Affordable Insulin Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 1478 To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe insulin by wholesale distributors, phar- macies, and individuals. IN THE HOUSE OF REPRESENTATIVES FEBRUARY 28, 2019 Mr. WELCH (for himself and Mr. ROONEY of Florida) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe insulin by wholesale distributors, pharmacies, and individuals. 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 ‘‘Affordable Insulin Act 4 of 2019’’. 5 SEC. 2. IMPORTING AFFORDABLE AND SAFE INSULIN. 6 (a) IN GENERAL.—The Federal Food, Drug, and 7 Cosmetic Act is amended by inserting after section 804 8 of such Act (21 U.S.C. 384) the following: 9 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 2 •HR 1478 IH ‘‘SEC. 804A. IMPORTATION OF SAFE AND AFFORDABLE IN- 1 SULIN BY WHOLESALE DISTRIBUTORS, PHAR- 2 MACIES, AND INDIVIDUALS. 3 ‘‘(a) IN GENERAL.— 4 ‘‘(1) REGULATION.—Not later than 180 days 5 after the date of enactment of this section, the Sec- 6 retary shall promulgate regulations permitting the 7 importation of qualifying insulin into the United 8 States, in accordance with this section. 9 ‘‘(2) RELATION TO SECTION 804.—Nothing in 10 section 804 shall be construed to supercede or limit 11 the provisions of this section. 12 ‘‘(b) DEFINITIONS.—For purposes of this section: 13 ‘‘(1) CERTIFIED FOREIGN SELLER.—The term 14 ‘certified foreign seller’ means a licensed foreign 15 pharmacy or foreign wholesale distributor that the 16 Secretary certifies under subsection (d)(1)(B), that 17 pays the fee required under subsection (d)(1)(C), 18 and that is included on the list described in sub- 19 section (c). 20 ‘‘(2) FOREIGN WHOLESALE DISTRIBUTOR.— 21 The term ‘foreign wholesale distributor’ means a 22 person (other than a manufacturer, a manufactur- 23 er’s co-licensed partner, a third-party logistics pro- 24 vider, or a repackager) engaged in wholesale dis- 25 tribution. 26 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 3 •HR 1478 IH ‘‘(3) IMPORTER.—The term ‘importer’ means a 1 dispenser (as defined in section 581(3)) or wholesale 2 distributor registered under section 503(e) who im- 3 ports insulin into the United States in accordance 4 with this section. 5 ‘‘(4) LICENSED FOREIGN PHARMACY.—The 6 term ‘licensed foreign pharmacy’ means a pharmacy 7 located in Canada, or subject to subsection (e), an- 8 other applicable country, that— 9 ‘‘(A) operates in accordance with applica- 10 ble pharmacy standards set forth by the provin- 11 cial pharmacy rules and regulations enacted in 12 Canada, or, subject to subsection (e), such ap- 13 plicable rules and regulations of the permitted 14 country in which such seller is located; and 15 ‘‘(B) is licensed to operate and dispense in- 16 sulin to individuals in Canada, or, subject to 17 subsection (e), the permitted country in which 18 the pharmacy is located. 19 ‘‘(5) QUALIFYING INSULIN.—The term ‘quali- 20 fying insulin’ means insulin that— 21 ‘‘(A) is approved for use in patients, and 22 marketed, in Canada, or subject to subsection 23 (e), approved for use in patients, and marketed, 24 in another permitted country; 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 4 •HR 1478 IH ‘‘(B) is manufactured in a facility reg- 1 istered under subsection (b)(1) or (i) of section 2 510 that is in compliance with good manufac- 3 turing practices regulations of the Food and 4 Drug Administration; 5 ‘‘(C) has the same active ingredient or in- 6 gredients, route of administration, and strength 7 as an insulin approved under chapter V, or is 8 biosimilar to an approved biological product and 9 has the same route of administration and 10 strength as the approved biological product; and 11 ‘‘(D) is labeled in accordance with— 12 ‘‘(i) the laws of Canada, or another 13 country from which importation is per- 14 mitted pursuant to subsection (e); and 15 ‘‘(ii) the requirements promulgated by 16 the Secretary, which shall include labeling 17 in English; 18 ‘‘(6) VALID PRESCRIPTION.—The term ‘valid 19 prescription’ means a prescription that is issued for 20 a legitimate medical purpose in the usual course of 21 professional practice by— 22 ‘‘(A) a practitioner who has conducted at 23 least 1 in-person medical evaluation of the pa- 24 tient; or 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 5 •HR 1478 IH ‘‘(B) a covering practitioner. 1 ‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL- 2 ERS.