FDA: Combating opioid abuse

Today, more Americans tragically die from drug overdoses than from any other form of death by injury. A staggering 40% of those deaths involve prescription opioids. Identifying solutions to prevent prescription opioid abuse while ensuring that patients with debilitating pain have access to effective treatment is a top priority for FDA.

As a public health agency, FDA reviews drugs using a scientific approach within our legal framework and not only considers those who abuse opioids, but also those who use them responsibly.

While we appreciate the concern surrounding our recent approval of Zohydro, it should be recognized that Zohydro is a time-released analgesic that, without the added risk of acetaminophen, fills a need for pain patients who respond best to hydrocodone.

Zohydro is a very small fraction of the opioid marketplace. Singling out any individual opioid diverts the nation's focus from interventions that can make a real difference.

The problem of opioid overdose is largely driven by inappropriate prescribing, use and diversion of these drugs. FDA is part of a broader administrationwide strategy to combat opioid abuse.

In 2012, FDA required manufacturers of extended-release opioids to develop programs to educate prescribers about the drugs' potential risks. We also made changes to strengthen warnings on the labels of extended-release opioids and required manufacturers to conduct additional use studies.

To reduce the abuse of products such as Vicodin, the Drug Enforcement Administration followed FDA's recommendation to restrict prescriptions of hydrocodone combination products.

We continue to encourage the development of both non-opioid pain medications and technologies that will make opioids less susceptible to abuse. FDA is also supporting the development of better treatments for addiction.

Opioid abuse in this country can only be brought under control by concerted effort from many: prescribers, pharmacists, scientists, public health officials, law enforcement, patients and their families. FDA will continue to do its part to overcome this public health crisis.

Dr. Margaret A. Hamburg is commissioner for the Food and Drug Administration.