IIB 

115TH CONGRESS 

2D SESSION H. R. 5228 

IN THE SENATE OF THE UNITED STATES 

JUNE 13, 2018 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To strengthen the authorities of the Food and Drug Administration to address counterfeit drugs, illegal and synthetic opioids, and opioid-like substances, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Stop Counterfeit Drugs by Regulating and Enhancing 

4 Enforcement Now Act’’ or the ‘‘SCREEN Act’’. 

5 (b) TABLE OF CONTENTS.—The table of contents of 

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Detention, refusal, and destruction of drugs offered for importation. 

Sec. 3. Notification, nondistribution, and recall of adulterated or misbranded 

drug products. 

Sec. 4. Single source pattern of shipments of adulterated or misbranded drugs. 

Sec. 5. Fund to strengthen efforts of FDA to combat the opioid and substance 

use epidemic. 

Sec. 6. Consideration of potential for misuse and abuse required for drug approval. 

7 SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF 

8 DRUGS OFFERED FOR IMPORTATION. 

9 (a) INCREASING THE MAXIMUM DOLLAR AMOUNT OF

10 DRUGS SUBJECT TO DESTRUCTION.—The sixth sentence 

11 in section 801(a) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 381(a)) is amended by striking ‘‘ex13 cept that the Secretary’’ and all that follows through the 

14 two periods at the end and inserting ‘‘except that the Sec15 retary of Health and Human Services may destroy, with16 out the opportunity for export, any drug refused admission 

17 under this section, if such drug is declared to be valued 

18 at an amount that is $2,500 or less (or such higher 

19 amount as the Secretary of the Treasury may set by regu20 lation pursuant to section 498(a)(1) of the Tariff Act of 

21 1930 or such higher amount as the Commissioner of Food 


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1 and Drugs may set based on a finding by the Commis2 sioner that the higher amount is in the interest of public 

3 health), or if such drug is entering the United States by 

4 mail, and was not brought into compliance as described 

5 under subsection (b).’’. 

6 (b) DESTRUCTION OF ARTICLES OF CONCERN.—The 

7 sixth sentence of section 801(a) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended 

9 by subsection (a), is further amended by inserting before 

10 the period at the end the following: ‘‘; and the Secretary 

11 of Health and Human Services may destroy, without the 

12 opportunity for export, any article refused admission 

13 under clause (6) of the third sentence of this subsection’’. 

14 (c) TECHNICAL AMENDMENTS.—The seventh, eighth, 

15 and ninth sentences of section 801(a) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 381(a)) are amend17 ed— 

18 (1) by striking ‘‘a drug’’ each place it appears 

19 and inserting ‘‘an article’’; and 

20 (2) by striking ‘‘the drug’’ each place it appears 

21 and inserting ‘‘the article’’. 

22 (d) RULE OF CONSTRUCTION.—The last sentence in 

23 section 801(a) of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 381(a)) is amended to read as follows: 

25 ‘‘Clauses (2), (5), and (6) of the third sentence of this 


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1 subsection shall not be construed to prohibit the admission 

2 of narcotic or nonnarcotic drugs or other substances, the 

3 importation of which is permitted under the Controlled 

4 Substances Import and Export Act.’’. 

5 SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

6 OF ADULTERATED OR MISBRANDED DRUG 

7 PRODUCTS. 

8 (a) PROHIBITED ACTS.—Section 301 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend10 ed by adding at the end the following: 

11 ‘‘(eee) The failure to comply with any order issued 

12 under section 569D.’’. 

13 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

14 OF ADULTERATED OR MISBRANDED DRUGS.—Subchapter 

15 E of chapter V of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 360bbb et seq.) is amended by adding at 

17 the end the following: 

18 ‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RE19 CALL OF ADULTERATED OR MISBRANDED 

20 DRUGS. 

21 ‘‘(a) ORDER TO CEASE DISTRIBUTION AND RE22 CALL.— 

23 ‘‘(1) IN GENERAL.—Upon a determination that 

24 the use or consumption of, or exposure to, a drug 

25 may present an imminent or substantial hazard to 


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1 the public health, the Secretary shall issue an order 

2 requiring any person who distributes the drug to im3 mediately cease distribution of the drug. 

