What This Bill Does
This bill changes how generic drug makers can get approval from the federal government. It allows certain generic drug applications to receive approval earlier, even when another company has the right to a 180-day period (a six-month waiting period before competitors can sell the same drug). The bill also requires the government to be more transparent about whether generic drugs match the ingredients of brand-name drugs.
##
Who It Affects
- Companies that manufacture generic drugs (non-brand-name versions of existing medications)
- The federal government's Food and Drug Administration (the agency that approves drugs)
- Patients who use generic medications
##
Key Provisions
- A generic drug company can receive approval for their application before the 180-day exclusivity period ends if the company promises in writing it will start selling the drug within 75 days of approval and meets other specific conditions (Sec. 2(a))
- If a company receives early approval but fails to actually sell the drug within 75 days, their approval automatically becomes temporary (tentative) again and they cannot get permanent approval unless they explain an unforeseeable problem prevented them from selling (Sec. 2(b))
- When a generic drug company asks, the government must tell them in writing whether their drug has the exact same active and inactive ingredients in the same amounts as the brand-name drug it copies, with specific details about any differences (Sec. 3(a))
- The government must publish guidance within one year explaining how it decides if generic drugs match brand-name drugs, including a 60-day public comment period (Sec. 3(b))
##
What Changes
If this becomes law, generic drug companies will be able to get approval and start selling drugs faster in some situations, rather than waiting for the full 180-day exclusivity period. Generic drug makers will also receive clearer information about ingredient requirements upfront, which may speed up the approval process. The government cannot change its decision about whether a generic drug matches a brand-name drug after approval unless the brand-name formulation changed for safety reasons or the government made an error.
##
Important Definitions
- **Abbreviated new drug application:** A faster approval process for generic drugs that don't require all the same testing as brand-name drugs because the original drug was already approved
- **180-day exclusivity period:** A six-month waiting period after a generic drug gets approved when the first company to file can sell without competition
- **Bioequivalence:** When a generic drug works in the body the same way as the brand-name version
- **Qualitatively and quantitatively the same:** Having identical active ingredients and non-active ingredients (fillers, binders, colorants) in identical amounts
##
Effective Date
The changes apply only to generic drug applications filed after the bill becomes law for drugs where no competing certification was filed before the bill becomes law. Not specified in bill text when the bill becomes law.
II
Calendar No. 108
118TH CONGRESS
1ST SESSION
S. 1114
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
180-day exclusivity period.
IN THE SENATE OF THE UNITED STATES
MARCH 30, 2023
Ms. SMITH (for herself and Mr. BRAUN) introduced the following bill; which
was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
JUNE 22, 2023
Reported by Mr. SANDERS, with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with
respect to the 180-day exclusivity period.
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 ‘‘Expanding Access to
4
Low-Cost Generics Act of 2023’’.
5
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•S 1114 RS
SEC. 2. 180-DAY EXCLUSIVITY PERIOD.
1
(a) IN GENERAL.—Section 505(j)(5)(B)(iv) of the
2
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
3
355(j)(5)(B)(iv)) is amended—
4
(1) in subclause (I)—
5
(A) by inserting ‘‘and subclause (III)’’
6
after ‘‘subparagraph (D)’’; and
7
(B) by inserting before the period at the
8
end the following: ‘‘or an applicant whose appli-
9
cation was approved pursuant to subclause
10
(III). If an applicant described in subclause
11
(III) is eligible for effective approval on the
12
same day a tentatively approved first applicant
13
who has requested final approval is determined
14
by the Secretary to be eligible for effective ap-
15
proval by meeting all the approval requirements
16
of this subsection, such applicant described in
17
subclause (III) may not receive effective ap-
18
proval until 180 days after the first applicant
19
begins commercial marketing of the drug.’’; and
20
(2) by adding at the end the following new sub-
21
clause:
22
‘‘(III) APPLICANT
APPROVAL.—The Sec-
23
retary may approve an application containing a
24
certification
described
in
paragraph
25
(2)(A)(vii)(IV) that is for a drug for which a
26
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•S 1114 RS
first applicant has submitted an application
1
containing such a certification, notwithstanding
2
the eligibility of a first applicant for the 180-
3
day exclusivity period described in subclause
4
(II)(aa), if each of the following conditions is
5
met:
6
‘‘(aa) The approval of such applica-
7
tion could be made effective, but for the
8
eligibility of a first applicant for 180-day
9
exclusivity under this clause.
10
‘‘(bb) The applicant of such applica-
11
tion has submitted a certification to the
12
abbreviated
new
drug
application
that
13
there are no conditions that would prevent
14
the applicant from commercial marketing
15
within 75 days after the date of approval
16
and that the applicant intends to so mar-
17
ket the drug.
18
‘‘(cc) At least 33 months have passed
19
since the date of submission of an applica-
20
tion for the drug by at least one first ap-
21
plicant.