—The Secretary shall publish on a dedicated internet 3 website a list of certified foreign sellers, including the 4 internet website address, physical address, and telephone 5 number of each such certified foreign seller. 6 ‘‘(d) ADDITIONAL CRITERIA.— 7 ‘‘(1) CERTIFIED FOREIGN SELLERS.— 8 ‘‘(A) IN GENERAL.—To be a certified for- 9 eign seller, such seller shall— 10 ‘‘(i) be certified by the Secretary in 11 accordance with subparagraph (B); 12 ‘‘(ii) pay the registration fee estab- 13 lished under subparagraph (C); and 14 ‘‘(iii) sell only qualifying insulin to im- 15 porters or individuals who import insulin 16 into the United States in accordance with 17 this section. 18 ‘‘(B) CERTIFICATION.—To be a certified 19 foreign seller, the Secretary shall certify that 20 such seller— 21 ‘‘(i) is a foreign wholesale distributor 22 or licensed foreign pharmacy operating an 23 establishment, which may include an online 24 foreign pharmacy, that is located in Can- 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 6 •HR 1478 IH ada, or, subject to subsection (e), another 1 permitted country; 2 ‘‘(ii) is engaged in the distribution or 3 dispensing of an insulin that is imported or 4 offered for importation into the United 5 States; 6 ‘‘(iii) has been in existence for a pe- 7 riod of at least 5 years preceding the date 8 of such certification and has a purpose 9 other than to participate in the program 10 established under this section; 11 ‘‘(iv) in the case of a certified foreign 12 seller that is a licensed foreign pharmacy, 13 agrees to dispense qualifying insulin to an 14 individual in the United States only after 15 receiving a valid prescription, as described 16 in paragraph (2)(C); 17 ‘‘(v) has processes established by the 18 seller, or participates in another estab- 19 lished process, to certify that the physical 20 premises and data reporting procedures 21 and licenses are in compliance with all ap- 22 plicable laws and regulations of Canada, 23 or, subject to subsection (e), the permitted 24 country in which the seller is located, and 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 7 •HR 1478 IH has implemented policies designed to mon- 1 itor ongoing compliance with such laws 2 and regulations; 3 ‘‘(vi) conducts or commits to partici- 4 pate in ongoing and comprehensive quality 5 assurance programs and implements such 6 quality assurance measures, including 7 blind testing, to ensure the veracity and re- 8 liability of the findings of the quality as- 9 surance program; 10 ‘‘(vii) agrees that, pursuant to sub- 11 section (g), laboratories approved by the 12 Secretary may be authorized to conduct in- 13 sulin testing to determine the chemical au- 14 thenticity of sample insulin products; 15 ‘‘(viii) agrees to notify the Secretary, 16 importers, and individuals of insulin recalls 17 in Canada, or pursuant to subsection (e), 18 the permitted country in which the seller is 19 located, and agrees to cease, or refrain 20 from, exporting such insulin; 21 ‘‘(ix) has established, or will establish 22 or participate in, a process for resolving 23 grievances, as defined by the Secretary, 24 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 8 •HR 1478 IH and will be held accountable for violations 1 of established guidelines and rules; 2 ‘‘(x) except as otherwise permitted 3 under this section, does not sell products 4 that the seller could not otherwise legally 5 sell in Canada, or, subject to subsection 6 (e), the permitted country in which such 7 seller is located to customers in the United 8 States; and 9 ‘‘(xi) meets any other criteria estab- 10 lished by the Secretary. 11 ‘‘(C) CERTIFICATION FEE.—Not later than 12 30 days before the start of each fiscal year, the 13 Secretary shall establish a fee to be collected 14 from foreign sellers for such fiscal year that are 15 certified under subparagraph (B), in an amount 16 that is sufficient, and not more than necessary, 17 to pay the costs of administering the program 18 under this section, and enforcing this section 19 pursuant to section 303(h), for that fiscal year. 20 ‘‘(D) RECERTIFICATION.—A certification 21 under subparagraph (B) shall be in effect for a 22 period of 2 years, or until there is a material 23 change in the circumstances under which the 24 foreign seller meets the requirements under 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 9 •HR 1478 IH such subparagraph, whichever occurs earlier. A 1 foreign seller may reapply for certification 2 under such subparagraph (B), in accordance 3 with a process established by the Secretary. 4 ‘‘(2) INDIVIDUALS.