4 ‘‘(2) HEARING.—An order under paragraph (1) 

5 shall provide the person subject to the order with an 

6 opportunity for an informal hearing, to be held not 

7 later than 10 days after the date of issuance of the 

8 order, on— 

9 ‘‘(A) the actions required by the order; and 

10 ‘‘(B) whether the order should be amended 

11 to require a recall of the drug. 

12 ‘‘(3) INADEQUATE GROUNDS.—If, after pro13 viding an opportunity for a hearing under paragraph 

14 (2), the Secretary determines that inadequate 

15 grounds exist to support the actions required by the 

16 order, the Secretary shall vacate the order. 

17 ‘‘(4) AMENDMENT TO ORDER TO REQUIRE RE18 CALL.—If, after providing an opportunity for an in19 formal hearing under paragraph (2), the Secretary 

20 determines that the order should be amended to in21 clude a recall of the drug with respect to which the 

22 order was issued, the Secretary shall— 

23 ‘‘(A) amend the order to require a recall; 

24 and 


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1 ‘‘(B) after consultation with the drug 

2 sponsor, specify a timetable in which the recall 

3 will occur. 

4 ‘‘(5) NOTICE TO PERSONS AFFECTED.—An 

5 order under this subsection shall require any person 

6 who distributes the drug to provide for notice, in7 cluding to individuals as appropriate, to persons who 

8 may be affected by the order to cease distribution of 

9 or recall the drug, as applicable. 

10 ‘‘(6) ACTION FOLLOWING ORDER.—Any person 

11 who is subject to an order under paragraph (1) or 

12 (4) shall immediately cease distribution of or recall, 

13 as applicable, the drug and provide notification as 

14 required by such order. 

15 ‘‘(b) NOTICE TO CONSUMERS AND HEALTH OFFI16 CIALS.—The Secretary shall, as the Secretary determines 

17 to be necessary, provide notice of a recall order under this 

18 section to— 

19 ‘‘(1) consumers to whom the drug was, or may 

20 have been, distributed; and 

21 ‘‘(2) appropriate State and local health officials. 

22 ‘‘(c) ORDER TO RECALL.— 

23 ‘‘(1) CONTENTS.—An order to recall a drug 

24 under subsection (a) shall— 


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1 ‘‘(A) require periodic reports to the Sec2 retary describing the progress of the recall; and 

3 ‘‘(B) provide for notice, including to indi4 viduals as appropriate, to persons who may be 

5 affected by the recall. 

6 ‘‘(2) ASSISTANCE ALLOWED.—In providing for 

7 notice under paragraph (1)(B), the Secretary may 

8 allow for the assistance of health professionals, State 

9 or local officials, or other individuals designated by 

10 the Secretary. 

11 ‘‘(3) NONDELEGATION.—An order under this 

12 section shall be ordered by the Secretary or an offi13 cial designated by the Secretary. An official may not 

14 be so designated under this section unless the offi15 cial is the Director of the Center for Drug Evalua16 tion and Research, is an official senior to such Di17 rector, or is so designated by such Director. 

18 ‘‘(d) SAVINGS CLAUSE.—Nothing contained in this 

19 section shall be construed as limiting— 

20 ‘‘(1) the authority of the Secretary to issue an 

21 order to cease distribution of, or to recall, an drug 

22 under any other provision of this Act or the Public 

23 Health Service Act; or 

24 ‘‘(2) the ability of the Secretary to request any 

25 person to perform a voluntary activity related to any 


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1 drug subject to this Act or the Public Health Service 

2 Act.’’. 

3 (c) DRUGS SUBJECT TO REFUSAL.—The third sen4 tence of subsection (a) of section 801 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 

6 inserting ‘‘or (5) in the case of a drug, such drug is sub7 ject to an order under section 568 to cease distribution 

8 of or recall the drug,’’ before ‘‘then such article shall be 

9 refused admission’’. 

