I 

113TH CONGRESS 

2D SESSION H. R. 4241 

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 HOUSE OF REPRESENTATIVES 

MARCH 13, 2014 

Mr. LYNCH (for himself, Mr. ROGERS of Kentucky, Mr. GRIMM, Ms. 

DELAURO, Mr. KEATING, Mr. WOLF, Mr. FITZPATRICK, Mr. MICHAUD, 

Ms. SHEA-PORTER, Mr. KENNEDY, Mr. TONKO, Mr. HIGGINS, and Ms. 

CLARK of Massachusetts) introduced the following bill; which was referred to the Committee on Energy and Commerce 

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 Analge4 sic Drug Products Advisory Committee report cited 

5 available dosages of Zohydro ER that, according to 

6 health care and substance abuse professionals, have 

7 up to 10 times more hydrocodone than any 

8 hydrocodone painkiller currently on the market. 

9 (3) Zohydro ER is manufactured without an 

10 abuse deterrent formulation. 

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

12 element of its pharmaceutical use, is easily negated 

13 by abusers to achieve a heroin-like effect. 

14 (5) The Analgesic Drug Products Advisory 

15 Committee concluded that, if approved and mar16 keted, Zohydro ER will be abused, possibly at a rate 

17 greater than that of currently available hydrocodone 

18 combination products. 

19 (6) The Anesthetic and Analgesic Drug Prod20 ucts Advisory Committee voted 11 to 2 against ap21 proval of Zohydro ER, citing the high possibility for 

22 addiction. 

23 (7) The Food and Drug Administration ap24 proved Zohydro ER without an abuse deterrent for25 mulation despite the fact that the Anesthetic and 

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1 Analgesic Drug Products Advisory Committee voted 

2 11 to 2 against doing so. 

3 (8) The Food and Drug Administration has ac4 knowledged that the widespread abuse of opioid 

5 drugs across the country has reached epidemic pro6 portions in some parts of the country. 

7 (9) According to the Centers for Disease Con8 trol and Prevention, deaths connected to prescription 

9 opioids have more than quadrupled in the United 

10 States, from 4,030 deaths involving the painkillers 

11 in 1999 to 16,651 deaths in 2010. 

12 (10) The Centers for Disease Control and Pre13 vention has identified reducing deaths attributable to 

14 prescription painkiller abuse and overdose as a top 

15 health priority for 2014. 

16 (11) Attorneys General from 28 States have 

17 asked the Food and Drug Administration to recon18 sider its approval of Zohydro ER. 

19 (12) Health care professionals, addiction treat20 ment providers, and community-based drug and al21 cohol prevention programs are groups opposed to the 

22 approval of Zohydro ER. 

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

24 health outweigh its potential therapeutic benefits. 

25 Given that alternative pain medicines and methods 

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1 are widely available, approval of Zohydro ER should 

2 be withdrawn until such time that there is available 

3 a Food and Drug Administration-approved abuse de4 terrent formulation. 

5 SEC. 3. WITHDRAWAL OF APPROVAL OF DRUG ZOHYDRO 

6 ER. 

7 (a) WITHDRAWAL OF APPROVAL.—Effective begin8 ning on the day that is 45 days after the date of enact9 ment of this Act, approval of the application with respect 

10 to pure hydrocodone bitartrate extended-release capsules 

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

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

13 355(c)) is deemed to have been withdrawn under section 

14 505(e) of such Act (21 U.S.C. 355(e)). 

15 (b) NO APPROVAL OF ANY FORMULATION THAT IS

16 NOT ABUSE DETERRENT.—The Commissioner of Food 

17 and Drugs shall not approve any application under section 

18 505 of the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 355) for pure hydrocodone bitartrate extended-re20 lease capsules unless such drug is formulated to prevent 

21 abuse. 

Æ 

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