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Zohydro Ban Possible? Senator Introduces Bill To Revoke FDA Approval

Mar 13 2014, 8:31pm CDT | by

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Zohydro Ban Possible? Senator Introduces Bill To Revoke FDA Approval

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Zohydro Ban Possible? Senator Introduces Bill To Revoke FDA Approval

Earlier today, Senator Joe Manchin (D-W.Va.) submitted a bill that, if passed, would force the Food and Drug Administration (FDA) to rescind its approval of the painkiller Zohydro, which a growing coalition of critics believes could become the next Oxycontin in the epidemic of prescription painkiller addiction.

The “Act to Ban Zohydro,” as Manchin called his bill, offers a 13-point argument as to why the drug is simply too dangerous and the FDA’s approval should be overturned.

Why Are Experts Worried About Zohydro?

Zohydro ER is a potent extended release formulation of hydrocodone, the opiate that’s the primary ingredient in Vicodin among other drugs.

The difference is that Zohydro is 10 times as strong as any other hydrocodone-based opiate painkiller available – critics contend that two pills could be fatal to someone without a high tolerance for opiates, and one pill could kill a child. If brought to market, it would be the only drug that uses hydrocodone alone to treat chronic pain.

Among Manchin and colleagues’ main points:

  • Deaths from prescription opioids have quadrupled in 10 years from more than 4,000 in 1999 to 16, 651 in 2010.
  • The FDA itself has announced that death and addiction from prescription painkillers has become a national epidemic.
  • Zohydro’s time-release formula could easily be altered by abusers to achieve a “heroin-like effect.”
  • The FDA’s own advisory committee recommended against approval of Zohydro.
  • The CDC has announced that reducing deaths from painkiller overdose and abuse is a primary goal for 2014.
  • The public burdens that Zohydro would impose “outweigh its therapeutic potential” given that there are numerous other hydrocodone-based painkillers – and other pain medications and pain control methods – available.

In a move with implications for all opiate painkillers currently in development, the bill also calls for blocking approval of similar painkillers unless they are formulated with abuse deterrents.

Two weeks ago, I reported on the growing movement among doctors, lawmakers, addiction specialists, and law enforcement experts calling themselves Fed Up to turn around the FDA’s approval process based on Zohydro’s potential for abuse and addiction. In what I termed a Just Say No to Zohydro campaign, more than 40 experts wrote a letter to FDA Commissioner Margaret Hamburg arguing that the FDA was mistaken in approving Zohydro ER,  the growing epidemic of painkiller addiction.

My story also received an onslaught of comments from chronic pain sufferers arguing that they need Zohydro, and their opinions are worth reading as well.

In the past two weeks, Manchin and Senator Charles Schumer (D.-New York) have called on Health and Human Services chief Kathleen Sibelius in letters to overturn the FDA’s approval.

In Senate hearings today, FDA Commissioner Margaret Hamburg fought back, terming Zohydro “unique” and saying the drug’s benefits in treating chronic pain treat pain should outweigh fears of its potential for abuse.

The movement to ban Zohydro is a bipartisan effort – the Fed Up letter to Hamburg was signed by three Republican senators, Mitch McConnell (R-Kentucky), Lamar Alexander (R-Tennessee), and Tom Coburn (R-Oklahoma). McConnell is Senate Minority Leader and Alexander is a ranking member on the Health Committee.

A Senate overturn of an FDA approval for Zohydro would have a number of dramatic longterm consequences, including setting a precedent for this type of action. There would also be enormous consequences for Zogenix, Inc., the maker of Zohydro, which saw its stock drop in relation to the previous expert protest campaigns.

Zogenix’ tactics in winning approval for Zohydro have also come under fire.

A few weeks ago, according to blog TheHill, Manchin and Senator David Vitter (R-Louisiana) began looking into charges of undue influence by the pharmaceutical industry after complaints began surfacing that industry lobbyists contributed more than $10,000 to obtain meetings with the FDA to discuss Zohydro.

Just a week ago, Zogenix, Inc. announced that it would begin providing Zohydro to a limited number of pharmacies. Shares of Zogenix, Inc. (ZGNX) closed up 4.6 percent at $3.67.

Meanwhile, in a seemingly related development (possibly to head off a similar campaign) the makers of Oxycontin, Purdue Pharma, two days ago announced the company had developed a new more abuse-resistant formulation of the drug.

For more news about Zohydro and other health topics, follow me here on, on Twitter, @MelanieHaiken, and subscribe to my posts on Facebook.

Source: Forbes


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