22
‘‘(dd) Approval of an application for
23
the drug submitted by at least one first ap-
24
plicant is not precluded under clause (iii).
25
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•S 1114 RS
‘‘(ee) No application for the drug sub-
1
mitted by any first applicant is effectively
2
approved on the date that the conditions
3
under items (aa), (bb), (cc), and (dd) are
4
all met and maintained.’’.
5
(b) SPECIAL APPROVAL STATUS RULE FOR CERTAIN
6
SUBSEQUENT APPLICANTS.—Section 505(j)(5)(D) of the
7
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355
8
(j)(5)(D)) is amended at the end by adding the following:
9
‘‘(v)
SPECIAL
APPROVAL
STATUS
RULE
10
FOR CERTAIN SUBSEQUENT APPLICANTS.—An
11
application that is approved pursuant to sub-
12
clause (III) of subparagraph (B)(iv) is deemed
13
to be tentatively approved and to no longer
14
have an effective approval pursuant to such
15
subclause (III) on the date that is 76 days after
16
the date on which the approval has been made
17
effective pursuant to such subclause (III) if the
18
applicant fails to commercially market such
19
drug within the 75-day period after the date on
20
which the approval is made effective. If the ap-
21
plicant of an application approved pursuant to
22
such subclause (III) submits a notification that
23
it can no longer commence commercial mar-
24
keting within 75 days after the date of ap-
25
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•S 1114 RS
proval,
as
required
under
subparagraph
1
(B)(iv)(III)(bb), its application is deemed to be
2
tentatively approved and to no longer be effec-
3
tively approved on the date that such a notifica-
4
tion is received. If an applicant does not com-
5
mence commercial marketing within the 75-day
6
period, it shall not be eligible for a subsequent
7
effective approval for the application under sub-
8
clause (III) of subparagraph (B)(iv) unless, in
9
addition to meeting each of the conditions in
10
such subclause (III), it submits a certification
11
to its abbreviated new drug application that an
12
event that could not have been reasonably fore-
13
seen by the applicant prevented it from com-
14
mencing commercial marketing and that it has
15
fully resolved this issue. The applicant shall
16
submit notification to the abbreviated new drug
17
application confirming that such applicant has
18
commenced commercial marketing of the drug
19
not later than one business day after com-
20
mencing such marketing.’’.
21
(c) APPLICABILITY.—The amendments made by sub-
22
sections (a) and (b) shall apply only with respect to an
23
application filed under section 505(j) of the Federal Food,
24
Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date
25
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•S 1114 RS
of enactment of this Act that identifies a listed drug for
1
which no certification under paragraph (2)(A)(vii)(IV) of
2
such section 505(j) was made before such date of enact-
3
ment.
4
SECTION 1. SHORT TITLE.
5
This Act may be cited as the ‘‘Expanding Access to
6
Low-Cost Generics Act of 2023’’.
7
SEC. 2. 180-DAY EXCLUSIVITY PERIOD.
8
(a) IN GENERAL.—Section 505(j)(5)(B)(iv) of the Fed-
9
eral
Food,
Drug,
and
Cosmetic
Act
(21
U.S.C.
10
355(j)(5)(B)(iv)) is amended—
11
(1) in subclause (I)—
12
(A) by inserting ‘‘and subclause (III)’’ after
13
‘‘subparagraph (D)’’; and
14
(B) by inserting before the period at the end
15
the following: ‘‘or an applicant whose applica-
16
tion was approved pursuant to subclause (III).
17
If an applicant described in subclause (III) is el-
18
igible for effective approval on the same day a
19
tentatively approved first applicant who has re-
20
quested final approval is determined by the Sec-
21
retary to be eligible for effective approval by
22
meeting all the approval requirements of this
23
subsection, such applicant described in subclause
24
(III) shall not receive effective approval until
25
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•S 1114 RS
180 days after the first applicant begins com-
1
mercial marketing of the drug.’’; and
2
(2) by adding at the end the following new sub-
3
clause:
4
‘‘(III) APPLICANT
APPROVAL.—The Sec-
5
retary may approve an application containing a
6
certification
described
in
paragraph
7
(2)(A)(vii)(IV) that is for a drug for which a
8
first applicant has submitted an application
9
containing such a certification, notwithstanding
10
the eligibility of a first applicant for the 180-day
11
exclusivity
period
described
in
subclause
12
(II)(aa), if each of the following conditions is
13
met:
14
‘‘(aa) The approval of such application
15
could be made effective, but for the eligibility of
16
a first applicant for 180-day exclusivity under
17
this clause.
18
‘‘(bb) The applicant of such application has
19
submitted a certification to its abbreviated new
20
drug application that there are no conditions
21
that would prevent the applicant from commer-
22
cial marketing within 75 days after the date of
23
approval and that the applicant intends to so
24
market the drug.
25
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•S 1114 RS
‘‘(cc) At least 33 months have passed since
1
the date of submission of an application for the
2
drug by at least one first applicant.
