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Lawmakers Seek To Lay Roadblock To Powerful Painkiller


From NPR News, this is ALL THINGS CONSIDERED. I'm Melissa Block.


And Robert Siegel. Zohydro is a powerful new painkiller. It hit the market this week and a big group of lawmakers and public health advocates want it back off pharmacy shelves. They're calling on the FDA to withdraw its approval and U.S. Senator Joe Manchin has introduced a bill to force the issue. Here's NPR's Laura Sullivan.

LAURA SULLIVAN, BYLINE: Zohydro is one of the most powerful prescription painkillers created. Swallowing just one capsule could kill a child. But what has critics most concerned is that unlike new formulations of Oxycontin and other painkillers, Zohydro is crushable. That means addicts can snort it, producing a euphoric high.

SENATOR JOE MANCHIN: To come out with something so much more powerful than what we've had on the market to date and the damage has already been done, makes no sense to me whatsoever.

SULLIVAN: Senator Joe Manchin is a Democrat from West Virginia which is battling what he calls an epidemic of prescription drug abuse. The state has the highest rate of drug overdose deaths in the country.

MANCHIN: We've got people crying out for help. We have people crying out every day.

SULLIVAN: If passed, Manchin's bill will force the FDA to remove its approval of Zohydro. The FDA's own advisory panel voted 11 to 2 not to approve the drug last fall. But top FDA officials overruled that decision, saying the drug was needed. Then emails became public that showed FDA officials participated in private meetings with pain drug companies that paid organizers thousands of dollars to attend. Zohydro's original manufacturer was among them.

FDA officials have said that the meetings benefitted patients as well, provided valuable research and did not provide any undue influence to drug companies. But Manchin says he has asked the FDA to provide details about those meetings for almost five months.

MANCHIN: I'm just trying to get answers. How in the world would something like this get approved? Show me that there's no connection whatsoever.

SULLIVAN: Almost a dozen other lawmakers on the Hill are also calling on the FDA to remove Zohydro's approval, so have attorneys general from 28 states as well as 42 public health organizations. FDA officials did not respond to questions about whether they would consider such a move.

In a statement, FDA commissioner Margaret Hamburg told NPR she was eager to work with Congress and to preserve patient's access to much needed pain medicine. This week, Purdue Pharma announced it was in the final stages of developing a drug almost identical to Zohydro except that its drug is tamper-resistant and can't be snorted. Laura Sullivan, NPR News, Washington. Transcript provided by NPR, Copyright NPR.

Laura Sullivan is an NPR News investigative correspondent whose work has cast a light on some of the country's most significant issues.
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