II 

113TH CONGRESS 

2D SESSION S. 2134 

To withdraw approval for the drug Zohydro ER and prohibit the Food 

and Drug Administration from approving such drug unless it is reformulated to prevent abuse. 

IN THE SENATE OF THE UNITED STATES 

MARCH 13, 2014 

Mr. MANCHIN introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To withdraw approval for the drug Zohydro ER and prohibit 

the Food and Drug Administration from approving such 

drug unless it is reformulated to prevent abuse. 

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 the ‘‘Act to Ban Zohydro’’. 

5 SEC. 2. FINDINGS. 

6 Congress finds as follows: 

7 (1) The drug Zohydro ER is a high-dose 

8 hydrocone-only opioid narcotic painkiller listed in 


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1 schedule II of section 202(c) of the Controlled Sub2 stances Act (21 U.S.C. 812(c)). 

3 (2) The Food and Drug Administration Anes4 thetic and Analgesic Drug Products Advisory Com5 mittee report cited available dosages of Zohydro ER 

6 that, according to health care and substance abuse 

7 professionals, have up to 10 times more hydrocodone 

8 than any hydrocodone painkiller currently on the 

9 market. 

10 (3) Zohydro ER is manufactured without an 

11 abuse deterrent formulation. 

12 (4) Zohydro’s time-released effect, an important 

13 element of its pharmaceutical use, is easily negated 

14 by abusers to achieve a heroin-like effect. 

15 (5) The Anesthetic and Analgesic Drug Prod16 ucts Advisory Committee concluded that, if approved 

17 and marketed, Zohydro ER will be abused, possibly 

18 at a rate greater than that of currently available 

19 hydrocodone combination products. 

20 (6) The Anesthetic and Analgesic Drug Prod21 ucts Advisory Committee voted 11 to 2 against ap22 proval of Zohydro ER, citing the high possibility for 

23 addiction. 

24 (7) The Food and Drug Administration ap25 proved Zohydro ER without an abuse deterrent forVerDate Mar 15 2010 00:41 Mar 20, 2014 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2134.IS S2134

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1 mulation despite the fact that the Anesthetic and 

2 Analgesic Drug Products Advisory Committee voted 

3 11 to 2 against doing so. 

4 (8) The Food and Drug Administration has ac5 knowledged that the widespread abuse of opioid 

6 drugs across the country has reached epidemic pro7 portions in some parts of the country. 

8 (9) According to the Centers for Disease Con9 trol and Prevention, deaths connected to prescription 

10 opioids have more than quadrupled in the United 

11 States, from 4,030 deaths involving the painkillers 

12 in 1999 to 16,651 deaths in 2010. 

13 (10) The Centers for Disease Control and Pre14 vention has identified reducing deaths attributable to 

15 prescription painkiller abuse and overdose as a top 

16 health priority for 2014. 

17 (11) Attorneys General from 28 States have 

18 asked the Food and Drug Administration to recon19 sider its approval of Zohydro ER. 

20 (12) Health care professionals, addiction treat21 ment providers, and community-based drug and al22 cohol prevention programs are groups opposed to the 

23 approval of Zohydro ER. 

24 (13) The burdens of Zohydro ER to the public 

25 health outweigh its potential therapeutic benefits. 


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1 Given that alternative pain medicines and methods 

2 are widely available, approval of Zohydro ER should 

3 be withdrawn until such time that there is available 

4 a Food and Drug Administration-approved abuse de5 terrent formulation. 

6 SEC. 3. WITHDRAWAL OF APPROVAL OF DRUG ZOHYDRO 

7 ER. 

8 (a) WITHDRAWAL OF APPROVAL.—Effective begin9 ning on the day that is 45 days after the date of enact10 ment of this Act, approval of the application with respect 

11 to pure hydrocodone bitartrate extended-release capsules 

12 (marketed as the drug Zohydro ER) under section 505(c) 

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

14 355(c)) is deemed to have been withdrawn under section 

15 505(e) of such Act (21 U.S.C. 355(e)). 

16 (b) NO APPROVAL OF ANY FORMULATION THAT IS

17 NOT ABUSE DETERRENT.—The Commissioner of Food 

18 and Drugs shall not approve any application under section 

19 505 of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 355) for pure hydrocodone bitartrate extended-re21 lease capsules unless such drug is formulated to prevent 

22 abuse. 

Æ 


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