FDA's approval of Zohydro ER hydrocodone bitartrate from Zogenix Inc. has reignited debates about the best ways to balance the needs of pain patients and concerns about opioid drug addiction, abuse and overdoses. Calls from powerful politicians to reverse FDA's decision to approve Zohydro have also revived concerns about the politicization of drug oversight.

The voices of pain patients have been drowned out by Zohydro's critics, in part because critics of FDA's approval have made extraordinary claims about the drug's potency and abuse potential.

The agency approved Zohydro in October 2013 to manage chronic pain severe enough to require a continuous, around-the-clock opioid analgesic when alternatives are inadequate. The product is an oral, non-abuse deterrent extended-release formulation of hydrocodone (see BioCentury, Oct. 28, 2013).

Sen. Chuck Schumer (D-N.Y.) has been leading the charge against FDA's decision. In a March 3 press release, Schumer said: "It is baffling that at the same time policy makers and law enforcement officials are waging a war on the growing prescription drug crisis, we are essentially rolling out the welcome mat to a new, more powerful, and easily abused super-drug."

Efforts by Massachusetts Gov. Deval Patrick to ban Zohydro sales in his state were rebuffed last week by a U.S. District Court judge who ruled that states cannot overrule an FDA approval.

The judge also concluded that allowing Zohydro to be sold in Massachusetts is in the public interest. While a ban would prevent abuse, it would also prevent pain patients from "receiving the relief Zohydro ER offers," according to the ruling.

Nevertheless, Schumer and other Obama administration allies, along with prominent Republicans including Rep. Hal Rogers (R-Ky.), who is chairman of the House Appropriations Committee, are continuing to press for legislation to force the withdrawal of Zohydro. They have also asked departing HHS Secretary Kathleen Sebelius to overrule FDA's approval.

Many of the claims about Zohydro are incorrect, and efforts to trump FDA's approval threaten the integrity of science-based regulation, FDA Commissioner Margaret Hamburg said in an interview with BioCentury This Week television. Edited excerpts follow. The full interview is available at www.BioCenturytv.com.

BioCentury This Week: An advisory committee voted 11-2 to recommend against approving Zohydro. Governors, senators, even the attorney general have weighed in, questioning the decision. Why did FDA approve the drug?

Margaret Hamburg: I certainly understand the broader concerns that are motivating some of this in terms of the terrible public health burden of opiate addiction, abuse, misuse and overdose. But there is a need for adequate pain treatment of patients. And Zohydro, in fact, does represent an important pain medicine for people that respond better to hydrocodone - or if you need to rotate pain medicines because of chronic use - who don't want to be exposed to acetaminophen, which is a leading cause of liver toxicity, often even fatal liver toxicity.

And all of the other hydrocodone products currently in the marketplace are combined with acetaminophen.

BCTV: The governor of Massachusetts and several members of Congress have said Zohydro is superpotent and more addictive than other opioids.

MH: One of the common misperceptions is that this is the most potent opiate out there. And that simply isn't true. The second is that the other opiates out there have abuse deterrent formulations. And we wish that that were so. But in fact, almost without exception, the abuse deterrent claims of some of the products really don't hold water when tested.

And the one abuse deterrent formulation that has met the FDA criteria for labeling as abuse deterrent actually only provides deterrence against immediate injection or nasal intake - snorting. But it does not prevent oral abuse. And the majority of opiate overdose and abuse is through the oral route, not injection.

BCTV: Is there any deterrent now or even conceivable that's going to prevent somebody who's determined to abuse an opioid from doing that?

MH: Certainly not in terms of the formulation of the drug. There is nothing that can, at the present time, deter a determined abuser.

BCTV: Massachusetts and Vermont have tried to ban Zohydro. Other states are talking about it. What are the consequences of having states take that unprecedented action of overruling FDA approval?

MH: I do think that it's quite troubling. And I understand the motivation behind some of these actions in terms of the pressing need to reduce the burden of opiate addiction and preventable disease and death. But I think people should step back and really think very carefully about what it means for states or the Congress to start dictating what drugs should be approved and which ones should be withdrawn from the marketplace.

You can easily look at scenarios that are increasingly worrisome where, because of ideological beliefs or dislike for certain patient categories or other criteria, drugs that could make a difference in people's lives get banned.

BCTV: Some members of Congress have written to the HHS secretary and asked her to overrule FDA's decision. What happens if we have a political system where political appointees can overrule FDA on decisions that members of Congress don't like?

MH: I think it's very worrisome. FDA has a very carefully defined legal regulatory framework for our decision making. Most importantly, we are driven by the science, and there is a set of scientific database standards for product review and approval. When individuals who have very different backgrounds and are in the political environment, not the scientific environment, start making the decisions for the public, you can end up in some very worrisome places.

The broadcast of BioCentury This Week in Washington, D.C., is made possible by sponsors that share BioCentury's interest in providing a forum for public discussion of critical issues in healthcare. BioCentury This Week's Sponsors include Biogen Idec Inc., BIO and Johnson & Johnson.


U.S. Food and Drug Administration (FDA), Silver Spring, Md.

Zogenix Inc. (NASDAQ:ZGNX), San Diego, Calif.