I 

115TH CONGRESS 

2D SESSION H. R. 5228 

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. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 8, 2018 

Mr. PALLONE introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

the Budget, 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 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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Stop Counterfeit Drugs by Regulating and Enhancing 

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


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

2 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. Seizure. 

Sec. 5. Single source pattern of shipments of adulterated or misbranded drugs. 

Sec. 6. Debarring violative individuals or companies. 

Sec. 7. Account to strengthen efforts of FDA to combat the opioid and substance use epidemic. 

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

4 DRUGS OFFERED FOR IMPORTATION. 

5 (a) CERTAIN IMPORTED PRODUCTS DEEMED TO BE

6 DRUGS.—Section 201(g) of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 321(g)) is amended by adding 

8 at the end the following: 

9 ‘‘(3) An article being imported or offered for import 

10 is deemed to be a drug if it— 

11 ‘‘(A) is or contains an active ingredient that is 

12 contained within— 

13 ‘‘(i) a drug for which an approval is in ef14 fect under section 505 of this Act; or 

15 ‘‘(ii) biological product for which a license 

16 is in effect under section 351 of the Public 

17 Health Service Act; 

18 ‘‘(B) is or contains an active ingredient that is 

19 contained within a drug or biological product for 

20 which an investigational use exemption is in effect 

21 under section 505(i) of this Act or section 351(a) of 


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1 the Public Health Service Act, for which substantial 

2 clinical investigations have been instituted, and for 

3 which the existence of such investigations has been 

4 made public; or 

5 ‘‘(C) is a chemical analog of a drug or biologi6 cal product described in clause (A) or (B).’’. 

7 (b) ARTICLES OF CONCERN.— 

8 (1) DELIVERY BY TREASURY TO HHS.—The 

9 first sentence of section 801(a) of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 

11 amended by striking ‘‘and cosmetics’’ and inserting 

12 ‘‘cosmetics, and potential articles of concern (as de13 fined in subsection (t)), and controlled substances 

14 described paragraph (6) in the third sentence of this 

15 subsection’’. 

16 (2) REPEAL OF ANTIQUATED REVIEW PROC17 ESS.— 

18 (A) REPEAL.—The second sentence of sec19 tion 801(a) of the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 381(a)) is repealed. 

21 (B) TECHNICAL CHANGE TO KEEP NUM22 BERING OF SENTENCES THE SAME.—The first 

23 sentence of section 801(a) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 

25 amended by striking ‘‘the owner or consignee, 


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1 who may appear’’ and inserting ‘‘the owner or 

2 consignee. The owner or consignee may ap3 pear’’. 

4 (3) REFUSED ADMISSION.— 

5 (A) IN GENERAL.—The third sentence of 

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

7 Cosmetic Act (21 U.S.C. 381(a)) is amended— 

8 (i) by striking ‘‘If it appears from the 

9 examination’’ and inserting ‘‘Subject to 

10 subsection (b), if it appears from the ex11 amination’’; and 

12 (ii) by striking ‘‘then such article shall 

13 be refused admission, except as provided in 

14 subsection (b) of this section’’ and insert15 ing ‘‘or (5) such article is an article of con16 cern (as defined in subsection (t)), or (6) 

17 such article is a controlled substance (as 

18 defined in section 102 of the Controlled 

19 Substances Act) for which a listing in any 

20 schedule is in effect (on a temporary or 

21 permanent basis) under section 201 of the 

22 Controlled Substances Act, or (7) such ar23 ticle is being imported or offered for im24 port in violation of section 301(cc), then 

25 such article may be refused admission, and 


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1 if it appears such article may not be im2 ported into the United States pursuant to 

3 subsection (d) or it appears that the article 

4 is a counterfeit drug, then such article 

5 shall be refused admission’’. 

