I 

113TH CONGRESS 

2D SESSION H. R. 5874 

To amend the Federal Food, Drug, and Cosmetic Act to increase criminal 

penalties for the sale or trade of prescription drugs knowingly caused 

to be adulterated or misbranded, to establish recall authority regarding 

drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 11, 2014 

Mr. ISRAEL 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 

increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or 

misbranded, to establish recall authority regarding drugs, 

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. 

4 This Act may be cited as ‘‘Tim Fagan’s Law’’ or the 

5 ‘‘Counterfeit Drug Enforcement Act of 2014’’. 


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1 SEC. 2. SALE OR TRADE OF PRESCRIPTION DRUGS KNOW2 INGLY CAUSED TO BE ADULTERATED OR MIS3 BRANDED; MISREPRESENTATION AS AP4 PROVED DRUGS. 

5 (a) CRIMINAL PENALTY.—Section 303(a) of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)) 

7 is amended by adding at the end the following paragraphs: 

8 ‘‘(3) Notwithstanding paragraph (1) or (2), in the 

9 case of a person who violates subsection (a), (b), or (c) 

10 of section 301 with respect to a drug that is subject to 

11 section 503(b)(1)(B), if the person knowingly caused the 

12 drug to be adulterated or misbranded and sells or trades 

13 the drug, or the person purchases or trades for the drug 

14 knowing or having reason to know that the drug was 

15 knowingly caused to be adulterated or misbranded, the 

16 person shall be fined in accordance with title 18, United 

17 States Code, or imprisoned for any term of years or for 

18 life, or both. 

19 ‘‘(4) Notwithstanding paragraph (1) or (2), in the 

20 case of a person who violates section 301(d) with respect 

21 to a drug, if the person caused the drug to be misrepre22 sented as a drug that is subject to section 503(b)(1)(B) 

23 and for which an approved application is in effect under 

24 section 505 and the person sells or trades the drug, or 

25 the person purchases or trades for the drug knowing or 

26 having reason to know that the drug was knowingly 


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1 caused to be so misrepresented, the person shall be fined 

2 in accordance with title 18, United States Code, or impris3 oned for any term of years or for life, or both.’’. 

4 (b) NOTIFICATION OF FOOD AND DRUG ADMINIS5 TRATION BY MANUFACTURERS.—Section 505(k) of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)) 

7 is amended by adding at the end the following paragraph: 

8 ‘‘(6) A manufacturer of a drug that receives or other9 wise becomes aware of information that reasonably sug10 gests that a violation described in paragraph (3) or (4) 

11 of section 303(a) may have occurred with respect to the 

12 drug shall report such information to the Secretary not 

13 later than 48 hours after first receiving or otherwise be14 coming aware of the information.’’. 

15 SEC. 3. USE OF TECHNOLOGIES FOR PREVENTING COUN16 TERFEITING OF DRUGS. 

17 Section 502 of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 352) is amended by adding at the end the 

19 following: 

20 ‘‘(dd) If it is a drug and it is not manufactured in 

21 accordance with any regulations of the Secretary requiring 

22 the use of technologies that the Secretary has determined 

23 are technically feasible and will assist in preventing viola24 tions of this Act to which paragraphs (3) and (4) of sec25 tion 303(a) apply (relating to the knowing adulteration or 


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1 misbranding of drugs and the knowing misrepresentation 

2 of drugs).’’. 

3 SEC. 4. COUNTERFEIT DRUGS; INCREASED FUNDING FOR 

4 INSPECTIONS, EXAMINATIONS, AND INVES5 TIGATIONS. 

6 For the purpose of increasing the capacity of the 

7 Food and Drug Administration to conduct inspections, ex8 aminations, and investigations under the Federal Food, 

9 Drug, and Cosmetic Act with respect to violations de10 scribed in paragraphs (3) and (4) of section 303(a) of such 

11 Act, there is authorized to be appropriated $60,000,000 

12 for each of the fiscal years 2015 through 2018, in addition 

13 to other authorizations of appropriations that are available 

14 for such purpose. 

