No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2345 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 2345
To allow for expedited approval of generic prescription drugs and
temporary importation of prescription drugs in the case of marginally
competitive drug markets and drug shortages.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 17, 2025
Ms. Klobuchar (for herself, Mr. Lee, Mr. Durbin, and Mr. Grassley)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To allow for expedited approval of generic prescription drugs and
temporary importation of prescription drugs in the case of marginally
competitive drug markets and drug shortages.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Short on Competition Act''.
SEC. 2. TEMPORARY IMPORTATION OF PRESCRIPTION DRUGS.
(a) Temporary Importation.--Section 506C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356c) is amended--
(1) by redesignating subsections (h), (i), and (j) as
subsections (i), (j), and (k) respectively; and
(2) by inserting after subsection (g) the following:
``(h) Temporary Importation Authority.--
``(1) In general.--If, based on notifications described in
subsection (a) or any other relevant information, the Secretary
concludes that there is, or is likely to be, a drug shortage of
a drug described in subsection (a), except as provided in
paragraph (3), the Secretary shall authorize importation of
such drug for a period of up to 3 years if--
``(A) the drug is a drug subject to section
503(b)(1), including a combination product whose
primary mode of action is that of a drug as determined
under section 503(g)(1)(D)(i), other than a drug
described in subparagraphs (A) through (F) of section
804(a)(3);
``(B) the drug is authorized to be lawfully
marketed in one or more of the countries included in
the list under section 802(b)(1);
``(C) the imported drug has the same active
ingredient as the drug for which there is a shortage
with respect to manufacturers in the United States;
``(D) the manufacturer certifies to the Secretary
that it intends to seek approval of the drug under
section 505(j); and
``(E) an importer (as defined in section 804(a))
files with the Secretary information--
``(i) attesting that the requirements under
subparagraphs (A) through (D) are satisfied;
``(ii) identifying the drug the importer
proposes to import and the manufacturer from
whom the importer proposes to import such drug;
and
``(iii) requesting authority to import the
drug.
``(2) Beginning date of importation.--Except as provided in
paragraph (3), if all of the conditions under paragraph (1) are
met, the Secretary shall authorize importation of a drug in
accordance with such paragraph beginning not later than 60 days
after receipt of the information under paragraph (1)(E).
``(3) Discretionary denial of importation.--The Secretary
may deny importation of a drug otherwise qualified for
importation under paragraph (1) if the Secretary determines
that--
``(A) the drug is not safe and effective;
``(B) the drug is used in conjunction with a device
for which there is no reasonable assurance of safety
and effectiveness; or
``(C) the authorization to market the drug in one
or more of the countries included in the list under
section 802(b)(1) has been rescinded or withdrawn
because of any concern relating to the safety or
effectiveness of the drug.
``(4) Termination of authority.--The authority to import a
drug pursuant to paragraph (1) shall terminate after 3 years,
or when the drug shortage no longer applies, whichever occurs
first.''.
(b) Marginally Competitive Drug Markets.--Chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 506C-1 the following:
``SEC. 506C-2. MARGINALLY COMPETITIVE DRUG MARKETS.
``(a) In General.--If the Secretary determines under subsection (b)
that a marginally competitive market exists with respect to an
applicable drug, the Secretary--
``(1) shall treat such marginally competitive market as
creating a drug shortage only for purposes of subsections (g)
and (h) of section 506C; and
``(2)(A) may expedite the review of applications and
inspections with respect to the drug in accordance with section
506C(g); and
``(B) shall authorize importation of the drug in accordance
with section 506C(h).
``(b) Determination of Marginally Competitive Market.--
``(1) In general.--The Secretary shall determine that a
marginally competitive market exists with respect to an
applicable drug if--
``(A) for at least 2 consecutive months prior to
the determination, fewer than 5 drugs approved under
section 505(c) (referred to in this paragraph as the
`applicable listed drug') or under section 505(j) that
reference the applicable listed drug were commercially
available in the United States;
``(B) the applicable listed drug was approved at
least 10 years before such determination; and
``(C) each patent which claims an active ingredient
of the applicable listed drug has expired.
``(2) Commercially available.--
``(A) In general.--For purposes of paragraph
(1)(A), a drug is not commercially available in the
United States if--
``(i) the holder of an application approved
under subsection (c) or (j) of section 505 has
publicly announced that it has discontinued the
manufacturing of the drug;
``(ii) a drug approved under subsection (c)
or (j) of section 505 has been withdrawn or
discontinued; or
``(iii) the Secretary has any other
reasonable basis to conclude that a drug
approved under subsection (c) or (j) of section
505 is not competitively relevant.
``(B) Holder of approved application.--In
determining whether 5 drugs are commercially available
under paragraph (1)(A), in the case of a single person
who is the holder of more than one application approved
as described in paragraph (1)(A) with respect to an
applicable drug, only one such drug shall be considered
to be commercially available.
``(c) Applicable Drug.--In this section, the term `applicable drug'
means a drug that is not a radio pharmaceutical drug product or any
other product as designated by the Secretary.''.
(c) Annual Reporting on Drug Shortages.--Section 506C-1(a)(5)(B) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(5)(B)) is
amended--
(1) in clause (i), by striking ``; and'' and inserting
``;'';
(2) in clause (ii), by adding ``and'' after the semicolon;
and
(3) by inserting after clause (ii) the following:
``(iii) the number of drugs authorized for
temporary importation under section 506C(h);''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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