Safe and Secure Medicine Supply for Hardworking Americans Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 6885 To amend the Federal Food, Drug, and Cosmetic Act to prohibit the importa- tion of a drug or device that was manufactured at a banned foreign facility, to create incentives for pharmaceutical or device companies to increase manufacturing capacity in the United States, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 15, 2020 Mr. FLORES introduced the following bill; which was referred to the Com- mittee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Federal Food, Drug, and Cosmetic Act to prohibit the importation of a drug or device that was manufactured at a banned foreign facility, to create in- centives for pharmaceutical or device companies to in- crease manufacturing capacity in the United States, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 6885 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Safe and Secure Medi- 2 cine Supply for Hardworking Americans Act of 2020’’. 3 SEC. 2. TABLE OF CONTENTS. 4 The table of contents of this Act is as follows: 5 Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. Safe drug and device importation. Sec. 4. Imposition of additional duties on drugs from China, India, and other countries. Sec. 5. Secure Medicines Supply Fund. Sec. 6. Registry of drugs manufactured outside the United States. Sec. 7. Country-of-origin labeling. SEC. 3. SAFE DRUG AND DEVICE IMPORTATION. 6 (a) PROHIBITED ACT.—Section 301 of the Federal 7 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend- 8 ed by adding at the end the following: 9 ‘‘(fff) The importation of a drug or device that was 10 manufactured or processed at a banned foreign facility for 11 which an order is in effect under section 810.’’. 12 (b) ISSUANCE OF ORDER.—The Federal Food, Drug, 13 and Cosmetic Act is amended by inserting after section 14 809 of such Act (21 U.S.C. 384e) the following new sec- 15 tion: 16 ‘‘SEC. 810. BANNED FOREIGN FACILITIES. 17 ‘‘(a) DETERMINATION.—The Secretary shall issue an 18 order determining a facility to be a banned foreign facility 19 if— 20 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 6885 IH ‘‘(1) the facility manufactures or processes any 1 drug or device that is imported into the United 2 States; and 3 ‘‘(2) a Class I or Class II recall is issued by the 4 Food and Drug Administration for any drug or de- 5 vice that is manufactured or processed at such facil- 6 ity. 7 ‘‘(b) DURATION.— 8 ‘‘(1) BANNED FACILITIES WITH CLASS I RE- 9 CALL.—For a banned facility for which a Class I re- 10 call is issued as described in subsection (a)(2): 11 ‘‘(A) The designation of the banned facility 12 pursuant to an order under subsection (a), 13 based on an initial Class I recall of a drug or 14 device manufactured or processed at the facil- 15 ity, shall be in effect for the 10-year period be- 16 ginning on the date that is one year after the 17 issuance of the order. 18 ‘‘(B) The designation of the banned facility 19 pursuant to an order under subsection (a), 20 based on a subsequent Class I recall of a drug 21 or device manufactured or processed at the fa- 22 cility, shall be in effect permanently beginning 23 on the date that is one year after the issuance 24 of such order. 25 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 6885 IH ‘‘(2) BANNED FACILITIES WITH CLASS II RE- 1 CALL.—For a banned facility for which a class II re- 2 call is issued as described in subsection (a)(2): 3 ‘‘(A) The designation of the banned facility 4 pursuant to an order under subsection (a), 5 based on an initial Class II recall of a drug or 6 device manufactured or processed at the facil- 7 ity, shall be in effect for the 5-year period be- 8 ginning on the date that is one year after the 9 issuance of the order. 10 ‘‘(B) The designation of the banned facility 11 pursuant to an order under subsection (a), 12 based on a first subsequent Class II recall of a 13 drug or device manufactured or processed at 14 the facility, may be renewed to be in effect for 15 a period of 5 years beginning— 16 ‘‘(i) if the initial 5-year period under 17 subparagraph (A) has concluded, one year 18 from the date of the first subsequent re- 19 call; or 20 ‘‘(ii) if the initial 5-year period under 21 subparagraph (A) has not concluded, at 22 the conclusion of such initial 5-year period. 