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, pharmacies, 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. 

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 ‘‘Affordable Insulin Act 

5 of 2019’’. 

6 SEC. 2. IMPORTING AFFORDABLE AND SAFE INSULIN. 

7 (a) IN GENERAL.—The Federal Food, Drug, and 

8 Cosmetic Act is amended by inserting after section 804 

9 of such Act (21 U.S.C. 384) the following: 


kjohnson on DSK79L0C42 with BILLS
2 

•HR 1478 IH

1 ‘‘SEC. 804A. IMPORTATION OF SAFE AND AFFORDABLE IN2 SULIN BY WHOLESALE DISTRIBUTORS, PHAR3 MACIES, AND INDIVIDUALS. 

4 ‘‘(a) IN GENERAL.— 

5 ‘‘(1) REGULATION.—Not later than 180 days 

6 after the date of enactment of this section, the Sec7 retary shall promulgate regulations permitting the 

8 importation of qualifying insulin into the United 

9 States, in accordance with this section. 

10 ‘‘(2) RELATION TO SECTION 804.—Nothing in 

11 section 804 shall be construed to supercede or limit 

12 the provisions of this section. 

13 ‘‘(b) DEFINITIONS.—For purposes of this section: 

14 ‘‘(1) CERTIFIED FOREIGN SELLER.—The term 

15 ‘certified foreign seller’ means a licensed foreign 

16 pharmacy or foreign wholesale distributor that the 

17 Secretary certifies under subsection (d)(1)(B), that 

18 pays the fee required under subsection (d)(1)(C), 

19 and that is included on the list described in sub20 section (c). 

21 ‘‘(2) FOREIGN WHOLESALE DISTRIBUTOR.— 

22 The term ‘foreign wholesale distributor’ means a 

23 person (other than a manufacturer, a manufactur24 er’s co-licensed partner, a third-party logistics pro25 vider, or a repackager) engaged in wholesale dis26 tribution. 


kjohnson on DSK79L0C42 with BILLS
3 

•HR 1478 IH

1 ‘‘(3) IMPORTER.—The term ‘importer’ means a 

2 dispenser (as defined in section 581(3)) or wholesale 

3 distributor registered under section 503(e) who im4 ports insulin into the United States in accordance 

5 with this section. 

6 ‘‘(4) LICENSED FOREIGN PHARMACY.—The 

7 term ‘licensed foreign pharmacy’ means a pharmacy 

8 located in Canada, or subject to subsection (e), an9 other applicable country, that— 

10 ‘‘(A) operates in accordance with applica11 ble pharmacy standards set forth by the provin12 cial pharmacy rules and regulations enacted in 

13 Canada, or, subject to subsection (e), such ap14 plicable rules and regulations of the permitted 

15 country in which such seller is located; and 

16 ‘‘(B) is licensed to operate and dispense in17 sulin to individuals in Canada, or, subject to 

18 subsection (e), the permitted country in which 

19 the pharmacy is located. 

20 ‘‘(5) QUALIFYING INSULIN.—The term ‘quali21 fying insulin’ means insulin that— 

22 ‘‘(A) is approved for use in patients, and 

23 marketed, in Canada, or subject to subsection 

24 (e), approved for use in patients, and marketed, 

25 in another permitted country; 


kjohnson on DSK79L0C42 with BILLS
4 

•HR 1478 IH

1 ‘‘(B) is manufactured in a facility reg2 istered under subsection (b)(1) or (i) of section 

3 510 that is in compliance with good manufac4 turing practices regulations of the Food and 

5 Drug Administration; 

6 ‘‘(C) has the same active ingredient or in7 gredients, route of administration, and strength 

8 as an insulin approved under chapter V, or is 

9 biosimilar to an approved biological product and 

10 has the same route of administration and 

11 strength as the approved biological product; and 

12 ‘‘(D) is labeled in accordance with— 

13 ‘‘(i) the laws of Canada, or another 

14 country from which importation is per15 mitted pursuant to subsection (e); and 

16 ‘‘(ii) the requirements promulgated by 

17 the Secretary, which shall include labeling 

18 in English; 

19 ‘‘(6) VALID PRESCRIPTION.—The term ‘valid 

20 prescription’ means a prescription that is issued for 

21 a legitimate medical purpose in the usual course of 

22 professional practice by— 

23 ‘‘(A) a practitioner who has conducted at 

24 least 1 in-person medical evaluation of the pa25 tient; or 


kjohnson on DSK79L0C42 with BILLS
5 

•HR 1478 IH

1 ‘‘(B) a covering practitioner. 