15 SEC. 5. PUBLIC EDUCATION REGARDING COUNTERFEIT 

16 DRUGS. 

17 (a) IN GENERAL.—The Secretary of Health and 

18 Human Services shall carry out a program to educate the 

19 public and health care professionals on counterfeit drugs, 

20 including techniques to identify drugs as counterfeit. 

21 (b) AUTHORIZATION OF APPROPRIATIONS.—For the 

22 purpose of carrying out subsection (a), there is authorized 

23 to be appropriated $5,000,000 for each of the fiscal years 

24 2015 through 2018, in addition to other authorizations 

25 of appropriations that are available for such purpose. 


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1 SEC. 6. RECALL AUTHORITY REGARDING DRUGS. 

2 Subchapter A of chapter V of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend4 ed by inserting after section 506F the following section: 

5 ‘‘SEC. 506G. RECALL AUTHORITY. 

6 ‘‘(a) ORDER TO CEASE DISTRIBUTION OF DRUG; 

7 NOTIFICATION OF HEALTH PROFESSIONALS.— 

8 ‘‘(1) IN GENERAL.—If the Secretary finds that 

9 a drug intended for human use may constitute a 

10 threat to the public health, the Secretary shall issue 

11 an order requiring the appropriate person (including 

12 the manufacturers, importers, distributors, or retail13 ers of the drug)— 

14 ‘‘(A) to immediately cease distribution of 

15 the drug; and 

16 ‘‘(B) to immediately notify health profes17 sionals of the order and to instruct such profes18 sionals to cease administering, distributing, sell19 ing, or prescribing the drug. 

20 ‘‘(2) INFORMAL HEARING.—An order under 

21 paragraph (1) shall provide the person subject to the 

22 order with an opportunity for an informal hearing, 

23 to be held not later than 10 days after the date of 

24 the issuance of the order, on the actions required by 

25 the order and on whether the order should be 

26 amended to require a recall of the drug involved. If, 


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1 after providing an opportunity for such a hearing, 

2 the Secretary determines that inadequate grounds 

3 exist to support the actions required by the order, 

4 the Secretary shall vacate the order. 

5 ‘‘(b) ORDER TO RECALL DRUG.— 

6 ‘‘(1) IN GENERAL.—If, after providing an op7 portunity for an informal hearing under subsection 

8 (a)(2), the Secretary determines that the order 

9 should be amended to include a recall of the drug 

10 with respect to which the order was issued, the Sec11 retary shall, except as provided in paragraphs (2) 

12 and (3), amend the order to require a recall. The 

13 Secretary shall specify a timetable in which the drug 

14 recall will occur and shall require periodic reports to 

15 the Secretary describing the progress of the recall. 

16 ‘‘(2) CERTAIN ACTIONS.—An amended order 

17 under paragraph (1)— 

18 ‘‘(A) shall not require recall of a drug from 

19 individuals; and 

20 ‘‘(B) shall provide for notice to individuals 

21 subject to the risks associated with the use of 

22 the drug. 

23 ‘‘(3) ASSISTANCE OF HEALTH PROFES24 SIONALS.—In providing the notice required by para25 graph (2)(B), the Secretary may use the assistance 


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1 of health professionals who administered the drug 

2 involved to individuals or prescribed the drug for in3 dividuals. If a significant number of such individuals 

4 cannot be identified, the Secretary shall notify such 

5 individuals pursuant to section 705(b).’’. 

6 SEC. 7. AUTHORITY TO ISSUE SUBPOENAS WITH RESPECT 

7 TO PREVENTING THREATS TO THE PUBLIC 

8 HEALTH. 

9 Section 303 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 333(a)) is amended by adding at the end 

11 the following subsection: 

12 ‘‘(h) The Secretary and the Attorney General shall 

13 develop and implement a procedure through which the 

14 Chief Counsel in the Food and Drug Administration is au15 thorized to issue subpoenas regarding investigations under 

16 this Act of acts or omissions that may constitute a threat 

17 to the public health, including investigations of alleged vio18 lations to which paragraph (3) or (4) of subsection (a) 

19 apply and alleged violations with respect to which the Sec20 retary is considering the use of authorities under section 

21 304.’’. 

Æ 


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