10 (d) APPLICATION.—Sections 301(eee) and 569D of 

11 the Federal Food, Drug, and Cosmetic Act, as added by 

12 subsections (a) and (b), shall apply with respect to a drug 

13 as of such date, not later than 1 year after the date of 

14 the enactment of this Act, as the Secretary of Health and 

15 Human Services shall specify. 

16 SEC. 4. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADUL17 TERATED OR MISBRANDED DRUGS. 

18 Section 801 of the Federal Food, Drug, and Cosmetic 

19 Act is amended by adding at the end the following: 

20 ‘‘(t) SINGLE SOURCE PATTERN OF SHIPMENTS OF

21 ADULTERATED OR MISBRANDED DRUGS.—If the Sec22 retary identifies a pattern of adulterated or misbranded 

23 drugs being offered for import from the same manufac24 turer, distributor, or importer, the Secretary may by order 

25 choose to treat all drugs being offered for import from 


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1 such manufacturer, distributor, or importer as adulterated 

2 or misbranded unless otherwise demonstrated.’’. 

3 SEC. 5. FUND TO STRENGTHEN EFFORTS OF FDA TO COM4 BAT THE OPIOID AND SUBSTANCE USE EPI5 DEMIC. 

6 Chapter X of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

8 end the following: 

9 ‘‘SEC. 1015. FUND TO STRENGTHEN EFFORTS OF FDA TO 

10 COMBAT THE OPIOID AND SUBSTANCE USE 

11 EPIDEMIC. 

12 ‘‘(a) IN GENERAL.—The Commissioner of Food and 

13 Drugs shall use any funds appropriated pursuant to the 

14 authorization of appropriations under subsection (c) to 

15 carry out the programs and activities described in sub16 section (d) to strengthen and facilitate the Food and Drug 

17 Administration’s efforts to address the opioid and sub18 stance use epidemic. Such funds shall be in addition to 

19 any funds which are otherwise available to carry out such 

20 programs and activities. 

21 ‘‘(b) FDA OPIOID AND SUBSTANCE USE EPIDEMIC

22 RESPONSE FUND.— 

23 ‘‘(1) ESTABLISHMENT OF FUND.—There is es24 tablished in the Treasury a fund, to be known as the 

25 FDA Opioid and Substance Use Epidemic Response 


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1 Fund (referred to in this subsection as the ‘Fund’), 

2 for purposes of funding the programs and activities 

3 described in subsection (d). 

4 ‘‘(2) TRANSFER.—For the period of fiscal years 

5 2019 through 2023, $110,000,000 shall be trans6 ferred to the Fund from the general fund of the 

7 Treasury. 

8 ‘‘(3) AMOUNTS DEPOSITED.—Any amounts 

9 transferred under paragraph (2) shall remain un10 available in the Fund until such amounts are appro11 priated pursuant to subsection (c). 

12 ‘‘(c) APPROPRIATIONS.— 

13 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.— 

14 For the period of fiscal years 2019 through 2023, 

15 there is authorized to be appropriated from the 

16 Fund to the Food and Drug Administration, for the 

17 purpose of carrying out the programs and activities 

18 described in subsection (d), an amount not to exceed 

19 the total amount transferred to the Fund under sub20 section (b)(2). Notwithstanding subsection (g), such 

21 funds shall remain available until expended. 

22 ‘‘(2) OFFSETTING FUTURE APPROPRIATIONS.— 

23 For any of fiscal years 2019 through 2023, for any 

24 discretionary appropriation out of the Fund to the 

25 Food and Drug Administration pursuant to the auVerDate Sep 11 2014 00:08 Jun 14, 2018 Jkt 079200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5228.RFS H5228

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1 thorization of appropriations under paragraph (1) 

2 for the purpose of carrying out the programs and 

3 activities described in subsection (d), the total 

4 amount of such appropriations for the applicable fis5 cal year (not to exceed the total amount remaining 

6 in the Fund) shall be subtracted from the estimate 

7 of discretionary budget authority and the resulting 

8 outlays for any estimate under the Congressional 

9 Budget and Impoundment Control Act of 1974 or 

10 the Balanced Budget and Emergency Deficit Control 

11 Act of 1985, and the amount transferred to the 

12 Fund shall be reduced by the same amount. 

13 ‘‘(d) FOOD AND DRUG ADMINISTRATION.—The en14 tirety of the funds made available pursuant to subsection 