6 (B) DEFINITION OF ARTICLE OF CON7 CERN.—Section 801 of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 381) is amended 

9 by adding at the end the following: 

10 ‘‘(t) ARTICLE OF CONCERN DEFINED.—For purposes 

11 of subsection (a), the term ‘article of concern’ means an 

12 article that is or contains a drug or other substance— 

13 ‘‘(1) for which, during the 24-month period 

14 prior to the article being imported or offered for im15 port, the Secretary of Health and Human Services— 

16 ‘‘(A) has requested that, based on a deter17 mination that the drug or other substance ap18 pears to meet the requirements for temporary 

19 or permanent scheduling pursuant to section 

20 201 of the Controlled Substances Act, the At21 torney General initiate the process to control 

22 the drug or other substance in accordance with 

23 such Act; or 

24 ‘‘(B) has made a determination, following 

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1 tice in the Federal Register of the intention to 

2 issue an order temporarily or permanently 

3 scheduling such drug or substance in schedule 

4 I of section 202 of the Controlled Substances 

5 Act, that such article presents an imminent risk 

6 to the public health; and 

7 ‘‘(2) with respect to which the Attorney General 

8 has not— 

9 ‘‘(A) scheduled the drug or other substance 

10 under section 201 of such Act; or 

11 ‘‘(B) notified the Secretary of Health and 

12 Human Services that the Attorney General has 

13 made a determination not to schedule the drug 

14 or other substance under such section.’’. 

15 (c) INCREASING THE MAXIMUM DOLLAR AMOUNT OF

16 DRUGS SUBJECT TO DESTRUCTION.—The sixth sentence 

17 in section 801(a) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 381(a)) is amended by striking ‘‘ex19 cept that the Secretary’’ and all that follows through the 

20 two periods at the end and inserting ‘‘except that the Sec21 retary of Health and Human Services may destroy, with22 out the opportunity for export, any drug refused admission 

23 under this section, if such drug is valued at an amount 

24 that is $2,500 or less (or such higher amount as the Sec25 retary of the Treasury may set by regulation pursuant to 


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1 section 498(a)(1) of the Tariff Act of 1930 or such higher 

2 amount as the Commissioner of Food and Drugs may set 

3 based on a finding by the Commissioner that the higher 

4 amount is in the interest of public health) and was not 

5 brought into compliance as described under subsection 

6 (b).’’. 

7 (d) DESTRUCTION OF ARTICLES OF CONCERN.—The 

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

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

10 by subsection (c), is further amended by inserting before 

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

12 of Health and Human Services may destroy, without the 

13 opportunity for export, any article refused admission 

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

15 (e) TECHNICAL AMENDMENTS.—The seventh, eighth, 

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

17 Drug, and Cosmetic Act (21 U.S.C. 381(a)) are amend18 ed— 

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

20 and inserting ‘‘an article’’; and 

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

22 and inserting ‘‘the article’’. 

23 (f) RULE OF CONSTRUCTION.—The last sentence in 

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

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


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

2 subsection shall not be construed to prohibit the admission 

3 of narcotic or nonnarcotic drugs or other substances, the 

4 importation of which is permitted under the Controlled 

5 Substances Import and Export Act.’’. 

6 SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

7 OF ADULTERATED OR MISBRANDED DRUG 

8 PRODUCTS. 

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

10 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend11 ed by adding at the end the following: 

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

13 under section 569D.’’. 

14 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

15 OF ADULTERATED OR MISBRANDED DRUGS.—Subchapter 

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

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

18 the end the following: 

19 ‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RE20 CALL OF ADULTERATED OR MISBRANDED 

21 DRUGS. 

22 ‘‘(a) ORDER TO CEASE DISTRIBUTION.— 

23 ‘‘(1) IN GENERAL.—If the Secretary has reason 

24 to believe that the use or consumption of, or expo25 sure to, a drug may cause serious adverse health 


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1 consequences or death to humans, the Secretary may 

2 issue an order requiring any person who distributes 

3 such drug to immediately cease distribution of such 

4 drug. 