2 ‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL3 ERS.—The Secretary shall publish on a dedicated internet 

4 website a list of certified foreign sellers, including the 

5 internet website address, physical address, and telephone 

6 number of each such certified foreign seller. 

7 ‘‘(d) ADDITIONAL CRITERIA.— 

8 ‘‘(1) CERTIFIED FOREIGN SELLERS.— 

9 ‘‘(A) IN GENERAL.—To be a certified for10 eign seller, such seller shall— 

11 ‘‘(i) be certified by the Secretary in 

12 accordance with subparagraph (B); 

13 ‘‘(ii) pay the registration fee estab14 lished under subparagraph (C); and 

15 ‘‘(iii) sell only qualifying insulin to im16 porters or individuals who import insulin 

17 into the United States in accordance with 

18 this section. 

19 ‘‘(B) CERTIFICATION.—To be a certified 

20 foreign seller, the Secretary shall certify that 

21 such seller— 

22 ‘‘(i) is a foreign wholesale distributor 

23 or licensed foreign pharmacy operating an 

24 establishment, which may include an online 

25 foreign pharmacy, that is located in CanVerDate 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

1 ada, or, subject to subsection (e), another 

2 permitted country; 

3 ‘‘(ii) is engaged in the distribution or 

4 dispensing of an insulin that is imported or 

5 offered for importation into the United 

6 States; 

7 ‘‘(iii) has been in existence for a pe8 riod of at least 5 years preceding the date 

9 of such certification and has a purpose 

10 other than to participate in the program 

11 established under this section; 

12 ‘‘(iv) in the case of a certified foreign 

13 seller that is a licensed foreign pharmacy, 

14 agrees to dispense qualifying insulin to an 

15 individual in the United States only after 

16 receiving a valid prescription, as described 

17 in paragraph (2)(C); 

18 ‘‘(v) has processes established by the 

19 seller, or participates in another estab20 lished process, to certify that the physical 

21 premises and data reporting procedures 

22 and licenses are in compliance with all ap23 plicable laws and regulations of Canada, 

24 or, subject to subsection (e), the permitted 

25 country in which the seller is located, and 


kjohnson on DSK79L0C42 with BILLS
7 

•HR 1478 IH

1 has implemented policies designed to mon2 itor ongoing compliance with such laws 

3 and regulations; 

4 ‘‘(vi) conducts or commits to partici5 pate in ongoing and comprehensive quality 

6 assurance programs and implements such 

7 quality assurance measures, including 

8 blind testing, to ensure the veracity and re9 liability of the findings of the quality as10 surance program; 

11 ‘‘(vii) agrees that, pursuant to sub12 section (g), laboratories approved by the 

13 Secretary may be authorized to conduct in14 sulin testing to determine the chemical au15 thenticity of sample insulin products; 

16 ‘‘(viii) agrees to notify the Secretary, 

17 importers, and individuals of insulin recalls 

18 in Canada, or pursuant to subsection (e), 

19 the permitted country in which the seller is 

20 located, and agrees to cease, or refrain 

21 from, exporting such insulin; 

22 ‘‘(ix) has established, or will establish 

23 or participate in, a process for resolving 

24 grievances, as defined by the Secretary, 


kjohnson on DSK79L0C42 with BILLS
8 

•HR 1478 IH

1 and will be held accountable for violations 

2 of established guidelines and rules; 

3 ‘‘(x) except as otherwise permitted 

4 under this section, does not sell products 

5 that the seller could not otherwise legally 

6 sell in Canada, or, subject to subsection 

7 (e), the permitted country in which such 

8 seller is located to customers in the United 

9 States; and 

10 ‘‘(xi) meets any other criteria estab11 lished by the Secretary. 

12 ‘‘(C) CERTIFICATION FEE.—Not later than 

13 30 days before the start of each fiscal year, the 

14 Secretary shall establish a fee to be collected 

15 from foreign sellers for such fiscal year that are 

16 certified under subparagraph (B), in an amount 

17 that is sufficient, and not more than necessary, 

18 to pay the costs of administering the program 

19 under this section, and enforcing this section 

20 pursuant to section 303(h), for that fiscal year. 

