[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2134 Introduced in Senate (IS)]

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.

    Be it enacted by the Senate and House of Representatives 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 schedule II of section 
        202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).
            (2) The Food and Drug Administration Anesthetic and 
        Analgesic 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 Anesthetic and Analgesic Drug Products Advisory 
        Committee concluded that, if approved and marketed, Zohydro ER 
        will be abused, possibly at a rate greater than that of 
        currently available hydrocodone combination products.
            (6) The Anesthetic and Analgesic Drug Products Advisory 
        Committee voted 11 to 2 against approval of Zohydro ER, citing 
        the high possibility for addiction.
            (7) The Food and Drug Administration approved Zohydro ER 
        without an abuse deterrent formulation despite the fact that 
        the Anesthetic and Analgesic Drug Products Advisory Committee 
        voted 11 to 2 against doing so.
            (8) The Food and Drug Administration has acknowledged that 
        the widespread abuse of opioid drugs across the country has 
        reached epidemic proportions in some parts of the country.
            (9) According to the Centers for Disease Control 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 Prevention 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 reconsider its approval of Zohydro 
        ER.
            (12) Health care professionals, addiction treatment 
        providers, and community-based drug and alcohol 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 are widely available, 
        approval of Zohydro ER should be withdrawn until such time that 
        there is available a Food and Drug Administration-approved 
        abuse deterrent formulation.

SEC. 3. WITHDRAWAL OF APPROVAL OF DRUG ZOHYDRO ER.

    (a) Withdrawal of Approval.--Effective beginning on the day that is 
45 days after the date of enactment 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-release capsules 
unless such drug is formulated to prevent abuse.
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