Affordable and Safe Prescription Drug Importation Act

II 116TH CONGRESS 1ST SESSION S. 97 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 SENATE OF THE UNITED STATES JANUARY 10, 2019 Mr. SANDERS (for himself, Mr. BOOKER, Mr. CASEY, Ms. BALDWIN, Mr. BLUMENTHAL, Mr. BROWN, Ms. CANTWELL, Mrs. GILLIBRAND, Ms. HARRIS, Ms. HASSAN, Mr. HEINRICH, Mr. KING, Mr. LEAHY, Ms. KLO- BUCHAR, Mr. MANCHIN, Mr. MERKLEY, Mr. REED, Mrs. SHAHEEN, Ms. SMITH, Ms. STABENOW, Mr. UDALL, Mr. VAN HOLLEN, Ms. WARREN, and Mr. WHITEHOUSE) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 2 •S 97 IS 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 the Affordable and Safe Prescrip- 9 tion Drug Importation Act, the Secretary shall promulgate 10 regulations permitting the importation of qualifying pre- 11 scription drugs into the United States, in accordance with 12 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 sub- 20 section (c). 21 ‘‘(2) FOREIGN WHOLESALE DISTRIBUTOR.— 22 The term ‘foreign wholesale distributor’ means a 23 person (other than a manufacturer, a manufactur- 24 er’s co-licensed partner, a third-party logistics pro- 25 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 3 •S 97 IS vider, or a repackager) engaged in wholesale dis- 1 tribution. 2 ‘‘(3) IMPORTER.—The term ‘importer’ means a 3 dispenser (as defined in section 581(3)) or wholesale 4 distributor registered under section 503(e) who im- 5 ports prescription drugs into the United States in 6 accordance with this section. 7 ‘‘(4) LICENSED FOREIGN PHARMACY.—The 8 term ‘licensed foreign pharmacy’ means a pharmacy 9 located in Canada, or subject to subsection (e), an- 10 other applicable country, that— 11 ‘‘(A) operates in accordance with applica- 12 ble pharmacy standards set forth by the provin- 13 cial pharmacy rules and regulations enacted in 14 Canada, or, subject to subsection (e), such ap- 15 plicable rules and regulations of the permitted 16 country in which such seller is located; and 17 ‘‘(B) is licensed to operate and dispense 18 prescription drugs to individuals in Canada, or, 19 subject to subsection (e), the permitted country 20 in which the pharmacy is located. 21 ‘‘(5) QUALIFYING PRESCRIPTION DRUG.—The 22 term ‘qualifying prescription drug’— 23 ‘‘(A) means a prescription drug that— 24 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 4 •S 97 IS ‘‘(i) is approved for use in patients, 1 and marketed, in Canada, or subject to 2 subsection (e), approved for use in pa- 3 tients, and marketed, in another permitted 4 country; 5 ‘‘(ii) is manufactured in a facility reg- 6 istered under subsection (b)(1) or (i) of 7 section 510 that is in compliance with good 8 manufacturing practices regulations of the 9 Food and Drug Administration; 10 ‘‘(iii) has the same active ingredient 11 or ingredients, route of administration, and 12 strength as a prescription drug approved 13 under chapter V, or, for purposes of sub- 14 paragraph (B)(iv), is biosimilar to an ap- 15 proved biological product and has the same 16 route of administration and strength as the 17 approved biological product; and 18 ‘‘(iv) is labeled in accordance with— 19 ‘‘(I) the laws of Canada, or an- 20 other country from which importation 21 is permitted pursuant to subsection 22 (e); and 23 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 5 •S 97 IS ‘‘(II) the requirements promul- 1 gated by the Secretary, which shall in- 2 clude labeling in English; 3 ‘‘(B) with respect to importers only, in- 4 cludes— 5 ‘‘(i) peritoneal dialysis solution; 6 ‘‘(ii) insulin; 7 ‘‘(iii) a drug for which a risk evalua- 8 tion and mitigation strategy is required 9 under section 505–1; 10 ‘‘(iv) biological products, as defined in 11 section 351 of the Public Health Service 12 Act that are proteins (except any chemi- 13 cally synthesized polypeptides) or analo- 14 gous products; and 15 ‘‘(v) intravenously infused drugs; and 16 ‘‘(C) does not include— 17 ‘‘(i) a controlled substance (as defined 18 in section 102 of the Controlled Sub- 19 stances Act); 20 ‘‘(ii) an anesthetic drug inhaled dur- 21 ing surgery; or 22 ‘‘(iii) a compounded drug. 23 ‘‘(6) VALID PRESCRIPTION.