What This Bill Does
This bill allows the federal government to speed up approval of generic prescription drugs and bring in drugs from other countries during drug shortages. It also creates rules for when markets have too few drug options available to Americans.
Who It Affects
The federal Food and Drug Administration (the agency that approves drugs), drug manufacturers, drug importers (businesses that bring drugs into the country), and patients who need prescription medications.
Key Provisions
• The FDA can allow drugs to be brought into the United States for up to 3 years if there is a drug shortage, the drug is approved in certain other countries, and a manufacturer plans to seek FDA approval for it (Sec. 2(a), subsection (h)(1)).
• The FDA must decide whether to allow importation within 60 days of receiving the proper paperwork (Sec. 2(a), subsection (h)(2)).
• The FDA can refuse to allow importation if the drug is not safe and effective, or if it was taken off the market in another country because of safety or effectiveness concerns (Sec. 2(a), subsection (h)(3)).
• When a market has fewer than 5 competing drugs available for at least 2 consecutive months, the FDA can speed up its review process and allow temporary drug importation (Sec. 2(b), subsection (a)).
• The FDA must report each year how many drugs were authorized for temporary importation (Sec. 2(c)).
What Changes
The bill adds new sections to federal drug law that did not exist before. It creates a legal pathway for temporary drug importation during shortages and defines when a drug market is considered "marginally competitive" (meaning it has very few options). The FDA gains authority it did not have before to approve these temporary imports within specific timeframes.
Important Definitions
• "Applicable drug": A prescription drug that is not a radiopharmaceutical (a drug containing radioactive material) or other products the FDA designates (Sec. 2(b), subsection (c)).
• "Marginally competitive market": A situation where fewer than 5 competing drugs approved by the FDA are actually available for sale in the United States for at least 2 months in a row (Sec. 2(b), subsection (b)(1)(A)).
• "Commercially available": A drug is not considered commercially available if the manufacturer announced it stopped making it, the drug was withdrawn from the market, or the FDA has reason to believe it is not actively competing (Sec. 2(b), subsection (b)(2)(A)).
II
118TH CONGRESS
1ST SESSION
S. 845
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
MARCH 16, 2023
Ms. KLOBUCHAR (for herself, Mr. LEE, Mr. DURBIN, and Mr. GRASSLEY) in-
troduced the following bill; which was read twice and referred to the Com-
mittee 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 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 ‘‘Short on Competition
4
Act’’.
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•S 845 IS
SEC. 2. TEMPORARY IMPORTATION OF PRESCRIPTION
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DRUGS.
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(a) TEMPORARY IMPORTATION.—Section 506C of the
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c)
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is amended—
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(1) by redesignating subsections (h), (i), and (j)
6
as subsections (i), (j), and (k) respectively; and
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(2) by inserting after subsection (g) the fol-
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lowing:
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‘‘(h) TEMPORARY IMPORTATION AUTHORITY.—
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‘‘(1) IN GENERAL.—If, based on notifications
11
described in subsection (a) or any other relevant in-
12
formation, the Secretary concludes that there is, or
13
is likely to be, a drug shortage of a drug described
14
in subsection (a), except as provided in paragraph
15
(3), the Secretary shall authorize importation of
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such drug for a period of up to 3 years if—
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‘‘(A) the drug is a drug subject to section
18
503(b)(1), including a combination product
19
whose primary mode of action is that of a drug
20
as determined under section 503(g)(1)(D)(i),
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other than a drug described in subparagraphs
22
(A) through (F) of section 804(a)(3);
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‘‘(B) the drug is authorized to be lawfully
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marketed in one or more of the countries in-
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cluded in the list under section 802(b)(1);
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‘‘(C) the imported drug has the same ac-
1
tive ingredient as the drug for which there is a
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shortage with respect to manufacturers in the
3
United States;
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‘‘(D) the manufacturer certifies to the Sec-
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retary that it intends to seek approval of the
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drug under section 505(j); and
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‘‘(E) an importer (as defined in section
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804(a)) files with the Secretary information—
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‘‘(i) attesting that the requirements
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under subparagraphs (A) through (D) are
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satisfied;
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‘‘(ii) identifying the drug the importer
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proposes to import and the manufacturer
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from whom the importer proposes to im-
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port such drug; and
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‘‘(iii) requesting authority to import
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the drug.