5 ‘‘(2) ACTION FOLLOWING ORDER.—Any person 

6 who is subject to an order under paragraph (1) shall 

7 immediately cease distribution of such drug and pro8 vide notification as required by such order, and may 

9 appeal to the Secretary within 24 hours of the 

10 issuance of such order. Such appeal may include a 

11 request for an informal hearing and a description of 

12 any efforts to recall such drug undertaken volun13 tarily by the person, including after a request under 

14 subsection (b). Except as provided in subsection (c), 

15 an informal hearing shall be held as soon as prac16 ticable, but not later than 5 calendar days, or less 

17 as determined by the Secretary, after such an appeal 

18 is filed, unless the parties jointly agree to an exten19 sion. After affording an opportunity for an informal 

20 hearing, the Secretary shall determine whether the 

21 order should be amended to require a recall of such 

22 drug. If, after providing an opportunity for such a 

23 hearing, the Secretary determines that inadequate 

24 grounds exist to support the actions required by the 

25 order, the Secretary shall vacate the order. 


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1 ‘‘(b) EMERGENCY RECALL ORDER.— 

2 ‘‘(1) IN GENERAL.—If the Secretary has cred3 ible evidence or information that a drug subject to 

4 an order under subsection (a) presents an imminent 

5 threat of serious adverse health consequences or 

6 death to humans, the Secretary may issue an order 

7 requiring any person who distributes such drug— 

8 ‘‘(A) to immediately recall such drug; and 

9 ‘‘(B) to provide for notice, including to in10 dividuals as appropriate, to persons who may be 

11 affected by the recall. 

12 ‘‘(2) ACTION FOLLOWING ORDER.—Any person 

13 who is subject to an emergency recall order under 

14 this subsection shall immediately recall such drug 

15 and provide notification as required by such order, 

16 and may appeal to the Secretary within 24 hours 

17 after issuance of such order. The person subject to 

18 an emergency recall order shall conduct the recall 

19 notwithstanding the pendency of any such appeal. 

20 An informal hearing shall be held as soon as prac21 ticable but not later than 5 calendar days, or less as 

22 determined by the Secretary, after such an appeal is 

23 filed, unless the parties jointly agree to an extension. 

24 After affording an opportunity for an informal hear25 ing, the Secretary shall determine whether the order 


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1 should be amended pursuant to subsection (d)(1). If, 

2 after providing an opportunity for such a hearing, 

3 the Secretary determines that inadequate grounds 

4 exist to support the actions required by the order, 

5 the Secretary shall vacate the order. 

6 ‘‘(c) NOTICE TO CONSUMERS AND HEALTH OFFI7 CIALS.—The Secretary shall, as the Secretary determines 

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

9 section to— 

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

11 have been, distributed; and 

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

13 ‘‘(d) ORDER TO RECALL.— 

14 ‘‘(1) AMENDMENT.—Except as provided under 

15 subsection (e), if after providing an opportunity for 

16 an informal hearing under subsection (a) or (b), the 

17 Secretary determines that an order issued under 

18 subsection (a) or (b) should be amended to include 

19 a recall of the drug with respect to which the order 

20 was issued, the Secretary shall amend the order to 

21 require a recall. 

22 ‘‘(2) CONTENTS.—An amended order under 

23 paragraph (1) shall— 

24 ‘‘(A) specify a timetable in which the recall 

25 will occur; 


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

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

5 affected by the recall. 

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

7 notice under paragraph (2)(C), 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 ‘‘(4) NONDELEGATION.—An amended order 

12 under this subsection shall be ordered by the Sec13 retary or an official designated by the Secretary. An 

14 official may not be so designated under this section 

15 unless the official is the director of the district in 

16 which the drug involved is located, or is an official 

17 senior to such director. 

18 ‘‘(e) 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), as amended by 

6 section 2(b)(C), is further amended by inserting ‘‘or (8) 

7 in the case of a drug, such drug is subject to an order 

8 under section 568 to cease distribution of or recall the 

9 drug,’’ before ‘‘then such article shall be refused admis10 sion’’. 

