Bill Summary
The "Short on Competition Act" is proposed legislation aimed at addressing drug shortages and promoting competition in the pharmaceutical market. Key components of the bill include:
1. **Expedited Approval of Generic Drugs**: The bill allows for faster review and inspection processes for generic drugs in markets deemed "marginally competitive." This is intended to encourage the introduction of new generic options when competition is low.
2. **Temporary Importation of Prescription Drugs**: The bill grants the Secretary of Health and Human Services the authority to authorize the temporary importation of prescription drugs for up to three years if there is a shortage of a specific drug. This provision applies to drugs that are already legally marketed in other countries and are equivalent to the drugs in shortage in the U.S.
3. **Criteria for Marginally Competitive Markets**: The Secretary can determine that a market is marginally competitive if fewer than five approved drugs are commercially available for at least two consecutive months. This determination is crucial for invoking expedited review and importation processes.
4. **Annual Reporting**: The bill requires annual reporting on drug shortages, including specific data on drugs authorized for temporary importation, to enhance transparency and oversight.
Overall, the "Short on Competition Act" aims to improve access to essential medications during shortages and foster a more competitive pharmaceutical landscape.
Possible Impacts
Here are three examples of how the "Short on Competition Act" could affect people:
1. **Increased Access to Medications**: By allowing for the expedited approval of generic prescription drugs and the temporary importation of prescription drugs during shortages, patients may experience improved access to necessary medications. This is particularly important in cases where there are limited treatment options available due to market competition constraints or shortages, ensuring that individuals can obtain the drugs they need in a timely manner.
2. **Cost Savings**: The legislation aims to boost competition in drug markets. As more generic alternatives become available and imported drugs can fill gaps during shortages, patients could benefit from lower prices for medications. This could reduce the financial burden on individuals who rely on expensive prescription drugs, making healthcare more affordable.
3. **Safety and Quality Concerns**: While the act facilitates the importation of drugs and the approval of generics, there may be concerns about the safety and quality of imported medications. If a drug is imported from a country where regulatory standards differ from those in the U.S., patients might worry about the effectiveness and safety of those medications. Regulatory oversight will be crucial to ensure that imported drugs meet safety standards and do not pose a risk to public health.
[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);''.
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