Affordable and Safe Prescription Drug Importation Act

I 116TH CONGRESS 1ST SESSION H. R. 447 To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, phar- macies, and individuals. IN THE HOUSE OF REPRESENTATIVES JANUARY 10, 2019 Mr. CUMMINGS (for himself, Mr. DOGGETT, Mr. WELCH, Mr. COHEN, Mr. KHANNA, Ms. LEE of California, Ms. NORTON, Ms. PINGREE, Ms. DELAURO, Mr. SHERMAN, Mr. POCAN, Ms. JAYAPAL, Ms. OMAR, Mr. KRISHNAMOORTHI, Ms. GABBARD, Mr. LANGEVIN, Ms. JACKSON LEE, Mr. BLUMENAUER, Ms. SCHAKOWSKY, Mr. NEGUSE, Ms. OCASIO-COR- TEZ, and Ms. TLAIB) 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 drugs 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 and Safe 4 Prescription Drug Importation Act’’. 5 VerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 2 •HR 447 IH SEC. 2. IMPORTING AFFORDABLE AND SAFE DRUGS. 1 (a) IN GENERAL.—Section 804 of the Federal Food, 2 Drug, and Cosmetic Act (21 U.S.C. 384) is amended to 3 read as follows: 4 ‘‘SEC. 804. IMPORTATION OF SAFE AND AFFORDABLE 5 DRUGS BY WHOLESALE DISTRIBUTORS, 6 PHARMACIES, AND INDIVIDUALS. 7 ‘‘(a) IN GENERAL.—Not later than 180 days after 8 the date of enactment of this section, the Secretary shall 9 promulgate regulations permitting the importation of 10 qualifying prescription drugs into the United States, in ac- 11 cordance with 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 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 3 •HR 447 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 prescription drugs into the United States in 4 accordance 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 16 prescription drugs to individuals in Canada, or, 17 subject to subsection (e), the permitted country 18 in which the pharmacy is located. 19 ‘‘(5) QUALIFYING PRESCRIPTION DRUG.—The 20 term ‘qualifying prescription drug’— 21 ‘‘(A) means a prescription drug that— 22 ‘‘(i) is approved for use in patients, 23 and marketed, in Canada, or subject to 24 subsection (e), approved for use in pa- 25 VerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 4 •HR 447 IH tients, and marketed, in another permitted 1 country; 2 ‘‘(ii) is manufactured in a facility reg- 3 istered under subsection (b)(1) or (i) of 4 section 510 that is in compliance with good 5 manufacturing practices regulations of the 6 Food and Drug Administration; 7 ‘‘(iii) has the same active ingredient 8 or ingredients, route of administration, and 9 strength as a prescription drug approved 10 under chapter V, or, for purposes of sub- 11 paragraph (B)(iv), is biosimilar to an ap- 12 proved biological product and has the same 13 route of administration and strength as the 14 approved biological product; and 15 ‘‘(iv) is labeled in accordance with— 16 ‘‘(I) the laws of Canada, or an- 17 other country from which importation 18 is permitted pursuant to subsection 19 (e); and 20 ‘‘(II) the requirements promul- 21 gated by the Secretary, which shall in- 22 clude labeling in English; 23 ‘‘(B) with respect to importers only, in- 24 cludes— 25 VerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 5 •HR 447 IH ‘‘(i) peritoneal dialysis solution; 1 ‘‘(ii) insulin; 2 ‘‘(iii) a drug for which a risk evalua- 3 tion and mitigation strategy is required 4 under section 505–1; 5 ‘‘(iv) biological products, as defined in 6 section 351 of the Public Health Service 7 Act that are proteins (except any chemi- 8 cally synthesized polypeptides) or analo- 9 gous products; and 10 ‘‘(v) intravenously infused drugs; and 11 ‘‘(C) does not include— 12 ‘‘(i) a controlled substance (as defined 13 in section 102 of the Controlled Sub- 14 stances Act); 15 ‘‘(ii) an anesthetic drug inhaled dur- 16 ing surgery; or 17 ‘‘(iii) a compounded drug. 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 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 6 •HR 447 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 prescription 15 drugs to importers or individuals who im- 16 port prescription drugs into the United 17 States in accordance with 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 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 7 •HR 447 IH ada, or, subject to subsection (e), another 1 permitted country; 2 ‘‘(ii) is engaged in the distribution or 3 dispensing of a prescription drug that is 4 imported or offered for importation into 5 the United 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 a qualifying prescription 14 drug to an individual in the United States 15 only after receiving a valid prescription, as 16 described 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 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 8 •HR 447 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 13 product testing to determine the chemical 14 authenticity of sample pharmaceutical 15 products; 16 ‘‘(viii) agrees to notify the Secretary, 17 importers, and individuals of product re- 18 calls in Canada, or pursuant to subsection 19 (e), the permitted country in which the 20 seller is located, and agrees to cease, or re- 21 frain from, exporting such product; 22 ‘‘(ix) has established, or will establish 23 or participate in, a process for resolving 24 grievances, as defined by the Secretary, 25 VerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 9 •HR 447 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 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 10 •HR 447 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 prescription drug described in sub- 6 section (b) from Canada or another country pursu- 7 ant to subsection (e) if such drug— 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, in quantities that do 13 not exceed a 90-day supply; and 14 ‘‘(C) is filled only after providing to the li- 15 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.—Be- 19 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 sec- 23 tion 2(d) of the Affordable and Safe Prescription Drug 24 Importation Act, that importation of qualifying prescrip- 25 VerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 11 •HR 447 IH tion drugs from Canada under this section resulted in cost 1 savings for consumers in the United States and increased 2 access to safe medication, the Secretary shall have the au- 3 thority to permit importation of qualifying prescription 4 drugs by importers and individuals from, in addition to 5 Canada, any country that— 6 ‘‘(1) is a member of the Organisation for Eco- 7 nomic Co-operation and Development; and 8 ‘‘(2) has statutory or regulatory standards for 9 the approval and sale of prescription drugs that are 10 comparable to the standards in the United States 11 and that— 12 ‘‘(A) authorizes the approval of drugs only 13 if a drug has been determined to be safe and 14 effective by experts employed by or acting on 15 behalf of a governmental entity and qualified by 16 scientific training and experience to evaluate 17 the safety and effectiveness of drugs; 18 ‘‘(B) requires that any determination of 19 safety and effectiveness described in subpara- 20 graph (A) be made on the basis of adequate 21 and well-controlled investigations, including 22 clinical investigations, as appropriate, con- 23 ducted by experts qualified by scientific training 24 VerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447 pbinns on DSK79D2C42PROD with BILLS 12 •HR 447 IH and experience to evaluate the safety and effec- 1 tiveness of drugs; 2 ‘‘(C) requires the methods used in, and the 3 facilities and controls used for, the manufac- 4 ture, processing, and packing of drugs in the 5 country to be adequate to preserve the identity, 6 quality, purity, and strength of the drugs; and 7 ‘‘(D) requires the reporting of adverse re- 8 actions to drugs and establish procedures to re- 9 call, and withdraw approval of, drugs found not 10 to be safe or effective. 11 ‘‘(f) LABELING.—Any qualifying prescription drug 12 imported that meets the labeling requirements described 13 in subsection (b)(5)(A)(iv) is deemed not misbranded for 14 purposes of section 502. 15 ‘‘(g) DRUG TESTING LABORATORIES.—The Sec- 16 retary may approve one or more laboratories to conduct 17 random testing of prescription drugs sold by certified for- 18 eign sellers to assess the chemical authenticity of such 19 drugs. 20 ‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC- 21 TIC [Text truncated for display. 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