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

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

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

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

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

16 Human Services shall specify. 

17 SEC. 4. SEIZURE. 

18 Section 304(b) of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 334(b)) is amended by striking the 

20 first sentence and inserting the following: ‘‘The article, 

21 equipment, or other thing proceeded against shall be liable 

22 to seizure by process pursuant to the libel, and the proce23 dure in cases under this section shall conform, as nearly 

24 as may be, to the procedure in admiralty rather than the 

25 procedure used for civil asset forfeiture proceedings set 


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1 forth in section 983 of title 18, United States Code. On 

2 demand of either party any issue of fact joined in any such 

3 a case brought under this section shall be tried by jury. 

4 A seizure brought under this section is not governed by 

5 Rule G of the Supplemental Rules of Admiralty or Mari6 time Claims and Asset Forfeiture Actions. Exigent cir7 cumstances shall be deemed to exist for all seizures 

8 brought under this section, and in such cases, the sum9 mons and arrest warrant shall be issued by the clerk of 

10 the court without court review.’’. 

11 SEC. 5. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADUL12 TERATED OR MISBRANDED DRUGS. 

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

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

15 ‘‘(u) SINGLE SOURCE PATTERN OF SHIPMENTS OF

16 ADULTERATED OR MISBRANDED DRUGS.—If the Sec17 retary identifies a pattern of adulterated or misbranded 

18 drugs being offered for import from the same manufac19 turer, distributor, or importer, the Secretary may by order 

20 choose to treat all drugs being offered for import from 

21 such manufacturer, distributor, or importer as adulterated 

22 or misbranded unless otherwise demonstrated.’’. 


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1 SEC. 6. DEBARRING VIOLATIVE INDIVIDUALS OR COMPA2 NIES. 

3 (a) PROHIBITED ACT.—Section 301(cc) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 

5 is amended to read as follows: 

6 ‘‘(cc) The importing or offering for import into the 

7 United States of an article by, with the assistance of, or 

8 at the direction of, a person debarred from such activity 

9 under section 306(b)(3).’’. 

10 (b) DEBARMENT.—Section 306(b) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 

12 amended— 

13 (1) in paragraph (1)— 

14 (A) in the matter preceding subparagraph 

15 (A), by striking ‘‘paragraph (2)’’ and inserting 

16 ‘‘paragraph (2) or (3)’’; 

17 (B) in subparagraph (B), by striking ‘‘or’’ 

18 at the end; 

19 (C) in subparagraph (C), by striking the 

20 period at the end and inserting ‘‘, or’’; and 

21 (D) by adding at the end the following: 

22 ‘‘(D) a person from importing or offering 

23 to import into the United States— 

24 ‘‘(i) a controlled substance as defined 

25 in section 102(6) of the Controlled Sub26 stances Act; or 


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1 ‘‘(ii) any article that is regulated by 

2 the Food and Drug Administration that is 

3 valued at $2500 or less (or such higher 

4 amount as the Secretary of the Treasury 

5 may set by regulation pursuant to section 

6 498(a)(1) of the Tariff Act of 1930).’’; and 

7 (2) by striking paragraph (3) and inserting the 

8 following: 

9 ‘‘(3) PERSONS SUBJECT TO PERMISSIVE DE10 BARMENT; IMPORTATION.— 

11 ‘‘(A) FOOD.—A person is subject to debar12 ment under paragraph (1)(C) if— 

13 ‘‘(i) the person has been convicted of 

14 a felony for conduct relating to the impor15 tation into the United States of any food; 

16 or 

17 ‘‘(ii) the person has engaged in a pat18 tern of importing or offering for import 

19 adulterated food that presents a threat of 

20 serious adverse health consequences or 

21 death to humans or animals. 

22 ‘‘(B) IMPORTATION OF DRUGS.—A person 

23 is subject to debarment under paragraph (1)(D) 

24 if— 


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1 ‘‘(i) the person has been convicted of 

2 a felony for conduct relating to the impor3 tation into the United States of any drug 

4 or controlled substance (as defined in sec5 tion 102 of the Controlled Substances 

6 Act); or 

7 ‘‘(ii) the person has engaged in a pat8 tern of importing or offering for import 

9 drugs that are— 

10 ‘‘(I) adulterated, misbranded, or 

11 in violation of section 505; or 

12 ‘‘(II) controlled substances whose 

13 importation is prohibited pursuant to 

14 section 401(m) of the Tariff Act of 

15 1930.’’. 