3
‘‘(dd) Approval of an application for the
4
drug submitted by at least one first applicant is
5
not precluded under clause (iii).
6
‘‘(ee) No application for the drug submitted
7
by any first applicant is effectively approved on
8
the date that the conditions under items (aa),
9
(bb), (cc), and (dd) are all met and main-
10
tained.’’.
11
(b) SPECIAL APPROVAL STATUS RULE FOR CERTAIN
12
SUBSEQUENT APPLICANTS.—Section 505(j)(5)(D) of the
13
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
14
355(j)(5)(D)) is amended at the end by adding the fol-
15
lowing:
16
‘‘(v) SPECIAL APPROVAL STATUS RULE
17
FOR CERTAIN SUBSEQUENT APPLICANTS.—
18
An application that is approved pursuant
19
to subclause (III) of subparagraph (B)(iv)
20
is deemed to be tentatively approved and to
21
no longer have an effective approval pursu-
22
ant to such subclause (III) on the date that
23
is 76 days after the date on which the ap-
24
proval has been made effective pursuant to
25
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•S 1114 RS
such subclause (III) if the applicant fails to
1
commercially market such drug within the
2
75-day period after the date on which the
3
approval is made effective. If the applicant
4
of an application approved pursuant to
5
such subclause (III) submits a notification
6
that it can no longer commence commercial
7
marketing within 75 days after the date of
8
approval, as required under subparagraph
9
(B)(iv)(III)(bb), its application is deemed
10
to be tentatively approved and to no longer
11
be effectively approved on the date that such
12
a notification is received. If an applicant
13
does not commence commercial marketing
14
within the 75-day period, it shall not be eli-
15
gible for a subsequent effective approval for
16
the application under subclause (III) of sub-
17
paragraph (B)(iv) unless, in addition to
18
meeting each of the conditions in such sub-
19
clause (III), it submits a certification to its
20
abbreviated new drug application that an
21
event that could not have been reasonably
22
foreseen by the applicant prevented it from
23
commencing commercial marketing and
24
that it has fully resolved this issue. The ap-
25
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•S 1114 RS
plicant shall submit notification to the ab-
1
breviated new drug application confirming
2
that such applicant has commenced com-
3
mercial marketing of the drug not later
4
than one business day after commencing
5
such marketing.’’.
6
(c) APPLICABILITY.—The amendments made by sub-
7
sections (a) and (b) shall apply only with respect to an
8
application filed under section 505(j) of the Federal Food,
9
Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date
10
of enactment of this Act that identifies a listed drug for
11
which no certification under paragraph (2)(A)(vii)(IV) of
12
such section 505(j) was made before such date of enactment.
13
SEC. 3. INCREASING TRANSPARENCY IN GENERIC DRUG AP-
14
PLICATIONS.
15
(a) IN GENERAL.—Section 505(j)(3) of the Federal
16
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is
17
amended by adding at the end the following:
18
‘‘(H)(i) Upon request (in controlled correspondence or
19
an analogous process) by a person that has submitted or
20
intends to submit an abbreviated application under this
21
subsection for a drug that is required by regulation to con-
22
tain one or more of the same inactive ingredients in the
23
same concentration as the listed drug referred to, or for
24
which the Secretary determines there is a scientific jus-
25
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•S 1114 RS
tification for an approach that is in vitro, in whole or in
1
part, to be used to demonstrate bioequivalence for a drug
2
if such a drug contains one or more of the same inactive
3
ingredients in the same concentration as the listed drug re-
4
ferred to, or on the Secretary’s own initiative during the
5
review of an application under this subsection for such a
6
drug, the Secretary shall inform the person whether such
7
drug is qualitatively and quantitatively the same as the
8
listed drug.
9
‘‘(ii) Notwithstanding section 301(j), if the Secretary
10
determines that such drug is not qualitatively or quan-
11
titatively the same as the listed drug, the Secretary shall
12
identify and disclose to the person—
13
‘‘(I) the ingredient or ingredients that cause the
14
drug not to be qualitatively or quantitatively the
15
same as the listed drug; and
16
‘‘(II) for any ingredient for which there is an
17
identified quantitative deviation, the amount of such
18
deviation.
19
‘‘(iii) If the Secretary determines that such drug is
20
qualitatively and quantitatively the same as the listed drug,
21
the Secretary shall not change or rescind such determina-
22
tion after the submission of an abbreviated application for
23
such drug under this subsection unless—
24
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•S 1114 RS
‘‘(I) the formulation of the listed drug has been
1
changed and the Secretary has determined that the
2
prior listed drug formulation was withdrawn for rea-
3
sons of safety or effectiveness; or
4
‘‘(II) the Secretary makes a written determina-
5
tion that the prior determination must be changed be-
6
cause an error has been identified.
7
‘‘(iv) If the Secretary makes a written determination
8
described in clause (iii)(II), the Secretary shall provi
[Text truncated for display. Full text available on Congress.gov.]