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‘‘(2) BEGINNING DATE OF IMPORTATION.—Ex-
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cept as provided in paragraph (3), if all of the condi-
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tions under paragraph (1) are met, the Secretary
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shall authorize importation of a drug in accordance
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with such paragraph beginning not later than 60
23
days after receipt of the information under para-
24
graph (1)(E).
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‘‘(3) DISCRETIONARY
DENIAL
OF
IMPORTA-
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TION.—The Secretary may deny importation of a
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drug otherwise qualified for importation under para-
3
graph (1) if the Secretary determines that—
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‘‘(A) the drug is not safe and effective;
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‘‘(B) the drug is used in conjunction with
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a device for which there is no reasonable assur-
7
ance of safety and effectiveness; or
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‘‘(C) the authorization to market the drug
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in one or more of the countries included in the
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list under section 802(b)(1) has been rescinded
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or withdrawn because of any concern relating to
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the safety or effectiveness of the drug.
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‘‘(4) TERMINATION OF AUTHORITY.—The au-
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thority to import a drug pursuant to paragraph (1)
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shall terminate after 3 years, or when the drug
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shortage no longer applies, whichever occurs first.’’.
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(b) MARGINALLY COMPETITIVE DRUG MARKETS.—
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Chapter V of the Federal Food, Drug, and Cosmetic Act
19
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
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tion 506C–1 the following:
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‘‘SEC. 506C–2. MARGINALLY COMPETITIVE DRUG MARKETS.
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‘‘(a) IN GENERAL.—If the Secretary determines
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under subsection (b) that a marginally competitive market
24
exists with respect to an applicable drug, the Secretary—
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‘‘(1) shall treat such marginally competitive
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market as creating a drug shortage only for pur-
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poses of subsections (g) and (h) of section 506C;
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and
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‘‘(2)(A) may expedite the review of applications
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and inspections with respect to the drug in accord-
6
ance with section 506C(g); and
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‘‘(B) shall authorize importation of the drug in
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accordance with section 506C(h).
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‘‘(b) DETERMINATION
OF MARGINALLY COMPETI-
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TIVE MARKET.—
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‘‘(1) IN GENERAL.—The Secretary shall deter-
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mine that a marginally competitive market exists
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with respect to an applicable drug if—
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‘‘(A) for at least 2 consecutive months
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prior to the determination, fewer than 5 drugs
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approved under section 505(c) (referred to in
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this paragraph as the ‘applicable listed drug’)
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or under section 505(j) that reference the appli-
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cable listed drug were commercially available in
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the United States;
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‘‘(B) the applicable listed drug was ap-
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proved at least 10 years before such determina-
23
tion; and
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‘‘(C) each patent which claims an active in-
1
gredient of the applicable listed drug has ex-
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pired.
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‘‘(2) COMMERCIALLY AVAILABLE.—
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‘‘(A) IN GENERAL.—For purposes of para-
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graph (1)(A), a drug is not commercially avail-
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able in the United States if—
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‘‘(i) the holder of an application ap-
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proved under subsection (c) or (j) of sec-
9
tion 505 has publicly announced that it
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has discontinued the manufacturing of the
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drug;
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‘‘(ii) a drug approved under sub-
13
section (c) or (j) of section 505 has been
14
withdrawn or discontinued; or
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‘‘(iii) the Secretary has any other rea-
16
sonable basis to conclude that a drug ap-
17
proved under subsection (c) or (j) of sec-
18
tion 505 is not competitively relevant.
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‘‘(B) HOLDER
OF
APPROVED
APPLICA-
20
TION.—In determining whether 5 drugs are
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commercially available under paragraph (1)(A),
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in the case of a single person who is the holder
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of more than one application approved as de-
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scribed in paragraph (1)(A) with respect to an
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•S 845 IS
applicable drug, only one such drug shall be
1
considered to be commercially available.
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‘‘(c) APPLICABLE DRUG.—In this section, the term
3
‘applicable drug’ means a drug that is not a radio pharma-
4
ceutical drug product or any other product as designated
5
by the Secretary.’’.
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(c) ANNUAL REPORTING ON DRUG SHORTAGES.—
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Section 506C–1(a)(5)(B) of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 356c–1(a)(5)(B)) is amended—
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(1) in clause (i), by striking ‘‘; and’’ and insert-
10
ing ‘‘;’’;
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(2) in clause (ii), by adding ‘‘and’’ after the
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semicolon; and
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(3) by inserting after clause (ii) the following:
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‘‘(iii) the number of drugs authorized for
15
temporary importation under section 506C(h);’’.
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Æ
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