II 

114TH CONGRESS 

2D SESSION S. 3455 

To allow for expedited approval of generic prescription drugs and temporary 

importation of prescription drugs in the case of noncompetitive drug 

markets and drug shortages. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 28, 2016 

Ms. KLOBUCHAR (for herself and Mr. LEE) 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 noncompetitive 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 ‘‘Pharmaceutical Supply 

5 and Value Enhancement Act’’ or the ‘‘Pharmaceutical 

6 SAVE 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), other than a drug described in sub20 paragraphs (A) through (F) of section 

21 804(a)(3); 

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

23 marketed in one or more of the countries in24 cluded in the list under section 802(b)(1); 

25 ‘‘(C) the imported drug has the same ac26 tive ingredient as the drug for which there is a 


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1 shortage described in subsection (i)(2)(B) with 

2 respect to manufacturers in the United States; 

3 ‘‘(D) the manufacturer certifies to the Sec4 retary that it intends to seek approval of the 

5 drug under section 505(j); and 

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

7 804(a)) files with the Secretary information— 

8 ‘‘(i) attesting that the requirements 

9 under subparagraphs (A) through (D) are 

10 satisfied; 

11 ‘‘(ii) identifying the drug the importer 

12 proposes to import and the manufacturer 

13 from whom the importer proposes to im14 port such drug; and 

15 ‘‘(iii) requesting authority to import 

16 the drug. 

17 ‘‘(2) BEGINNING DATE OF IMPORTATION.—If 

18 all of the conditions under paragraph (1) are met, 

19 the Secretary shall authorize importation of a drug 

20 in accordance with such paragraph beginning not 

21 later than 60 days after receipt of the information 

22 under paragraph (1)(E). 

23 ‘‘(3) DISCRETIONARY DENIAL OF IMPORTA24 TION.—The Secretary may deny importation of a 


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1 drug otherwise qualified for importation under para2 graph (1) if the Secretary determines that— 

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

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

5 a device for which there is no reasonable assur6 ance of safety and effectiveness; or 

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

8 in one or more of the countries included in the 

9 list under section 802(b)(1) has been rescinded 

10 or withdrawn because of any concern relating to 

11 the safety or effectiveness of the drug. 

12 ‘‘(4) TERMINATION OF AUTHORITY.—The au13 thority to import a drug pursuant to paragraph (1) 

14 shall terminate after 3 years, or when the drug 

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

16 (b) NONCOMPETITIVE DRUG MARKETS.—Chapter V 

17 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 351 et seq.) is amended by inserting after section 506C– 

19 1 the following: 

20 ‘‘SEC. 506C–2. NONCOMPETITIVE DRUG MARKETS. 

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

22 under subsection (b) that a noncompetitive market exists 

23 with respect to an applicable drug, the Secretary— 

24 ‘‘(1) shall treat such noncompetitive market as 

25 creating a drug shortage for purposes of section 


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1 506C(g), and may expedite the review of applica2 tions and inspections in accordance with such sub3 section; and 

4 ‘‘(2) shall treat such noncompetitive market as 

5 creating a drug shortage for purposes of section 

6 506C(h), and shall authorize importation of the drug 

7 in accordance with such subsection. 

8 ‘‘(b) DETERMINATION OF NONCOMPETITIVE MAR9 KET.— 

10 ‘‘(1) IN GENERAL.—The Secretary shall deter11 mine that a noncompetitive market exists with re12 spect to an applicable drug if— 

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

14 prior to the determination, fewer than 5 drugs 

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

16 this paragraph as the ‘applicable listed drug’) 

17 or under section 505(j) that reference the appli18 cable listed drug were commercially available in 

19 the United States; 

20 ‘‘(B) the applicable listed drug was ap21 proved at least 10 years before such determina22 tion; and 

23 ‘‘(C) each patent which claims an active in24 gredient of the applicable listed drug has ex25 pired. 


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1 ‘‘(2) COMMERCIALLY AVAILABLE.— 

2 ‘‘(A) IN GENERAL.—For purposes of para3 graph (1)(A), a drug is not commercially avail4 able in the United States if— 

5 ‘‘(i) the holder of an application ap6 proved under subsection (c) or (j) of sec7 tion 505 has publicly announced that it 

8 has discontinued the manufacturing of the 

9 drug; 

10 ‘‘(ii) a drug approved under sub11 section (c) or (j) of section 505 has been 

12 withdrawn or discontinued; or 

13 ‘‘(iii) the Secretary has any other rea14 sonable basis to conclude that a drug ap15 proved under subsection (c) or (j) of sec16 tion 505 is not competitively relevant. 

17 ‘‘(B) HOLDER OF APPROVED APPLICA18 TION.—In determining whether 5 drugs are 

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

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

21 of more than 1 application approved as de22 scribed in paragraph (1)(A) with respect to an 

23 applicable drug, only 1 such drug shall be con24 sidered to be commercially available. 


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

2 ‘applicable drug’ means a drug that is not a radio pharma3 ceutical drug product or any other product as designated 

4 by the Secretary.’’. 

5 (c) ANNUAL REPORTING ON DRUG SHORTAGES.— 

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

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

8 (1) in clause (i), by striking ‘‘; and’’ and insert9 ing ‘‘;’’; 

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

11 semicolon; and 

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

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

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

Æ 


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