16 SEC. 7. ACCOUNT TO STRENGTHEN EFFORTS OF FDA TO 

17 COMBAT THE OPIOID AND SUBSTANCE USE 

18 EPIDEMIC. 

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

20 Drugs (referred to in this section as the ‘‘Commissioner’’) 

21 shall use any funds appropriated pursuant to the author22 ization of appropriations under subsection (c) to carry out 

23 the programs and activities described in subsection (d) to 

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1 demic. Such funds shall be in addition to any funds which 

2 are otherwise available to carry out such programs and 

3 activities. 

4 (b) FDA OPIOID AND SUBSTANCE USE EPIDEMIC

5 RESPONSE FUND.— 

6 (1) ESTABLISHMENT OF FUND.—There is es7 tablished in the Treasury an account, to be known 

8 as the FDA Opioid and Substance Use Epidemic 

9 Response Fund (referred to in this subsection as the 

10 ‘‘Fund’’), for purposes of funding the programs and 

11 activities described in subsection (d). 

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

13 2019 through 2023, $110,000,000 shall be trans14 ferred to the Fund from the general fund of the 

15 Treasury. 

16 (3) AMOUNTS DEPOSITED.—Any amounts 

17 transferred under paragraph (2) shall remain un18 available in the Fund until such amounts are appro19 priated pursuant to subsection (c). 

20 (c) APPROPRIATIONS.— 

21 (1) AUTHORIZATION OF APPROPRIATIONS.—For 

22 the period of fiscal years 2019 through 2023, there 

23 is authorized to be appropriated from the Account to 

24 the Food and Drug Administration, for the purpose 

25 of carrying out the programs and activities described 


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1 in subsection (d), an amount not to exceed the total 

2 amount transferred to the Account under subsection 

3 (b)(2). Notwithstanding subsection (g), such funds 

4 shall remain available until expended. 

5 (2) OFFSETTING FUTURE APPROPRIATIONS.— 

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

7 discretionary appropriation out of the Account to the 

8 Food and Drug Administration pursuant to the au9 thorization of appropriations under paragraph (1) 

10 for the purpose of carrying out the programs and 

11 activities described in subsection (d), the total 

12 amount of such appropriations for the applicable fis13 cal year (not to exceed the total amount remaining 

14 in the Account) shall be subtracted from the esti15 mate of discretionary budget authority and the re16 sulting outlays for any estimate under the Congres17 sional Budget and Impoundment Control Act of 

18 1974 or the Balanced Budget and Emergency Def19 icit Control Act of 1985, and the amount transferred 

20 to the Account shall be reduced by the same 

21 amount. 

22 (d) FOOD AND DRUG ADMINISTRATION.—The en23 tirety of the funds made available pursuant to subsection 

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

25 pursuant to applicable authorities in the Public Health 


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1 Service Act (42 U.S.C. 201 et seq.) or the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other 

3 applicable law, to support widespread innovation in non4 opioid and non-addictive medical products for pain treat5 ment, access to opioid addiction treatments, appropriate 

6 use of approved opioids, and efforts to reduce illicit impor7 tation of opioids. Such support may include the following 

8 programs and activities: 

9 (1) Obligating contract funds beginning in fis10 cal year 2019 for an educational campaign that 

11 will— 

12 (A) educate patients and their families to 

13 differentiate opioid medications; 

14 (B) raise awareness about preferred stor15 age and disposal methods; and 

16 (C) inform patients, families, and commu17 nities about medication-assisted treatment op18 tions. 

19 (2) Building the Food and Drug Administra20 tion’s presence in international mail facilities, includ21 ing through— 

22 (A) improvements in equipment and infor23 mation technology enhancements to identify un24 approved, counterfeit, or other unlawful phar25 maceuticals for destruction; 


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1 (B) increased and improved surveillance; 

2 (C) renovations at international mail facil3 ity locations; and 

4 (D) the purchase of laboratory equipment. 