23 ‘‘(C) The designation of the banned facility 24 pursuant to an order under subsection (a), 25 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 6885 IH based on a second subsequent Class II recall of 1 a drug or device manufactured or processed at 2 the facility, shall be in effect permanently be- 3 ginning— 4 ‘‘(i) if the first subsequent 5-year pe- 5 riod under subparagraph (B) has con- 6 cluded, one year after the issuance of the 7 order; or 8 ‘‘(ii) if the first subsequent 5-year pe- 9 riod under subparagraph (B) has not con- 10 cluded, immediately. 11 ‘‘(c) DEFINITION.—In this section: 12 ‘‘(1) The term ‘banned facility’ means a banned 13 foreign facility for which an order is in effect under 14 subsection (a). 15 ‘‘(2) The terms ‘Class I’ and ‘Class II’, in con- 16 nection with a recall, mean classified as Class I or 17 Class II, respectively, by the Food and Drug Admin- 18 istration pursuant to section 7.41 of title 21, Code 19 of Federal Regulations (or any successor regula- 20 tions).’’. 21 (c) APPLICABILITY.—Section 810 of the Federal 22 Food, Drug, and Cosmetic Act, as added by subsection 23 (b), applies only with respect to recalls issued or reissued 24 on or after the date of enactment of this Act. 25 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 6885 IH (d) CIVIL MONETARY PENALTIES.—Subsection (f) of 1 section 303 of the Federal Food, Drug, and Cosmetic Act 2 (21 U.S.C. 333) is amended by adding at the end the fol- 3 lowing new paragraph: 4 ‘‘(10) Any person who violates section 301(fff) shall 5 be subject to a civil money penalty not to exceed— 6 ‘‘(A) if the violation involves a Class I recall, as 7 described in section 810(a)(2)— 8 ‘‘(i) $25,000,000 if the violation is the first 9 violation of section 301(fff) by such person; and 10 ‘‘(ii) $100,000,000 if the violation is a sub- 11 sequent violation of section 301(fff) by such 12 person; and 13 ‘‘(B) if the violation involves a Class II recall, 14 as described in section 810(a)(2)— 15 ‘‘(i) $10,000,000 if the violation is the first 16 violation of section 301(fff) by such person; and 17 ‘‘(ii) $50,000,000 if the violation is a sub- 18 sequent violation of section 301(fff) by such 19 person.’’. 20 SEC. 4. IMPOSITION OF ADDITIONAL DUTIES ON DRUGS 21 FROM CHINA, INDIA, AND OTHER COUNTRIES. 22 (a) DRUGS FROM CHINA.— 23 (1) IN GENERAL.—In addition to any other 24 duty, there is imposed a duty on drugs which are 25 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 6885 IH being imported or offered for import into the United 1 States (within the meaning of section 801 of the 2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3 381(a))) from the People’s Republic of China. 4 (2) RATE OF DUTY.—The rate of duty imposed 5 by paragraph (1) shall be 25 percent ad valorem. 6 (b) DRUGS FROM INDIA.— 7 (1) IN GENERAL.—In addition to any other 8 duty, there is imposed a duty on drugs which are 9 being imported or offered for import into the United 10 States (within the meaning of section 801 of the 11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 12 381(a))) from the Republic of India. 13 (2) RATE OF DUTY.—The rate of duty imposed 14 by paragraph (1) shall be 20 percent ad valorem. 15 (c) DRUGS FROM OTHER COUNTRIES.— 16 (1) IN GENERAL.—In addition to any other 17 duty, there is imposed a duty on drugs which are 18 being imported or offered for import into the United 19 States (within the meaning of section 801 of the 20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 381(a))) from any foreign country other than the 22 People’s Republic of China or the Republic of India. 23 (2) RATE OF DUTY.— 24 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 6885 IH (A) IN GENERAL.—Except as provided in 1 subparagraph (B), the rate of duty imposed by 2 paragraph (1) shall be 10 percent ad valorem. 3 (B) EXCEPTION.—In the case of a drug 4 that includes one or more active pharmaceutical 5 ingredients originating from the People’s Re- 6 public of China or the Republic of India, the 7 rate of duty imposed by paragraph (1) shall 8 be— 9 (i) 25 percent ad valorem for those 10 containing an active pharmaceutical ingre- 11 dient from China; and 12 (ii) 20 percent ad valorem for those 13 containing an active pharmaceutical ingre- 14 dient from India. 15 (d) EFFECTIVE DATE.—The provisions of this sec- 16 tion shall apply to articles described in subsections (a), 17 (b), and (c) entered, or withdrawn from warehouse for 18 consumption, on or after the date that is 15 days after 19 the date of the enactment of this Act. 20 SEC. 5. SECURE MEDICINES SUPPLY FUND. 21 (a) ESTABLISHMENT.