21 ‘‘(D) RECERTIFICATION.—A certification 

22 under subparagraph (B) shall be in effect for a 

23 period of 2 years, or until there is a material 

24 change in the circumstances under which the 

25 foreign seller meets the requirements under 


kjohnson on DSK79L0C42 with BILLS
9 

•HR 1478 IH

1 such subparagraph, whichever occurs earlier. A 

2 foreign seller may reapply for certification 

3 under such subparagraph (B), in accordance 

4 with a process established by the Secretary. 

5 ‘‘(2) INDIVIDUALS.—An individual may import 

6 a qualifying insulin described in subsection (b) from 

7 Canada or another country pursuant to subsection 

8 (e) if such qualifying insulin— 

9 ‘‘(A) is dispensed, including through an 

10 online pharmacy, by a certified foreign seller 

11 that is a licensed foreign pharmacy; 

12 ‘‘(B) is purchased for personal use by the 

13 individual, not for resale; and 

14 ‘‘(C) is filled only after providing to the li15 censed foreign pharmacy a valid prescription 

16 issued by a health care practitioner licensed to 

17 practice in a State in the United States. 

18 ‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be19 ginning on the date that is 2 years after the date on which 

20 final regulations are promulgated to carry out this section, 

21 if, based on a review of the evidence obtained after such 

22 effective date, including the reports submitted under sec23 tion 2(d) of the Affordable Insulin Act of 2019, that im24 portation of qualifying insulin from Canada under this 

25 section resulted in cost savings for consumers in the 


kjohnson on DSK79L0C42 with BILLS
10 

•HR 1478 IH

1 United States and increased access to safe insulin, the 

2 Secretary shall have the authority to permit importation 

3 of qualifying insulin by importers and individuals from, 

4 in addition to Canada, any country that— 

5 ‘‘(1) is a member of the Organisation for Eco6 nomic Co-operation and Development; and 

7 ‘‘(2) has statutory or regulatory standards for 

8 the approval and sale of insulin that are comparable 

9 to the standards in the United States and that— 

10 ‘‘(A) authorize the approval of drugs only 

11 if a drug has been determined to be safe and 

12 effective by experts employed by or acting on 

13 behalf of a governmental entity and qualified by 

14 scientific training and experience to evaluate 

15 the safety and effectiveness of drugs; 

16 ‘‘(B) require that any determination of 

17 safety and effectiveness described in subpara18 graph (A) be made on the basis of adequate 

19 and well-controlled investigations, including 

20 clinical investigations, as appropriate, con21 ducted by experts qualified by scientific training 

22 and experience to evaluate the safety and effec23 tiveness of drugs; 

24 ‘‘(C) require the methods used in, and the 

25 facilities and controls used for, the manufacVerDate 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

1 ture, processing, and packing of drugs in the 

2 country to be adequate to preserve the identity, 

3 quality, purity, and strength of the drugs; and 

4 ‘‘(D) require the reporting of adverse reac5 tions to drugs and establish procedures to re6 call, and withdraw approval of, drugs found not 

7 to be safe or effective. 

8 ‘‘(f) LABELING.—Any qualifying insulin imported 

9 that meets the labeling requirements described in sub10 section (b)(5)(A)(iv) is deemed not misbranded for pur11 poses of section 502. 

12 ‘‘(g) INSULIN TESTING LABORATORIES.—The Sec13 retary may approve one or more laboratories to conduct 

14 random testing of insulin sold by certified foreign sellers 

15 to assess the chemical authenticity of such insulin. 

