State Attorneys General to FDA: What Were You Thinking When You Approved Powerful New Painkiller?

<a href="http://en.wikipedia.org/wiki/File:Ritalin-SR-20mg-1000x1000.jpg">Wikimedia</a>

Fight disinformation: Sign up for the free Mother Jones Daily newsletter and follow the news that matters.


Last month, Mother Jones reported that the Food and Drug Administration had approved a powerful new painkiller called Zohydro over the objections of its advisory board, which voted 11-2 against approving the drug. Now Attorneys General from 28 states (and the US territory of Guam) have asked the FDA to reconsider its approval of Zohydro. In a letter to the agency, the AGs raise many of the same concerns that the advisory panel did, noting that the drug lacks adequate safeguards to prevent it from being abused and could exacerbate America’s epidemic of painkiller deaths. Here’s an excerpt from the AGs letter, which was dated December 10:

State Attorneys General do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed. This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors over-prescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives.

Zohydro, which is made by a company called Zogenix, is five to ten times stronger than Vicodin, making it very similar in potency to OxyContin, a widely abused prescription drug that has contributed to the tens of thousands of painkiller-related deaths in the United States. OxyContin, however, now includes a gel that prevents the drug from being crushed and snorted. Zohydro was approved without that measure. Zogenix has entered into a $750,000 agreement with a Montreal-based company, Altus Formulation Inc, to help make the drug abuse-deterrent, but it’s unclear whether the formula will be ready by the time Zohydro hits the market in a few months.

The Attorneys General don’t think that’s sufficient. “We hope that the FDA either reconsiders its approval of Zohydro ER, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies to impose restrictions on how Zohydro ER can be marketed and prescribed,” they wrote in their letter.

AN IMPORTANT UPDATE

We’re falling behind our online fundraising goals and we can’t sustain coming up short on donations month after month. Perhaps you’ve heard? It is impossibly hard in the news business right now, with layoffs intensifying and fancy new startups and funding going kaput.

The crisis facing journalism and democracy isn’t going away anytime soon. And neither is Mother Jones, our readers, or our unique way of doing in-depth reporting that exists to bring about change.

Which is exactly why, despite the challenges we face, we just took a big gulp and joined forces with the Center for Investigative Reporting, a team of ace journalists who create the amazing podcast and public radio show Reveal.

If you can part with even just a few bucks, please help us pick up the pace of donations. We simply can’t afford to keep falling behind on our fundraising targets month after month.

Editor-in-Chief Clara Jeffery said it well to our team recently, and that team 100 percent includes readers like you who make it all possible: “This is a year to prove that we can pull off this merger, grow our audiences and impact, attract more funding and keep growing. More broadly, it’s a year when the very future of both journalism and democracy is on the line. We have to go for every important story, every reader/listener/viewer, and leave it all on the field. I’m very proud of all the hard work that’s gotten us to this moment, and confident that we can meet it.”

Let’s do this. If you can right now, please support Mother Jones and investigative journalism with an urgently needed donation today.

payment methods

AN IMPORTANT UPDATE

We’re falling behind our online fundraising goals and we can’t sustain coming up short on donations month after month. Perhaps you’ve heard? It is impossibly hard in the news business right now, with layoffs intensifying and fancy new startups and funding going kaput.

The crisis facing journalism and democracy isn’t going away anytime soon. And neither is Mother Jones, our readers, or our unique way of doing in-depth reporting that exists to bring about change.

Which is exactly why, despite the challenges we face, we just took a big gulp and joined forces with the Center for Investigative Reporting, a team of ace journalists who create the amazing podcast and public radio show Reveal.

If you can part with even just a few bucks, please help us pick up the pace of donations. We simply can’t afford to keep falling behind on our fundraising targets month after month.

Editor-in-Chief Clara Jeffery said it well to our team recently, and that team 100 percent includes readers like you who make it all possible: “This is a year to prove that we can pull off this merger, grow our audiences and impact, attract more funding and keep growing. More broadly, it’s a year when the very future of both journalism and democracy is on the line. We have to go for every important story, every reader/listener/viewer, and leave it all on the field. I’m very proud of all the hard work that’s gotten us to this moment, and confident that we can meet it.”

Let’s do this. If you can right now, please support Mother Jones and investigative journalism with an urgently needed donation today.

payment methods

We Recommend

Latest

Sign up for our free newsletter

Subscribe to the Mother Jones Daily to have our top stories delivered directly to your inbox.

Get our award-winning magazine

Save big on a full year of investigations, ideas, and insights.

Subscribe

Support our journalism

Help Mother Jones' reporters dig deep with a tax-deductible donation.

Donate