—There is established in the 22 Treasury of the United States a fund, to be known as the 23 Secure Medicines Supply Fund (in this section referred 24 to as the ‘‘Fund’’), consisting of such amounts as may 25 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 6885 IH be deposited to the Fund pursuant to subsection (b) to 1 be used, in accordance with subsection (c), for the purpose 2 of supporting and incentivizing pharmaceutical or device 3 companies to invest in new pharmaceutical or device man- 4 ufacturing capacity in the 50 States, the District of Co- 5 lumbia, Puerto Rico, the Virgin Islands, Guam, American 6 Samoa, and the Commonwealth of the Northern Mariana 7 Islands. 8 (b) REQUIREMENTS.—To be eligible for investment 9 under subsection (a), new pharmaceutical or device manu- 10 facturing capacity shall meet each of the following: 11 (1) The products supported by the new pharma- 12 ceutical or device manufacturing capacity do not use 13 active pharmaceutical ingredients or parts manufac- 14 tured in China or India. 15 (2) At least 50 percent of the active pharma- 16 ceutical ingredients or parts for the total product 17 line of the respective company is manufactured in 18 any of the 50 States, the District of Columbia, 19 Puerto Rico, the Virgin Islands, Guam, American 20 Samoa, or the Commonwealth of the Northern Mar- 21 iana Islands. 22 (c) FUNDING.— 23 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 6885 IH (1) DUTIES.—Amounts collected from duties 1 imposed pursuant to section 4 shall be deposited in 2 the Fund, to remain available until expended. 3 (2) FINES.—Amounts collected from civil mone- 4 tary penalties imposed pursuant to paragraph (10) 5 of section 303(f) of the Federal Food, Drug, and 6 Cosmetic Act (21 U.S.C. 333(f)), as added by sec- 7 tion 3(d), shall be deposited in the Fund, to remain 8 available until expended. 9 (d) DISTRIBUTION OF FUNDS.— 10 (1) GRANTS.—The Secretary of Health and 11 Human Services shall establish a grant program to 12 support and incentivize pharmaceutical or device 13 companies to manufacture prescription drugs, active 14 pharmaceutical ingredients, or devices in any of the 15 50 States, the District of Columbia, Puerto Rico, the 16 Virgin Islands, Guam, American Samoa, and the 17 Commonwealth of the Northern Mariana Islands. 18 (2) LIMITATIONS ON USE OF FUNDS.—As a 19 condition on receipt of a grant under this section, 20 the recipient of the grant shall agree to use— 21 (A) not more than 10 percent of the grant 22 for new or expanded manufacturing capacity; 23 (B) not more than 50 percent of the grant 24 for training manufacturing workers; and 25 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 6885 IH (C) not more than 25 percent of the grant 1 for developing one or more new prescription 2 drugs, new active pharmaceutical ingredients, 3 or new antibiotics. 4 (3) SOURCE OF FUNDING.—All amounts used 5 to carry out this section shall be derived from the 6 Fund. 7 (e) REPORT.—Not later than one year after the date 8 of enactment of this Act, and annually thereafter, the Sec- 9 retary of Health and Human Services shall submit to the 10 Congress a report on the Fund. Each such report shall 11 address the following: 12 (1) The amounts deposited into the Fund in the 13 most recent three fiscal years. 14 (2) The distribution of such amounts pursuant 15 to grants under this section during the last three fis- 16 cal years, including the allocation of such amounts 17 for— 18 (A) new or expanded manufacturing capac- 19 ity; 20 (B) training workers; and 21 (C) developing new prescription drugs, new 22 active pharmaceutical ingredients, or new anti- 23 biotics. 24 VerDate Sep 11 2014 16:09 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H6885.IH H6885 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 6885 IH (f) DEVICE.—In this section, the term ‘‘device’’ has 1 the meaning given to such term in section 201 of the Fed- 2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 3 (g) SUNSET.—This section (other than subsection 4 (e)) shall cease to have effect beginning on the date that 5 is 10 years after the date of the enactment of this Act. 6 (h) UNUSED FUNDS RETURNED TO THE GENERAL 7 FUND OF THE TREASURY.—If any amounts remain in the 8 Fund after the date described in subsection (f), the Sec- 9 retary of the Treasury shall transfer such amounts to the 10 general fund of the Treasury. 11 SEC. 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