16 ‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC17 TICES.—It is unlawful for a manufacturer, directly or indi18 rectly (including by being a party to a licensing agreement 

19 or other agreement)— 

20 ‘‘(1) to discriminate by charging a higher price 

21 for an insulin sold to a certified foreign seller that 

22 sells such insulin to an importer in accordance with 

23 this section than the price that is charged, inclusive 

24 of rebates or other incentives to the country from 

25 which the insulin is exported, to another person that 


kjohnson on DSK79L0C42 with BILLS
12 

•HR 1478 IH

1 is in the same country and that does not import 

2 such insulin into the United States in accordance 

3 with this section; 

4 ‘‘(2) except with respect to an insulin on the 

5 drug shortage list under section 506E, discriminate 

6 by denying, restricting, or delaying supplies of an in7 sulin to a certified foreign seller, on account of such 

8 seller’s status as a certified foreign seller, that sells 

9 such insulin to an importer in accordance with this 

10 section, or by publicly, privately, or otherwise refus11 ing to do business with such a certified foreign seller 

12 on account of such seller’s status as a certified for13 eign seller; 

14 ‘‘(3) cause there to be a difference (including a 

15 difference in active ingredient, route of administra16 tion, bioequivalence, strength, formulation, manufac17 turing establishment, manufacturing process, or per18 son that manufactures the insulin) between an insu19 lin for distribution in the United States and the in20 sulin for distribution in Canada or another per21 mitted country, subject to subsection (e), for the 

22 purpose of avoiding sales by certified foreign sellers; 

23 or 

24 ‘‘(4) except with respect to an insulin on the 

25 drug shortage list under section 506E, engage in 


kjohnson on DSK79L0C42 with BILLS
13 

•HR 1478 IH

1 any other action to restrict, prohibit, or delay the 

2 importation of an insulin under this section. 

3 ‘‘(i) INFORMATION AND RECORDS.— 

4 ‘‘(1) BIANNUAL REPORTS.—Each importer shall 

5 submit biannual reports to the Secretary which shall 

6 contain, for each qualifying insulin imported into the 

7 United States— 

8 ‘‘(A) the unique facility identifier of the 

9 manufacturer of the insulin, described in sec10 tion 510; 

11 ‘‘(B) the transaction information described 

12 in section 581(26) (other than the information 

13 described in subparagraph (C)); and 

14 ‘‘(C) the price paid by the importer for the 

15 insulin. 

16 ‘‘(2) MAINTENANCE OF RECORDS BY SEC17 RETARY.—The Secretary shall maintain information 

18 and documentation submitted under paragraph (1) 

19 for such period of time as the Secretary determines 

20 to be appropriate. 

21 ‘‘(j) SUSPENSION OF IMPORTATION.— 

22 ‘‘(1) PATTERNS OF NONCOMPLIANCE.—The 

23 Secretary shall require that importation of a specific 

24 qualifying insulin or importation by a specific cer25 tified foreign seller or importer pursuant to this secVerDate Sep 11 2014 03:07 Mar 14, 2019 Jkt 089200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H1478.IH H1478

kjohnson on DSK79L0C42 with BILLS
14 

•HR 1478 IH

1 tion be immediately suspended if the Secretary de2 termines that there is a pattern of importation of 

3 such specific insulin or by such specific seller or im4 porter that involves counterfeit drugs, drugs that 

5 have been recalled or withdrawn, or drugs in viola6 tion of any requirement of this section, until an in7 vestigation is completed and the Secretary deter8 mines that importation of such drug or by such sell9 er or importer does not endanger the public health. 

10 ‘‘(2) TEMPORARY SUSPENSION.—The Secretary 

11 may require that importation of a specific qualifying 

12 insulin or importation by a specific certified foreign 

13 seller or importer pursuant to this section be tempo14 rarily suspended if, with respect to such insulin, sell15 er, or importer, there is a violation of any require16 ment of this section or if the Secretary determines 

17 that importation of such insulin or by such seller or 

18 importer might endanger the public health. Such 

19 temporary suspension shall apply until the Secretary 

20 completes an investigation and determines that im21 portation of such insulin or by such seller or im22 porter does not endanger the public health. 

23 ‘‘(k) SUPPLY CHAIN SECURITY.— 

24 ‘‘(1) PURCHASE FROM REGISTERED FACILITIES

25 AND CERTIFIED FOREIGN SELLERS.— 


kjohnson on DSK79L0C42 with BILLS
15 

•HR 1478 IH

1 ‘‘(A) IN GENERAL.—Except as provided in 

2 subparagraph (B), certified foreign sellers who 

3 sell qualifying insulin for importation into the 

4 United States pursuant to this section may pur5 chase such insulin only from manufacturers or 

6 entities registered under section 510 or other 

7 certified foreign sellers. 