—The term ‘valid 24 prescription’ means a prescription that is issued for 25 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 6 •S 97 IS a legitimate medical purpose in the usual course of 1 professional practice by— 2 ‘‘(A) a practitioner who has conducted at 3 least one in-person medical evaluation of the 4 patient; or 5 ‘‘(B) a covering practitioner. 6 ‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL- 7 ERS.—The Secretary shall publish on a dedicated internet 8 website a list of certified foreign sellers, including the 9 internet website address, physical address, and telephone 10 number of each such certified foreign seller. 11 ‘‘(d) ADDITIONAL CRITERIA.— 12 ‘‘(1) CERTIFIED FOREIGN SELLERS.— 13 ‘‘(A) IN GENERAL.—To be a certified for- 14 eign seller, such seller shall— 15 ‘‘(i) be certified by the Secretary in 16 accordance with subparagraph (B); 17 ‘‘(ii) pay the registration fee estab- 18 lished under subparagraph (C); and 19 ‘‘(iii) sell only qualifying prescription 20 drugs to importers or individuals who im- 21 port prescription drugs into the United 22 States in accordance with this section. 23 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 7 •S 97 IS ‘‘(B) CERTIFICATION.—To be a certified 1 foreign seller, the Secretary shall certify that 2 such seller— 3 ‘‘(i) is a foreign wholesale distributor 4 or licensed foreign pharmacy operating an 5 establishment, which may include an online 6 foreign pharmacy, that is located in Can- 7 ada, or, subject to subsection (e), another 8 permitted country; 9 ‘‘(ii) is engaged in the distribution or 10 dispensing of a prescription drug that is 11 imported or offered for importation into 12 the United States; 13 ‘‘(iii) has been in existence for a pe- 14 riod of at least 5 years preceding the date 15 of such certification and has a purpose 16 other than to participate in the program 17 established under this section; 18 ‘‘(iv) in the case of a certified foreign 19 seller that is a licensed foreign pharmacy, 20 agrees to dispense a qualifying prescription 21 drug to an individual in the United States 22 only after receiving a valid prescription, as 23 described in paragraph (2)(C); 24 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 8 •S 97 IS ‘‘(v) has processes established by the 1 seller, or participates in another estab- 2 lished process, to certify that the physical 3 premises and data reporting procedures 4 and licenses are in compliance with all ap- 5 plicable laws and regulations of Canada, 6 or, subject to subsection (e), the permitted 7 country in which the seller is located, and 8 has implemented policies designed to mon- 9 itor ongoing compliance with such laws 10 and regulations; 11 ‘‘(vi) conducts or commits to partici- 12 pate in ongoing and comprehensive quality 13 assurance programs and implements such 14 quality assurance measures, including 15 blind testing, to ensure the veracity and re- 16 liability of the findings of the quality as- 17 surance program; 18 ‘‘(vii) agrees that, pursuant to sub- 19 section (g), laboratories approved by the 20 Secretary may be authorized to conduct 21 product testing to determine the chemical 22 authenticity of sample pharmaceutical 23 products; 24 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 9 •S 97 IS ‘‘(viii) agrees to notify the Secretary, 1 importers, and individuals of product re- 2 calls in Canada, or pursuant to subsection 3 (e), the permitted country in which the 4 seller is located, and agrees to cease, or re- 5 frain from, exporting such product; 6 ‘‘(ix) has established, or will establish 7 or participate in, a process for resolving 8 grievances, as defined by the Secretary, 9 and will be held accountable for violations 10 of established guidelines and rules; 11 ‘‘(x) except as otherwise permitted 12 under this section, does not sell products 13 that the seller could not otherwise legally 14 sell in Canada, or, subject to subsection 15 (e), the permitted country in which such 16 seller is located to customers in the United 17 States; and 18 ‘‘(xi) meets any other criteria estab- 19 lished by the Secretary. 20 ‘‘(C) CERTIFICATION FEE.