Short on Competition Act

II 117TH CONGRESS 1ST SESSION S. 917 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 23, 2021 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’’. 5 VerDate Sep 11 2014 01:05 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S917.IS S917 kjohnson on DSK79L0C42PROD with BILLS 2 •S 917 IS SEC. 2. TEMPORARY IMPORTATION OF PRESCRIPTION 1 DRUGS. 2 (a) TEMPORARY IMPORTATION.—Section 506C of the 3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) 4 is amended— 5 (1) by redesignating subsections (h), (i), and (j) 6 as subsections (i), (j), and (k) respectively; and 7 (2) by inserting after subsection (g) the fol- 8 lowing: 9 ‘‘(h) TEMPORARY IMPORTATION AUTHORITY.— 10 ‘‘(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 16 such drug for a period of up to 3 years if— 17 ‘‘(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), 21 other than a drug described in subparagraphs 22 (A) through (F) of section 804(a)(3); 23 ‘‘(B) the drug is authorized to be lawfully 24 marketed in one or more of the countries in- 25 cluded in the list under section 802(b)(1); 26 VerDate Sep 11 2014 01:05 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S917.IS S917 kjohnson on DSK79L0C42PROD with BILLS 3 •S 917 IS ‘‘(C) the imported drug has the same ac- 1 tive ingredient as the drug for which there is a 2 shortage with respect to manufacturers in the 3 United States; 4 ‘‘(D) the manufacturer certifies to the Sec- 5 retary that it intends to seek approval of the 6 drug under section 505(j); and 7 ‘‘(E) an importer (as defined in section 8 804(a)) files with the Secretary information— 9 ‘‘(i) attesting that the requirements 10 under subparagraphs (A) through (D) are 11 satisfied; 12 ‘‘(ii) identifying the drug the importer 13 proposes to import and the manufacturer 14 from whom the importer proposes to im- 15 port such drug; and 16 ‘‘(iii) requesting authority to import 17 the drug. 18 ‘‘(2) BEGINNING DATE OF IMPORTATION.—Ex- 19 cept as provided in paragraph (3), if all of the condi- 20 tions under paragraph (1) are met, the Secretary 21 shall authorize importation of a drug in accordance 22 with such paragraph beginning not later than 60 23 days after receipt of the information under para- 24 graph (1)(E). 25 VerDate Sep 11 2014 01:05 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S917.IS S917 kjohnson on DSK79L0C42PROD with BILLS 4 •S 917 IS ‘‘(3) DISCRETIONARY DENIAL OF IMPORTA- 1 TION.—The Secretary may deny importation of a 2 drug otherwise qualified for importation under para- 3 graph (1) if the Secretary determines that— 4 ‘‘(A) the drug is not safe and effective; 5 ‘‘(B) the drug is used in conjunction with 6 a device for which there is no reasonable assur- 7 ance of safety and effectiveness; or 8 ‘‘(C) the authorization to market the drug 9 in one or more of the countries included in the 10 list under section 802(b)(1) has been rescinded 11 or withdrawn because of any concern relating to 12 the safety or effectiveness of the drug. 13 ‘‘(4) TERMINATION OF AUTHORITY.—The au- 14 thority to import a drug pursuant to paragraph (1) 15 shall terminate after 3 years, or when the drug 16 shortage no longer applies, whichever occurs first.’’. 17 (b) MARGINALLY COMPETITIVE DRUG MARKETS.— 18 Chapter V of the Federal Food, Drug, and Cosmetic Act 19 (21 U.S.C. 351 et seq.) is amended by inserting after sec- 20 tion 506C–1 the following: 21 ‘‘SEC. 506C–2. MARGINALLY COMPETITIVE DRUG MARKETS. 22 ‘‘(a) IN GENERAL.—If the Secretary determines 23 under subsection (b) that a marginally competitive market 24 exists with respect to an applicable drug, the Secretary— 25 VerDate Sep 11 2014 01:05 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S917.IS S917 kjohnson on DSK79L0C42PROD with BILLS 5 •S 917 IS ‘‘(1) shall treat such marginally competitive 1 market as creating a drug shortage only for pur- 2 poses of subsections (g) and (h) of section 506C; 3 and 4 ‘‘(2)(A) may expedite the review of applications 5 and inspections with respect to the drug in accord- 6 ance with section 506C(g); and 7 ‘‘(B) shall authorize importation of the drug in 8 accordance with section 506C(h). 9 ‘‘(b) DETERMINATION OF MARGINALLY COMPETI- 10 TIVE MARKET.— 11 ‘‘(1) IN GENERAL.—The Secretary shall deter- 12 mine that a marginally competitive market exists 13 with respect to an applicable drug if— 14 ‘‘(A) for at least 2 consecutive months 15 prior to the determination, fewer than 5 drugs 16 approved under section 505(c) (referred to in 17 this paragraph as the ‘applicable listed drug’) 18 or under section 505(j) that reference the appli- 19 cable listed drug were commercially available in 20 the United States; 21 ‘‘(B) the applicable listed drug was ap- 22 proved at least 10 years before such determina- 23 tion; and 24 VerDate Sep 11 2014 01:05 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S917.IS S917 kjohnson on DSK79L0C42PROD with BILLS 6 •S 917 IS ‘‘(C) each patent which claims an active in- 1 gredient of the applicable listed drug has ex- 2 pired. 3 ‘‘(2) COMMERCIALLY AVAILABLE.— 4 ‘‘(A) IN GENERAL.—For purposes of para- 5 graph (1)(A), a drug is not commercially avail- 6 able in the United States if— 7 ‘‘(i) the holder of an application ap- 8 proved under subsection (c) or (j) of sec- 9 tion 505 has publicly announced that it 10 has discontinued the manufacturing of the 11 drug; 12 ‘‘(ii) a drug approved under sub- 13 section (c) or (j) of section 505 has been 14 withdrawn or discontinued; or 15 ‘‘(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. 19 ‘‘(B) HOLDER OF APPROVED APPLICA- 20 TION.—In determining whether 5 drugs are 21 commercially available under paragraph (1)(A), 22 in the case of a single person who is the holder 23 of more than one application approved as de- 24 scribed in paragraph (1)(A) with respect to an 25 VerDate Sep 11 2014 01:05 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S917.IS S917 kjohnson on DSK79L0C42PROD with BILLS 7 •S 917 IS applicable drug, only one such drug shall be 1 considered to be commercially available. 2 ‘‘(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.’’. 6 (c) ANNUAL REPORTING ON DRUG SHORTAGES.— 7 Section 506C–1(a)(3)(B) of the Federal Food, Drug, and 8 Cosmetic Act (21 U.S.C. 356c–1(a)(3)(B)) is amended— 9 (1) in clause (i), by striking ‘‘; and’’ and insert- 10 ing ‘‘;’’; 11 (2) in clause (ii), by adding ‘‘and’’ after the 12 semicolon; and 13 (3) by inserting after clause (ii) the following: 14 ‘‘(iii) the number of drugs authorized for 15 temporary importation under section 506C(h);’’. 16 Æ VerDate Sep 11 2014 01:05 Apr 13, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S917.IS S917 kjohnson on DSK79L0C42PROD with BILLS