
grams, as defined in section 399V–7 of the 
Public Health Service Act.’’. 
(b) CONFORMING AMENDMENT.—The table of sec-
tions for such part IX of the Internal Revenue Code of 
1986 is amended by adding after the item relating to sec-
tion 280H the following new item: 
‘‘Sec. 280I. Disallowance of deduction for direct-to-consumer advertising of pre-
scription drugs.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to amounts paid or incurred after 
the date of the enactment of this Act, in taxable years 
ending after such date. 
SEC. 406. PRODUCT HOPPING. 
(a) DEFINITIONS.—In this section— 
(1) the term ‘‘biological product’’ has the mean-
ing given that term in section 351 of the Public 
Health Service Act (42 U.S.C. 262); 
(2) the term ‘‘drug’’ has the meaning given that 
term in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321); and 
(3) the term ‘‘product hopping’’ means a cir-
cumstance in which— 
(A) a manufacturer reformulates a drug or 
biological product in such a way that allows the 
manufacturer to submit a new drug application 
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128 
under section 505(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(b)) or 
new application for a license under section 
351(a) of the Public Health Service Act (42 
U.S.C. 262(a)) with respect to such new formu-
lation; 
(B) the new formulation described in sub-
paragraph (A) is intended for the treatment of 
the same medical condition as the drug or bio-
logical product that was reformulated; and 
(C) actions are taken to reduce or elimi-
nate demand for the original drug or biological 
product. 
(b) REPORT.—The Federal Trade Commission shall 
submit to Congress a report on the extent to which— 
(1) manufacturers of drugs and biological prod-
ucts engage in product hopping, including an anal-
ysis of the timing of the introduction of the reformu-
lated product relative to the market entry of a drug 
approved under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act or biological product li-
censed under section 351(k) of the Public Health 
Service Act, the types of changes made in the new 
product, the patents and market exclusivities award-
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129 
ed to reformulated products, and the various forms 
of product hopping manufacturers employ; 
(2) manufacturers assess the profitability of a 
new product based whether it launches before (or 
how long before) generic entry occurs on the original 
product; 
(3) the effect of product-hopping behavior on 
consumers, including the total estimated annual cost 
to consumers of physicians prescribing the sub-
stituted drug in place of a generic version of the 
original product; 
(4) the effect of product-hopping on insurance 
prices and availability, including cost increases and 
coverage reductions attributable to the economic 
losses described in paragraph (3); 
(5) product hopping affects manufacturer prof-
its, revenues, unit sales, and prices; and 
(6) product hopping affects the unit sales, man-
ufacturer profits, and prices of the generic version of 
the original product. 
Æ 
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