—Not later than 21 30 days before the start of each fiscal year, the 22 Secretary shall establish a fee to be collected 23 from foreign sellers for such fiscal year that are 24 certified under subparagraph (B), in an amount 25 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 10 •S 97 IS that is sufficient, and not more than necessary, 1 to pay the costs of administering the program 2 under this section, and enforcing this section 3 pursuant to section 303(h), for that fiscal year. 4 ‘‘(D) RECERTIFICATION.—A certification 5 under subparagraph (B) shall be in effect for a 6 period of 2 years, or until there is a material 7 change in the circumstances under which the 8 foreign seller meets the requirements under 9 such subparagraph, whichever occurs earlier. A 10 foreign seller may reapply for certification 11 under such subparagraph (B), in accordance 12 with a process established by the Secretary. 13 ‘‘(2) INDIVIDUALS.—An individual may import 14 a qualifying prescription drug described in sub- 15 section (b) from Canada or another country pursu- 16 ant to subsection (e) if such drug— 17 ‘‘(A) is dispensed, including through an 18 online pharmacy, by a certified foreign seller 19 that is a licensed foreign pharmacy; 20 ‘‘(B) is purchased for personal use by the 21 individual, not for resale, in quantities that do 22 not exceed a 90-day supply; and 23 ‘‘(C) is filled only after providing to the li- 24 censed foreign pharmacy a valid prescription 25 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 11 •S 97 IS issued by a health care practitioner licensed to 1 practice in a State in the United States. 2 ‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be- 3 ginning on the date that is 2 years after the date on which 4 final regulations are promulgated to carry out this section, 5 if, based on a review of the evidence obtained after such 6 effective date, including the reports submitted under sec- 7 tion 2(d) of the Affordable and Safe Prescription Drug 8 Importation Act, that importation of qualifying prescrip- 9 tion drugs from Canada under this section resulted in cost 10 savings for consumers in the United States and increased 11 access to safe medication, the Secretary shall have the au- 12 thority to permit importation of qualifying prescription 13 drugs by importers and individuals from, in addition to 14 Canada, any country that— 15 ‘‘(1) is a member of the Organisation for Eco- 16 nomic Co-operation and Development; and 17 ‘‘(2) has statutory or regulatory standards for 18 the approval and sale of prescription drugs that are 19 comparable to the standards in the United States 20 and that— 21 ‘‘(A) authorizes the approval of drugs only 22 if a drug has been determined to be safe and 23 effective by experts employed by or acting on 24 behalf of a governmental entity and qualified by 25 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 12 •S 97 IS scientific training and experience to evaluate 1 the safety and effectiveness of drugs; 2 ‘‘(B) requires that any determination of 3 safety and effectiveness described in subpara- 4 graph (A) be made on the basis of adequate 5 and well-controlled investigations, including 6 clinical investigations, as appropriate, con- 7 ducted by experts qualified by scientific training 8 and experience to evaluate the safety and effec- 9 tiveness of drugs; 10 ‘‘(C) requires the methods used in, and the 11 facilities and controls used for, the manufac- 12 ture, processing, and packing of drugs in the 13 country to be adequate to preserve the identity, 14 quality, purity, and strength of the drugs; and 15 ‘‘(D) requires the reporting of adverse re- 16 actions to drugs and establish procedures to re- 17 call, and withdraw approval of, drugs found not 18 to be safe or effective. 19 ‘‘(f) LABELING.—Any qualifying prescription drug 20 imported that meets the labeling requirements described 21 in subsection (b)(5)(A)(iv) is deemed not misbranded for 22 purposes of section 502. 23 ‘‘(g) DRUG TESTING LABORATORIES.—The Sec- 24 retary may approve one or more laboratories to conduct 25 VerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97 kjohnson on DSK79L0C42 with BILLS 13 •S 97 IS random t [Text truncated for display. 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