15 (c)(1) shall be for the Commissioner of Food and Drugs, 

16 pursuant to applicable authorities in the Public Health 

17 Service Act (42 U.S.C. 201 et seq.) or this Act and other 

18 applicable Federal law, to support widespread innovation 

19 in non-opioid and non-addictive medical products for pain 

20 treatment, access to opioid addiction treatments, appro21 priate use of approved opioids, and efforts to reduce illicit 

22 importation of opioids. Such support may include the fol23 lowing programs and activities: 


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1 ‘‘(1) Obligating contract funds beginning in fis2 cal year 2019 for an educational campaign that 

3 will— 

4 ‘‘(A) educate patients and their families to 

5 differentiate opioid medications; 

6 ‘‘(B) raise awareness about preferred stor7 age and disposal methods; and 

8 ‘‘(C) inform patients, families, and commu9 nities about medication-assisted treatment op10 tions. 

11 ‘‘(2) Building the Food and Drug Administra12 tion’s presence in international mail facilities, includ13 ing through— 

14 ‘‘(A) improvements in equipment and in15 formation technology enhancements to identify 

16 unapproved, counterfeit, or other unlawful 

17 pharmaceuticals for destruction; 

18 ‘‘(B) increased and improved surveillance; 

19 ‘‘(C) renovations at international mail fa20 cility locations; and 

21 ‘‘(D) the purchase of laboratory equip22 ment. 

23 ‘‘(3) Enhancing the identification and targeting 

24 of entities offering products and products being of25 fered by such entities for import into the United 


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1 States through review and analysis of Internet 

2 websites, import data, and other sources of intel3 ligence for purposes of making the best use of the 

4 Food and Drug Administration’s inspection and ana5 lytical resources. 

6 ‘‘(4) Increasing the number of staff of the Food 

7 and Drug Administration to increase the number of 

8 packages being examined, ensuring the safety of the 

9 staff undertaking such examinations, and ensuring 

10 that packages identified as illegal, counterfeit, mis11 branded, or adulterated are removed from commerce 

12 through available authorities, including administra13 tive destruction. 

14 ‘‘(5) Enhancing the Food and Drug Adminis15 tration’s criminal investigations resources (including 

16 full-time equivalent employees and equipment), im17 ports surveillance, and international work. 

18 ‘‘(6) Obtaining for the Food and Drug Admin19 istration equipment and full-time equivalent employ20 ees needed to efficiently screen and analyze products 

21 offered for import, including by building data librar22 ies of new substances and analogues to facilitate 

23 identification and evaluation of pharmaceutical24 based agents and by purchasing screening tech25 nologies for use at international mail facilities. 


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1 ‘‘(7) Operating the Food and Drug Administra2 tion’s forensic laboratory facility to ensure adequate 

3 laboratory space and functionality for additional 

4 work and full-time equivalent employees. 

5 ‘‘(e) ACCOUNTABILITY AND OVERSIGHT.— 

6 ‘‘(1) WORK PLAN.— 

7 ‘‘(A) IN GENERAL.—Not later than 180 

8 days after the date of enactment of this Act, 

9 the Commissioner of Food and Drugs shall sub10 mit to the Committee on Health, Education, 

11 Labor and Pensions of the Senate and the 

12 Committee on Energy and Commerce of the 

13 House of Representatives, a work plan includ14 ing the proposed allocation of funds appro15 priated pursuant to the authorization of appro16 priations under subsection (c) for each of fiscal 

17 years 2019 through 2023 and the contents de18 scribed in subparagraph (B). 

19 ‘‘(B) CONTENTS.—The work plan sub20 mitted under subparagraph (A) shall include— 

21 ‘‘(i) the amount of money to be obli22 gated or expended out of the Fund in each 

23 fiscal year for each program and activity 

24 described in subsection (d); and 


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1 ‘‘(ii) a description and justification of 

2 each such program and activity. 

3 ‘‘(2) REPORTS.— 

4 ‘‘(A) ANNUAL REPORTS.—Not later than 

5 October 1 of each of fiscal years 2020 through 

6 2024, the Secretary of Health and Human 

7 Services shall submit to the Committee on 

8 Health, Education, Labor and Pensions of the 

9 Senate and the Committee on Energy and Com10 merce of the House of Representatives a report 

11 that includes— 

12 ‘‘(i) the amount of money obligated or 

13 expended out of the Fund in the prior fis14 cal year for each program and activity de15 scribed in subsection (d); 

16 ‘‘(ii) a description of all programs and 

17 activities using funds provided pursuant to 

18 the authorization of appropriations under 

19 subsection (c); and 

20 ‘‘(iii) how the programs and activities 

21 are advancing public health. 

