II 

116TH CONGRESS 

1ST SESSION S. 844 

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 14, 2019 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Short on Competition 

5 Act’’. 


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1 SEC. 2. TEMPORARY IMPORTATION OF PRESCRIPTION 

2 DRUGS. 

3 (a) TEMPORARY IMPORTATION.—Section 506C of the 

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) 

5 is amended— 

6 (1) by redesignating subsections (h) and (i) as 

7 subsections (i) and (j), respectively; and 

8 (2) by inserting after subsection (g) the fol9 lowing: 

10 ‘‘(h) TEMPORARY IMPORTATION AUTHORITY.— 

11 ‘‘(1) IN GENERAL.—If, based on notifications 

12 described in subsection (a) or any other relevant in13 formation, the Secretary concludes that there is, or 

14 is likely to be, a drug shortage of a drug described 

15 in subsection (a), except as provided in paragraph 

16 (3), the Secretary shall authorize importation of 

17 such drug for a period of up to 3 years if— 

18 ‘‘(A) the drug is a drug subject to section 

19 503(b)(1), including a combination product 

20 whose primary mode of action is that of a drug 

21 as determined under section 503(g)(1)(D)(i), 

22 other than a drug described in subparagraphs 

23 (A) through (F) of section 804(a)(3); 

24 ‘‘(B) the drug is authorized to be lawfully 

25 marketed in one or more of the countries in26 cluded in the list under section 802(b)(1); 


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1 ‘‘(C) the imported drug has the same ac2 tive ingredient as the drug for which there is a 

3 shortage with respect to manufacturers in the 

4 United States; 

5 ‘‘(D) the manufacturer certifies to the Sec6 retary that it intends to seek approval of the 

7 drug under section 505(j); and 

8 ‘‘(E) an importer (as defined in section 

9 804(a)) files with the Secretary information— 

10 ‘‘(i) attesting that the requirements 

11 under subparagraphs (A) through (D) are 

12 satisfied; 

13 ‘‘(ii) identifying the drug the importer 

14 proposes to import and the manufacturer 

15 from whom the importer proposes to im16 port such drug; and 

17 ‘‘(iii) requesting authority to import 

18 the drug. 

19 ‘‘(2) BEGINNING DATE OF IMPORTATION.—Ex20 cept as provided in paragraph (3), if all of the condi21 tions under paragraph (1) are met, the Secretary 

22 shall authorize importation of a drug in accordance 

23 with such paragraph beginning not later than 60 

24 days after receipt of the information under para25 graph (1)(E). 


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1 ‘‘(3) DISCRETIONARY DENIAL OF IMPORTA2 TION.—The Secretary may deny importation of a 

3 drug otherwise qualified for importation under para4 graph (1) if the Secretary determines that— 

5 ‘‘(A) the drug is not safe and effective; 

6 ‘‘(B) the drug is used in conjunction with 

7 a device for which there is no reasonable assur8 ance of safety and effectiveness; or 

9 ‘‘(C) the authorization to market the drug 

10 in one or more of the countries included in the 

11 list under section 802(b)(1) has been rescinded 

12 or withdrawn because of any concern relating to 

13 the safety or effectiveness of the drug. 

14 ‘‘(4) TERMINATION OF AUTHORITY.—The au15 thority to import a drug pursuant to paragraph (1) 

16 shall terminate after 3 years, or when the drug 

17 shortage no longer applies, whichever occurs first.’’. 

18 (b) MARGINALLY COMPETITIVE DRUG MARKETS.— 

19 Chapter V of the Federal Food, Drug, and Cosmetic Act 

20 (21 U.S.C. 351 et seq.) is amended by inserting after sec21 tion 506C–1 the following: 

22 ‘‘SEC. 506C–2. MARGINALLY COMPETITIVE DRUG MARKETS. 

23 ‘‘(a) IN GENERAL.—If the Secretary determines 

24 under subsection (b) that a marginally competitive market 

25 exists with respect to an applicable drug, the Secretary— 


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1 ‘‘(1) shall treat such marginally competitive 

2 market as creating a drug shortage only for pur3 poses of subsections (g) and (h) of section 506C; 

4 and 

5 ‘‘(2)(A) may expedite the review of applications 

6 and inspections with respect to the drug in accord7 ance with section 506C(g); and 

8 ‘‘(B) shall authorize importation of the drug in 

9 accordance with section 506C(h). 

10 ‘‘(b) DETERMINATION OF MARGINALLY COMPETI11 TIVE MARKET.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall deter13 mine that a marginally competitive market exists 

14 with respect to an applicable drug if— 

15 ‘‘(A) for at least 2 consecutive months 

16 prior to the determination, fewer than 5 drugs 

17 approved under section 505(c) (referred to in 

18 this paragraph as the ‘applicable listed drug’) 

19 or under section 505(j) that reference the appli20 cable listed drug were commercially available in 

21 the United States; 

22 ‘‘(B) the applicable listed drug was ap23 proved at least 10 years before such determina24 tion; and 


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1 ‘‘(C) each patent which claims an active in2 gredient of the applicable listed drug has ex3 pired. 

4 ‘‘(2) COMMERCIALLY AVAILABLE.— 

5 ‘‘(A) IN GENERAL.—For purposes of para6 graph (1)(A), a drug is not commercially avail7 able in the United States if— 

8 ‘‘(i) the holder of an application ap9 proved under subsection (c) or (j) of sec10 tion 505 has publicly announced that it 

11 has discontinued the manufacturing of the 

12 drug; 

13 ‘‘(ii) a drug approved under sub14 section (c) or (j) of section 505 has been 

15 withdrawn or discontinued; or 

16 ‘‘(iii) the Secretary has any other rea17 sonable basis to conclude that a drug ap18 proved under subsection (c) or (j) of sec19 tion 505 is not competitively relevant. 

20 ‘‘(B) HOLDER OF APPROVED APPLICA21 TION.—In determining whether 5 drugs are 

22 commercially available under paragraph (1)(A), 

23 in the case of a single person who is the holder 

24 of more than one application approved as de25 scribed in paragraph (1)(A) with respect to an 


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1 applicable drug, only one such drug shall be 

2 considered to be commercially available. 

3 ‘‘(c) APPLICABLE DRUG.—In this section, the term 

4 ‘applicable drug’ means a drug that is not a radio pharma5 ceutical drug product or any other product as designated 

6 by the Secretary.’’. 

7 (c) ANNUAL REPORTING ON DRUG SHORTAGES.— 

8 Section 506C–1(a)(3)(B) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 356c–1(a)(3)(B)) is amended— 

10 (1) in clause (i), by striking ‘‘; and’’ and insert11 ing ‘‘;’’; 

12 (2) in clause (ii), by adding ‘‘and’’ after the 

13 semicolon; and 

14 (3) by inserting after clause (ii) the following: 

15 ‘‘(iii) the number of drugs authorized for 

16 temporary importation under section 506C(h);’’. 

Æ 


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