United States S 150: Affordable Prescriptions for Patients Act of 2023

Bill Text

II
118TH CONGRESS
1ST SESSION S. 150
To amend the Federal Trade Commission Act to prohibit product hopping,
and for other purposes.
IN THE SENATE OF THE UNITED STATES
JANUARY 30, 2023
Mr. CORNYN (for himself, Mr. BLUMENTHAL, Mr. GRASSLEY, Mr. DURBIN,
Mr. CRUZ, and Ms. KLOBUCHAR) introduced the following bill; which was
read twice and referred to the Committee on the Judiciary
A BILL
To amend the Federal Trade Commission Act to prohibit
product hopping, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Affordable Prescrip-4
tions for Patients Act of 2023’’. 5
SEC. 2. PRODUCT HOPPING. 6
(a) IN GENERAL.—The Federal Trade Commission 7
Act (15 U.S.C. 41 et seq.) is amended by inserting after 8
section 26 (15 U.S.C. 57c–2) the following: 9
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‘‘SEC. 27. PRODUCT HOPPING. 1
‘‘(a) DEFINITIONS.—In this section: 2
‘‘(1) ABBREVIATED NEW DRUG APPLICATION.— 3
The term ‘abbreviated new drug application’ means 4
any application under subsection (j) of section 505 5
of the Federal Food, Drug, and Cosmetic Act (21 6
U.S.C. 355) or an application under subsection 7
(b)(2) of such section 505 that seeks a therapeutic 8
equivalence rating to the reference product. 9
‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT.—The 10
term ‘biosimilar biological product’ means a biologi-11
cal product licensed under section 351(k) of the 12
Public Health Service Act (42 U.S.C. 262(k)). 13
‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LI-14
CENSE APPLICATION.—The term ‘biosimilar biologi-15
cal product license application’ means an application 16
submitted under section 351(k) of the Public Health 17
Service Act (42 U.S.C. 262(k)). 18
‘‘(4) FOLLOW-ON PRODUCT.—The term ‘follow- 19
on product’— 20
‘‘(A) means a drug approved through an 21
application or supplement to an application sub-22
mitted under section 505(b) of the Federal 23
Food, Drug, and Cosmetic Act (21 U.S.C. 24
355(b)) or a biological product licensed through 25
an application or supplement to an application 26
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submitted under section 351(a) of the Public 1
Health Service Act (42 U.S.C. 262(a)) for a 2
change or modification to, or reformulation of, 3
the same manufacturer’s previously approved 4
drug or biological product that has an indica-5
tion that is identical or substantively similar to 6
an indication of the same manufacturer’s pre-7
viously approved drug or biological product; and 8
‘‘(B) excludes such an application or sup-9
plement to an application for a change, modi-10
fication, or reformulation of a drug or biological 11
product that is requested by the Secretary or 12
necessary to comply with law, including sections 13
505A and 505B of the Federal Food, Drug, 14
and Cosmetic Act (21 U.S.C. 355a, 355c). 15
‘‘(5) GENERIC DRUG.—The term ‘generic drug’ 16
means any drug approved under an application sub-17
mitted under subsection (j) of section 505 of the 18
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 19
355) or an application under subsection (b)(2) of 20
such section 505 that seeks a therapeutic equiva-21
lence rating to the reference product. 22
‘‘(6) LISTED DRUG.—The term ‘listed drug’ 23
means a drug listed under section 505(j)(7) of the 24
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 1
355(j)(7)). 2
‘‘(7) MANUFACTURER.—The term ‘manufac-3
turer’ means the holder, licensee, or assignee of— 4
‘‘(A) an approved application for a drug 5
under section 505(c) of the Federal Food, 6
Drug, and Cosmetic Act (21 U.S.C. 355(c)); or 7
‘‘(B) a biological product license under sec-8
tion 351(a) of the Public Health Service Act 9
(42 U.S.C. 262(a)). 10
‘‘(8) REFERENCE PRODUCT.—The term ‘ref-11
erence product’ has the meaning given the term in 12
section 351(i) of the Public Health Service Act (42 13
U.S.C. 262(i)). 14
‘‘(9) ULTIMATE PARENT ENTITY.—The term 15
‘ultimate parent entity’ has the meaning given the 16
term in section 801.1 of title 16, Code of Federal 17
Regulations, or any successor regulation. 18
‘‘(b) PROHIBITION ON PRODUCT HOPPING.— 19
‘‘(1) PRIMA FACIE.—A manufacturer of a ref-20
erence product or listed drug shall be considered to 21
have engaged in an unfair method of competition in 22
or affecting commerce in violation of section 5(a) if 23
complaint counsel or the Commission demonstrates 24
in an action or proceeding initiated by the Commis-25
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