Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)). 
‘‘(7) MANUFACTURER.—The term ‘manufac-
turer’ means the holder, licensee, or assignee of— 
‘‘(A) an approved application for a drug 
under section 505(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(c)); or 
‘‘(B) a biological product license under sec-
tion 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)). 
‘‘(8) REFERENCE
PRODUCT.—The term ‘ref-
erence product’ has the meaning given the term in 
section 351(i) of the Public Health Service Act (42 
U.S.C. 262(i)). 
‘‘(9) ULTIMATE
PARENT
ENTITY.—The term 
‘ultimate parent entity’ has the meaning given the 
term in section 801.1 of title 16, Code of Federal 
Regulations, or any successor regulation. 
‘‘(b) PROHIBITION ON PRODUCT HOPPING.— 
‘‘(1) PRIMA FACIE.—A manufacturer of a ref-
erence product or listed drug shall be considered to 
have engaged in an unfair method of competition in 
or affecting commerce in violation of section 5(a) if 
complaint counsel or the Commission demonstrates 
in an action or proceeding initiated by the Commis-
VerDate Sep 11 2014 
02:52 Jun 08, 2021
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2873.IH
H2873
kjohnson on DSK79L0C42PROD with BILLS
sion under subsection (c) that, during the period be-
ginning on the date on which the manufacturer of 
the reference product or listed drug first receives no-
tice that an applicant has submitted to the Commis-
sioner of Food and Drugs an abbreviated new drug 
application or biosimilar biological product license 
application referencing the reference product or list-
ed drug and ending on the date that is the earlier 
of 180 days after the date on which that generic 
drug or biosimilar biological product or another ge-
neric drug or biosimilar biological product ref-
erencing the listed drug or reference product is first 
marketed or 3 years after the date on which the fol-
low-on product is first marketed, the manufacturer 
engaged in either of the following actions: 
‘‘(A) The manufacturer engaged in a hard 
switch, which shall be established by dem-
onstrating that the manufacturer engaged in ei-
ther of the following actions: 
‘‘(i) Upon the request of the manufac-
turer of the listed drug or reference prod-
uct, the Commissioner of Food and Drugs 
withdrew the approval of the application 
for the listed drug or reference product or 
placed the listed drug or reference product 
VerDate Sep 11 2014 
02:52 Jun 08, 2021
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2873.IH
H2873
kjohnson on DSK79L0C42PROD with BILLS
on the discontinued products list and the 
manufacturer marketed or sold a follow-on 
product. 
‘‘(ii) The manufacturer of the listed 
drug or reference product— 
‘‘(I)(aa) withdrew, discontinued 
the manufacture of, or announced 
withdrawal of, discontinuance of the 
manufacture of, or intent to withdraw 
the application with respect to the 
drug or reference product in a manner 
that impedes competition from a ge-
neric drug or a biosimilar biological 
product, which may be established by 
objective circumstances, unless such 
actions were taken by the manufac-
turer pursuant to a request of the 
Commissioner of Food and Drugs; or 
‘‘(bb) destroyed the inventory of 
the listed drug or reference product in 
a manner that impedes competition 
from a generic drug or a biosimilar bi-
ological product, which may be estab-
lished by objective circumstances; and 
VerDate Sep 11 2014 
02:52 Jun 08, 2021
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2873.IH
H2873
kjohnson on DSK79L0C42PROD with BILLS
‘‘(II) marketed or sold a follow-on 
product. 
‘‘(B) The manufacturer engaged in a soft 
switch, which shall be established by dem-
onstrating that the manufacturer engaged in 
both of the following actions: 
‘‘(i) The manufacturer took actions 
with respect to the listed drug or reference 
product other than those described in sub-
paragraph (A) that unfairly disadvantage 
the listed drug or reference product rel-
ative to the follow-on product described in 
clause (ii) in a manner that impedes com-
petition from a generic drug or a bio-
similar biological product, which may be 
established by objective circumstances. 
‘‘(ii) The manufacturer marketed or 
sold a follow-on product. 
‘‘(2) EXCLUSIONS.—Nothing in this section 
shall prohibit actions that consist solely of— 
‘‘(A) truthful, non-misleading promotional 
marketing; or 
‘‘(B) ceasing promotional marketing for 
the listed drug or reference product. 
‘‘(3) JUSTIFICATION.— 
VerDate Sep 11 2014 
02:52 Jun 08, 2021
Jkt 019200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2873.IH
H2873
kjohnson on DSK79L0C42PROD with BILLS
‘‘(A) IN GENERAL.—Subject to paragraph 
(4), the actions described in paragraph (1) by 
a manufacturer of a listed drug or reference 
product shall not be considered to be an unfair 
method of competition in or affecting commerce 
if the manufacturer demonstrates to the Com-
mission or a district court of the United States, 
as applicable, in an action, suit or proceeding 
initiated by the Commission under subsection 
(c)(1) that— 
‘‘(i) the manufacturer would have 
taken the actions regardless of whether a 
generic drug that references the listed drug 
or biosimilar biological product that ref-
erences the reference product had already 
entered the market; and 
‘‘(ii)(I) with respect to a hard switch 
under paragraph (1)(A), the manufacturer 
took the action for reasons relating to the 
safety risk to patients of the listed drug or 
reference product; 
‘‘(II) with respect to an action de-
scribed 
in 
item 
(aa) 
of 
paragraph 
(1)(A)(ii)(I), there is a supply disruption 
that— 
VerDate Sep 11 2014 
02:52 Jun 08, 2021
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2873.IH
H2873
kjohnson on DSK79L0C42PROD with BILLS
‘‘(aa) is outside of the control of 
the manufacturer; 
‘‘(bb) prevents the production or 
distribution of the applicable listed 
drug or reference product; and 
‘‘(cc) cannot be remedied by rea-
sonable efforts; or 
‘‘(III) with respect to a soft switch 
under paragraph (1)(B), the manufacturer 
had legitimate pro-competitive reasons, 
apart from the financial effects of reduced 
competition, to take the action. 
‘‘(B) RULE OF CONSTRUCTION.—Nothing 
in subparagraph (A) may be construed to limit 
the information that the Commission may oth-
erwise obtain in any proceeding or action insti-
tuted with respect to a violation of this section. 
‘‘(4) RESPONSE.—With respect to a justifica-
tion offered by a manufacturer under paragraph (3), 
the Commission may— 
‘‘(A) rebut any evidence presented by a 
manufacturer during that justification; or 
‘‘(B) establish by a preponderance of the 
evidence that— 
VerDate Sep 11 2014 
02:52 Jun 08, 2021
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H2873.IH
H2873
kjohnson on DSK79L0C42PROD with BILLS