22 ‘‘(B) ADDITIONAL REPORTS.—At the re23 quest of the Committee on Health, Education, 

24 Labor and Pensions of the Senate or the Com25 mittee on Energy and Commerce of the House 


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1 of Representatives, the Commissioner shall pro2 vide an update in the form of testimony and 

3 any additional reports to the respective congres4 sional committee regarding the allocation of 

5 funding under this section or the description of 

6 the programs and activities undertaken with 

7 such funding. 

8 ‘‘(f) LIMITATIONS.—Notwithstanding any transfer 

9 authority authorized by this section or any appropriations 

10 Act, any funds made available pursuant to the authoriza11 tion of appropriations under subsection (c) may not be 

12 used for any purpose other than the programs and activi13 ties described in subsection (d) to strengthen and facilitate 

14 the Food and Drug Administration’s efforts to address the 

15 opioid and substance use epidemic. 

16 ‘‘(g) SUNSET.—This section shall expire on Sep17 tember 30, 2022, except that— 

18 ‘‘(1) this subsection does not apply to reporting 

19 under subsection (e)(2); and 

20 ‘‘(2) this section shall remain in effect until 

21 such time, and to such extent, as may be necessary 

22 for the funds transferred by subsection (b)(2) to be 

23 fully expended.’’. 


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1 SEC. 6. CONSIDERATION OF POTENTIAL FOR MISUSE AND 

2 ABUSE REQUIRED FOR DRUG APPROVAL. 

3 (a) IN GENERAL.—Section 505(d) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is 

5 amended— 

6 (1) in the first sentence— 

7 (A) by striking ‘‘or (7)’’ and inserting 

8 ‘‘(7)’’; and 

9 (B) by inserting ‘‘or (8) if the drug is or 

10 contains a controlled substance for which a list11 ing in any schedule is in effect under the Con12 trolled Substances Act or that is permanently 

13 scheduled pursuant to section 201 of such Act, 

14 on the basis of information submitted to him as 

15 part of the application, or upon the basis of any 

16 other information before him with respect to 

17 such drug, the drug is unsafe for use due to the 

18 risks of abuse or misuse or there is insufficient 

19 information to show that the drug is safe for 

20 use considering such risks;’’ before ‘‘he shall 

21 issue an order refusing to approve the applica22 tion’’; and 

23 (2) in the second sentence, by striking ‘‘(6)’’ 

24 and inserting ‘‘(8)’’. 


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1 (b) WITHDRAWAL AUTHORITY.—Section 505(e) of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 355(e)) is amended in the first sentence— 

4 (1) by striking ‘‘or (5)’’ and inserting ‘‘(5)’’; 

5 and 

6 (2) by inserting the following: ‘‘; or (6) that, in 

7 the case of a drug that is or contains a controlled 

8 substance for which a listing in any schedule is in 

9 effect under the Controlled Substances Act or that 

10 is permanently scheduled pursuant to section 201 of 

11 such Act, on the basis of new information before him 

12 with respect to such drug, evaluated together with 

13 the information available to him when the applica14 tion was approved, that the drug is unsafe for use 

15 due to the risks of abuse or misuse’’ after ‘‘of a ma16 terial fact’’. 

17 (c) RULE OF CONSTRUCTION.—Nothing in the 

18 amendments made by this section shall be construed to 

19 limit or narrow, in any manner, the meaning or applica20 tion of the provisions of paragraphs (1), (2), (3), (4), (5), 

21 and (7) of section 505(d) of the Federal Food, Drug, and 


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1 Cosmetic Act (21 U.S.C. 355(d)) or paragraphs (1) and 

2 (2) of section 505(e) of such Act (21 U.S.C. 355(e)). 

Passed the House of Representatives June 12, 2018. 

Attest: KAREN L. HAAS, 

Clerk. 


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