Bill Text: NJ AR130 | 2014-2015 | Regular Session | Introduced
Bill Title: Urges US FDA to reconsider approval of Zohydro ER pending comprehensive testing.
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Introduced - Dead) 2014-06-05 - Introduced, Referred to Assembly Health and Senior Services Committee [AR130 Detail]
Download: New_Jersey-2014-AR130-Introduced.html
Sponsored by:
Assemblyman JOSEPH A. LAGANA
District 38 (Bergen and Passaic)
Assemblywoman ANGELICA M. JIMENEZ
District 32 (Bergen and Hudson)
SYNOPSIS
Urges US FDA to reconsider approval of Zohydro ER pending comprehensive testing.
CURRENT VERSION OF TEXT
As introduced.
An Assembly Resolution urging the U.S. Food and Drug Administration to reconsider approval of Zohydro ER pending comprehensive testing.
Whereas, In July 2013, the New Jersey State Commission of Investigation (SCI) released a report concluding that drug-related deaths in New Jersey increased by 20 percent from 2010 to 2011, with a 28 percent increase in deaths related to mixed use of heroin and other illicit drugs in New Jersey from 2010 to 2011; and
Whereas, The SCI reported that improper use of prescription medication often leads to abuse of heroin and other illicit drugs, and that heroin is a less expensive way for individuals addicted to prescription medications to abuse drugs; and
Whereas, As further noted by the SCI, the number of individuals admitted to drug addiction treatment centers for opioid pill addictions in New Jersey tripled from 2006 to 2011, with nearly half of the admitted patients in New Jersey in 2011 being age 25 or younger; and
Whereas, According to the Centers for Disease Control and Prevention, nearly half of the nation's 38,329 drug overdose deaths in 2010 involved painkillers such as hydrocodone and oxycodone; and
Whereas, Prescription opioid painkillers now are responsible for the deaths of more adults than heroin and cocaine combined, and deaths across the U.S. from these drugs have quadrupled since 1999; and
Whereas, These prescription painkillers are very easily misused, and according to a 2013 report by the Trust for America's Health, 6.1 million Americans abuse or misuse prescription drugs; and
Whereas, The U.S. Food and Drug Administration (FDA) recently approved a new painkiller, Zohydro ER, a long-acting formulation of the opioid hydrocodone; and
Whereas, The FDA's approval was against the advice of its own advisory panel, which overwhelmingly advised against approval of the drug, and which found critical issues with the results of the clinical trials of Zohydro; and
Whereas, Zohydro ER does not come in an abuse-deterrent form like other opioids on the market and comes in a capsule that can be crushed to be snorted, injected or illegally sold; and
Whereas, Twenty-nine state attorney generals have asked the FDA to reconsider its approval of Zohydro ER; and
Whereas, Nearly four dozen anti-addiction and consumer groups signed a letter to FDA Commissioner, Dr. Margaret A. Hamburg, urging her to overturn the approval of Zohydro ER; and
Whereas, Prescription drug and heroin addiction and abuse have risen to epidemic levels in New Jersey, warranting a swift response to the release of new prescription drugs that may exacerbate the crisis; and
Whereas, It is altogether fitting and proper, and in the public interest, for this House to urge the FDA to reconsider its approval of Zohydro ER pending comprehensive testing; now, therefore,
Be It Resolved by the General Assembly of the State of New Jersey:
1. This House urges the United States Food and Drug Administration to reconsider its approval of Zohydro ER pending comprehensive testing.
2. Copies of this resolution, as filed with the Secretary of State, shall be transmitted by the Secretary of the Senate to the President of the United States and the Commissioner of the Food and Drug Administration.
STATEMENT
This resolution urges the U.S. Food and Drug Administration (FDA) to reconsider its approval of Zohydro ER pending comprehensive testing. Zohydro ER is an extended-release formulation of the opioid hydrocodone. Despite an 11-2 vote by the FDA's advisory panel against approval of the drug, the FDA nevertheless approved Zohydro ER for the market.
The heroin and prescription drug epidemic spanning across the nation, including, but not limited to New Jersey, has caused many states to question whether the risks of Zohydro ER outweigh its benefits. Indeed, 29 state attorney generals have asked the FDA to reconsider its approval. Moreover, numerous consumer and anti-addiction groups have reached out to the FDA Commissioner regarding reconsideration of approval for Zohydro.
The statistics related to heroin and prescription drug abuse are staggering. Nearly half of the nation's 38,329 drug overdose deaths are related to opioid painkillers, and 6.1 million Americans misuse or abuse opioid painkillers every year. Deaths from opioid painkillers have quadrupled since 1999. Moreover, prescription opioids are generally easy to abuse, and individuals who initially take these opioids for legitimate purposes become addicted and try heroin, a cheaper and more potent alternative.
Although the FDA advisory panel's decisions are not binding, it is unclear why the FDA ignored the panel's overwhelming recommendation not to approve Zohydro. In particular, the panel noted many concerns with the clinical trials of Zohydro. Based upon the advisory panel's recommendations and the proliferation of prescription drug and heroin abuse, it is the sponsor's hope that the FDA reconsiders its approval of Zohydro ER pending further comprehensive testing.