8 ‘‘(B) EXCEPTION.—Certified foreign sellers 

9 who sell qualifying insulin for importation into 

10 the United States pursuant to this section may 

11 purchase such insulin from foreign sellers in 

12 Canada or another permitted country, even if 

13 such foreign seller is not a manufacturer reg14 istered under section 510 or a certified foreign 

15 seller, if the Secretary enters into a memo16 randum of understanding or cooperative agree17 ment with Canada, or such other permitted 

18 country, to ensure compliance, to the extent ap19 propriate and feasible, with subchapter H of 

20 chapter V. The Secretary shall seek to enter 

21 into such a memorandum of understanding or 

22 cooperative agreement with Canada and each 

23 country from which importation is permitted 

24 under subsection (e). 


kjohnson on DSK79L0C42 with BILLS
16 

•HR 1478 IH

1 ‘‘(2) IMPORTATION TRACING.—Certified foreign 

2 sellers shall provide importers with the unique facil3 ity identifier associated with the manufacturer reg4 istered under section 510 of the qualifying insulin 

5 and the information under paragraph (25), para6 graph (26) (other than subparagraph (C)), and sub7 paragraphs (D), (F), and (G) of paragraph (27) of 

8 section 581. Certified foreign sellers shall provide 

9 such information to individuals purchasing such in10 sulin, upon request. 

11 ‘‘(l) REMS.—In the case of an importer that imports 

12 a qualifying insulin, where the insulin has the same active 

13 ingredient or ingredients, route of administration, and 

14 strength as an insulin approved under chapter V, or is 

15 biosimilar to an approved biological product and has the 

16 same route of administration and strength as the approved 

17 biological product, and where the approved product is sub18 ject to elements to assure safe use under section 505–1, 

19 such importer shall be subject to such elements to assure 

20 safe use, as applicable and appropriate. 

21 ‘‘(m) CONSTRUCTION.—Nothing in this section limits 

22 the authority of the Secretary relating to the importation 

23 of insulin, other than with respect to section 801(d)(1) 

24 as provided in this section.’’. 


kjohnson on DSK79L0C42 with BILLS
17 

•HR 1478 IH

1 (b) PENALTIES WITH RESPECT TO ONLINE PHAR2 MACIES.—Section 303 of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 333) is amended by adding at 

4 the end the following: 

5 ‘‘(h) In the case of person operating an internet 

6 website, whether in the United States or in another coun7 try, that violates section 301(aa) by— 

8 ‘‘(1) selling, by means of the internet, with the 

9 intent to defraud or mislead or with reckless dis10 regard for safety of the public, an adulterated or 

11 counterfeit drug to an individual in the United 

12 States; or 

13 ‘‘(2) dispenses, by means of the internet, a drug 

14 to an individual in the United States who the person 

15 knows or has reasonable cause to believe, does not 

16 possess a valid prescription for that drug, 

17 such person shall be imprisoned for not more than 10 

18 years or fined not more than $250,000.’’. 

19 (c) NO PREEMPTION.—Nothing in this Act, including 

20 the amendments made by this Act, shall be construed to 

21 preempt, alter, displace, abridge, or supplant any remedy 

22 available under any State or Federal law, including com23 mon law, that provides a remedy for civil relief. 

24 (d) REPORTS.— 


kjohnson on DSK79L0C42 with BILLS
18 

•HR 1478 IH

1 (1) HHS.—Not later than 1 year after the date 

2 on which final regulations are promulgated to carry 

3 out section 804A of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 384), as added by this Act, 

5 and every 2 years thereafter, the Secretary of 

6 Health and Human Services, after consultation with 

7 appropriate Federal agencies, shall submit to Con8 gress and make public a report on the importation 

9 of insulin into the United States. 

10 (2) GAO REPORT.—Not later than 18 months 

11 after the date on which final regulations are promul12 gated to carry out section 804A of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 384), as 

14 added by this Act, the Comptroller General of the 

15 United States shall submit to Congress a report con16 taining an analysis of the implementation of the 

17 amendments made by this Act, including a review of 

18 drug safety and cost-savings and expenses, including 

19 cost-savings to consumers in the United States and 

20 trans-shipment and importation tracing processes, 

21 resulting from such implementation. 

Æ 


kjohnson on DSK79L0C42 with BILLS