Zohydro ER Approval Still Under Debate in Congress

Posted September 29, 2014 at 3:37pm

The powerful painkiller Zohydro ER has been a lightning rod in the prescription drug abuse debate. Amid a backdrop of steadily increasing opioid abuse rates, the Food and Drug Administration cleared Zohydro for the market last fall, against its advisory board’s recommendation. The drug is the first of its kind.

Health officials maintain the pain reliever — which is an extended-release drug that purely contains hydrocodone — is instrumental in treating patients with chronic pain because the pill lacks acetaminophen, which can cause liver damage. But critics of the drug argue that the same component makes it more powerful and thus more appealing for people to abuse it.

Zohydro’s approval created a political firestorm on Capitol Hill and among states. Rep. Stephen F. Lynch, D-Mass., and Sen. Joe Manchin III, D-W.Va., introduced legislation (HR 4241, S 2134) in March that would withdraw the FDA’s approval of the drug, while several states have either banned the drug or limited its prescription.

The fury has not subsided. This month, anti-addiction groups wrote a letter to the Department of Health and Human Services, calling for FDA Commissioner Margaret Hamburg to resign over Zohydro’s approval. “Dr. Hamburg’s support for using opioids to treat chronic non-cancer pain is squarely at odds with efforts by the CDC to discourage this widespread practice,” the letter said.

Hamburg has routinely defended the drug during Congressional hearings.

“We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche,” Hamburg said during a Senate Health, Education, Labor and Pensions Committee hearing.

The FDA said it remains committed to both providing appropriate options for pain management and reducing opioid abuse, emphasizing that actions to advance one do not have to impede the other.