5 (3) Enhancing the identification and targeting 

6 of firms and products being offered for import into 

7 the United States through review and analysis of 

8 websites, imports data, and other sources of intel9 ligence thereby making best use of the Food and 

10 Drug Administration’s inspectional and analytical 

11 resources. 

12 (4) Increasing the number of staff to increase 

13 the number of packages being examined, ensuring 

14 the safety of the staff undertaking this work, and 

15 ensuring that packages identified as illegal, counter16 feit, misbranded, or adulterated are removed from 

17 commerce through available authorities, including 

18 administrative destruction. 

19 (5) Enhancing criminal investigations resources 

20 (including full-time equivalent employees and equip21 ment), imports surveillance, and international work. 

22 (6) Obtaining equipment and full-time equiva23 lent employees needed to efficiently screen and ana24 lyze products offered for import, including by build25 ing data libraries of new substances and analogues 


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1 to facilitate identification and evaluation of pharma2 ceutical-based agents and by purchasing screening 

3 technologies for use at international mail facilities. 

4 (7) Operating the Food and Drug Administra5 tion’s forensic laboratory facility to ensure adequate 

6 laboratory space and functionality for additional 

7 work and full-time equivalent employees. 

8 (e) ACCOUNTABILITY AND OVERSIGHT.— 

9 (1) WORK PLAN.— 

10 (A) IN GENERAL.—Not later than 180 

11 days after the date of enactment of this Act, 

12 the Commissioner of Food and Drugs shall sub13 mit to the Committee on Health, Education, 

14 Labor, and Pensions of the Senate and the 

15 Committee on Energy and Commerce of the 

16 House of Representatives, a work plan includ17 ing the proposed allocation of funds appro18 priated pursuant to the authorization of appro19 priations under subsection (c) for each of fiscal 

20 years 2019 through 2023 and the contents de21 scribed in subparagraph (B). 

22 (B) CONTENTS.—The work plan submitted 

23 under subparagraph (A) shall include— 

24 (i) the amount of money to be obli25 gated or expended out of the Account in 


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1 each fiscal year for each program and ac2 tivity described in subsection (d); and 

3 (ii) a description and justification of 

4 each such program and activity. 

5 (2) REPORTS.— 

6 (A) ANNUAL REPORTS.—Not later than 

7 October 1 of each of fiscal years 2020 through 

8 2024, the Secretary of Health and Human 

9 Services shall submit to the Committee on 

10 Health, Education, Labor, and Pensions of the 

11 Senate and the Committee on Energy and Com12 merce of the House of Representatives, a report 

13 including— 

14 (i) the amount of money obligated or 

15 expended out of the Account in the prior 

16 fiscal year for each program and activity 

17 described in subsection (d); 

18 (ii) a description of all programs and 

19 activities using funds provided pursuant to 

20 the authorization of appropriations under 

21 subsection (c); and 

22 (iii) how the programs and activities 

23 are advancing public health. 

24 (B) ADDITIONAL REPORTS.—At the re25 quest of the Committee on Health, Education, 


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1 Labor, and Pensions of the Senate, or the Com2 mittee on Energy and Commerce of the House 

3 of Representatives, the Commissioner shall pro4 vide an update in the form of testimony and 

5 any additional reports to the respective congres6 sional committee regarding the allocation of 

7 funding under this section or the description of 

8 the programs and activities undertaken with 

9 such funding. 

10 (f) LIMITATIONS.—Notwithstanding any transfer au11 thority authorized by this Act or any appropriations Act, 

12 any funds made available pursuant to the authorization 

13 of appropriations under subsection (c) may not be used 

14 for any purpose other than the programs and activities 

15 described in subsection (d) strengthen and facilitate the 

16 Food and Drug Administration’s efforts to address the 

17 opioid and substance use epidemic. 

18 (g) SUNSET.—This section shall expire on September 

19 30, 2022, except that— 

20 (1) this subsection does not apply to reporting 

21 under subsection (e)(2); and 

22 (2) this section shall remain in effect until such 

23 time, and to such extent, as may be necessary for 


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1 the funds transferred by subsection (b)(2) to be fully 

2 expended. 

Æ 


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