—An individual may import 5 a qualifying insulin described in subsection (b) from 6 Canada or another country pursuant to subsection 7 (e) if such qualifying insulin— 8 ‘‘(A) is dispensed, including through an 9 online pharmacy, by a certified foreign seller 10 that is a licensed foreign pharmacy; 11 ‘‘(B) is purchased for personal use by the 12 individual, not for resale; and 13 ‘‘(C) is filled only after providing to the li- 14 censed foreign pharmacy a valid prescription 15 issued by a health care practitioner licensed to 16 practice in a State in the United States. 17 ‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be- 18 ginning on the date that is 2 years after the date on which 19 final regulations are promulgated to carry out this section, 20 if, based on a review of the evidence obtained after such 21 effective date, including the reports submitted under sec- 22 tion 2(d) of the Affordable Insulin Act of 2019, that im- 23 portation of qualifying insulin from Canada under this 24 section resulted in cost savings for consumers in the 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 10 •HR 1478 IH United States and increased access to safe insulin, the 1 Secretary shall have the authority to permit importation 2 of qualifying insulin by importers and individuals from, 3 in addition to Canada, any country that— 4 ‘‘(1) is a member of the Organisation for Eco- 5 nomic Co-operation and Development; and 6 ‘‘(2) has statutory or regulatory standards for 7 the approval and sale of insulin that are comparable 8 to the standards in the United States and that— 9 ‘‘(A) authorize the approval of drugs only 10 if a drug has been determined to be safe and 11 effective by experts employed by or acting on 12 behalf of a governmental entity and qualified by 13 scientific training and experience to evaluate 14 the safety and effectiveness of drugs; 15 ‘‘(B) require that any determination of 16 safety and effectiveness described in subpara- 17 graph (A) be made on the basis of adequate 18 and well-controlled investigations, including 19 clinical investigations, as appropriate, con- 20 ducted by experts qualified by scientific training 21 and experience to evaluate the safety and effec- 22 tiveness of drugs; 23 ‘‘(C) require the methods used in, and the 24 facilities and controls used for, the manufac- 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 11 •HR 1478 IH ture, processing, and packing of drugs in the 1 country to be adequate to preserve the identity, 2 quality, purity, and strength of the drugs; and 3 ‘‘(D) require the reporting of adverse reac- 4 tions to drugs and establish procedures to re- 5 call, and withdraw approval of, drugs found not 6 to be safe or effective. 7 ‘‘(f) LABELING.—Any qualifying insulin imported 8 that meets the labeling requirements described in sub- 9 section (b)(5)(A)(iv) is deemed not misbranded for pur- 10 poses of section 502. 11 ‘‘(g) INSULIN TESTING LABORATORIES.—The Sec- 12 retary may approve one or more laboratories to conduct 13 random testing of insulin sold by certified foreign sellers 14 to assess the chemical authenticity of such insulin. 15 ‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC- 16 TICES.—It is unlawful for a manufacturer, directly or indi- 17 rectly (including by being a party to a licensing agreement 18 or other agreement)— 19 ‘‘(1) to discriminate by charging a higher price 20 for an insulin sold to a certified foreign seller that 21 sells such insulin to an importer in accordance with 22 this section than the price that is charged, inclusive 23 of rebates or other incentives to the country from 24 which the insulin is exported, to another person that 25 VerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478 kjohnson on DSK79L0C42 with BILLS 12 •HR 1478 IH is in the same country and that does not import 1 such insulin into the United States in accordance 2 with this section; 3 ‘‘(2) except with respect to an insulin on the 4 drug shortage list under section 506E, discriminate 5 by denying, restricting, or delaying supplies of an in- 6 sulin to a certified foreign seller, on account of such 7 seller’s status as a certified foreign seller, that sells 8 such insulin to an importer in accordance with this 9 section, or by publicly, privately, or otherwise refus- 10 ing to do business with such a certified foreign seller 11 on account of such seller’s status as a certified for- 12 eign sel [Text truncated for display. 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