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 reformu-
lated 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 re-
ferred 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Act to Ban Zohydro’’. 
SEC. 2. FINDINGS. 
Congress finds as follows: 
(1) The drug Zohydro ER is a high-dose 
hydrocone-only opioid narcotic painkiller listed in 
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schedule II of section 202(c) of the Controlled Sub-
stances Act (21 U.S.C. 812(c)). 
(2) The Food and Drug Administration Analge-
sic Drug Products Advisory Committee report cited 
available dosages of Zohydro ER that, according to 
health care and substance abuse professionals, have 
up to 10 times more hydrocodone than any 
hydrocodone painkiller currently on the market. 
(3) Zohydro ER is manufactured without an 
abuse deterrent formulation. 
(4) Zohydro’s time-released effect, an important 
element of its pharmaceutical use, is easily negated 
by abusers to achieve a heroin-like effect. 
(5) The Analgesic Drug Products Advisory 
Committee concluded that, if approved and mar-
keted, Zohydro ER will be abused, possibly at a rate 
greater than that of currently available hydrocodone 
combination products. 
(6) The Anesthetic and Analgesic Drug Prod-
ucts Advisory Committee voted 11 to 2 against ap-
proval of Zohydro ER, citing the high possibility for 
addiction. 
(7) The Food and Drug Administration ap-
proved Zohydro ER without an abuse deterrent for-
mulation despite the fact that the Anesthetic and 
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Analgesic Drug Products Advisory Committee voted 
11 to 2 against doing so. 
(8) The Food and Drug Administration has ac-
knowledged that the widespread abuse of opioid 
drugs across the country has reached epidemic pro-
portions in some parts of the country. 
(9) According to the Centers for Disease Con-
trol and Prevention, deaths connected to prescription 
opioids have more than quadrupled in the United 
States, from 4,030 deaths involving the painkillers 
in 1999 to 16,651 deaths in 2010. 
(10) The Centers for Disease Control and Pre-
vention has identified reducing deaths attributable to 
prescription painkiller abuse and overdose as a top 
health priority for 2014. 
(11) Attorneys General from 28 States have 
asked the Food and Drug Administration to recon-
sider its approval of Zohydro ER. 
(12) Health care professionals, addiction treat-
ment providers, and community-based drug and al-
cohol prevention programs are groups opposed to the 
approval of Zohydro ER. 
(13) The burdens of Zohydro ER to the public 
health outweigh its potential therapeutic benefits. 
Given that alternative pain medicines and methods 
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are widely available, approval of Zohydro ER should 
be withdrawn until such time that there is available 
a Food and Drug Administration-approved abuse de-
terrent formulation. 
SEC. 3. WITHDRAWAL OF APPROVAL OF DRUG ZOHYDRO 
ER. 
(a) WITHDRAWAL OF APPROVAL.—Effective begin-
ning on the day that is 45 days after the date of enact-
ment of this Act, approval of the application with respect 
to pure hydrocodone bitartrate extended-release capsules 
(marketed as the drug Zohydro ER) under section 505(c) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)) is deemed to have been withdrawn under section 
505(e) of such Act (21 U.S.C. 355(e)). 
(b) NO APPROVAL OF ANY FORMULATION THAT IS 
NOT ABUSE DETERRENT.—The Commissioner of Food 
and Drugs shall not approve any application under section 
505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) for pure hydrocodone bitartrate extended-re-
lease capsules unless such drug is formulated to prevent 
abuse. 
Æ 
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