- - Monday, March 21, 2016

ANALYSIS/OPINION:

Prescription drug abuse has reached epidemic proportions in communities across our country. Approximately 15 million adolescents and adults abused prescription drugs in the past year. Abuse is the leading cause of accidental death in the country, with 44 Americans dying each day from overdosing on prescription painkillers.

No state is immune. In my own state of Utah, abuse has gone up by nearly 400 percent in recent years, with 24 people dying each month because of prescription drug overdoses. Utah now ranks fourth among states for drug poisoning deaths, and deaths have outpaced fatalities from other factors, such as motor vehicle crashes.

While prescription painkillers can be an important component of a patient’s recovery process, these medications are being misused far too often by people who should not have access to them in the first place.

As Utah’s attorney general, I am on the front line of the battle against drug abuse. I have seen just how deadly prescription drugs can be when not used properly. In Utah and all across the country, abuse takes the lives of children, parents, friends and coworkers. Drug addiction and diversion fuel crime in cities and towns, and abuse drives up our country’s health care costs by billions of dollars each year.

I am committed to safeguarding Utah’s communities and protecting the well-being of our citizens. This is why addressing the drug abuse epidemic is such an important priority for me. And this is why I am asking Washington to help in the fight.

This past week, the Centers for Disease Control and Prevention released new guidelines for doctors who prescribe opioid pain medicine to their patients. The guidelines call for giving preference to over-the-counter painkillers, prescribing lower doses of opioid pain medicine when these medications are needed, and ensuring patients know the risks of using prescription painkillers. These protocols will be an important tool in helping to stem abuse, but the guidelines do not address the prescription opioids that will remain available for those patients who truly need them.

Two years ago, attorneys general from 42 states and territories joined together in calling on federal regulators to mandate that any prescription opioid coming to market be formulated in a way that makes it harder for individuals to abuse the medication. When manufactured with abuse-deterrent technology, pain pills are much harder to crush, inject, or inhale. Alongside other measures, such as prescription-drug monitoring programs like Utah’s Controlled Substance Database, abuse-deterrent technologies have been shown to help bring down rates of abuse.

I commend the Food and Drug Administration (FDA) for their announcement last month that they will be reassessing the approach to opioid medications and conducting a policy review to develop frameworks for making the use of prescription narcotics safer. As part of this, the FDA stated that it would encourage the development of painkillers with abuse-deterrent formulations. These are strong initial steps to curbing prescription drug abuse, but three specific commitments are still needed.

First, the FDA should commit to following recommendations made by its advisory committees. In making its policy review announcement, the FDA stated that it would convene an advisory committee before approving any new drug application for a painkiller that is not formulated using these technologies. This is a welcome policy to which the FDA should strictly adhere.

In 2013, the FDA approved the painkiller Zohydro, even though the agency’s own advisory committee voted overwhelmingly against approval because the drug lacked abuse-deterrent technology. Following the decision, attorneys general from 28 states called on the FDA to reconsider its decision.

Second, while encouraging the development of abuse-deterrent formulations on the pharmaceutical end is critical, we also need to give doctors the information they need to make smart and safe prescription decisions. It is critical that physicians be able to determine easily which painkillers contain abuse-deterrent formulations and which do not. For this reason, the FDA should mandate new labeling requirements that clearly differentiate whether opioids are formulated with abuse-deterrent technology or not.

Third, the eventual expansion of abuse-deterrent opioids into the generic market will likely help make these safer formulations more widespread. In their recent announcement, the FDA committed to finalizing the draft guidance for development of generic abuse-deterrent opioids. It is important that the generic guidance be implemented in a way that maintains the abuse-deterrent integrity of the reference product. Additionally, the FDA should strive to adhere to their commitment to release this guidance as soon as possible.

Prescription drug abuse is not an issue that is limited to one city, one state or one region of our country. It is an issue that does not discriminate. Because of this, we must all work together toward its elimination. By making strong commitments when it comes to battling abuse, the FDA can be a powerful leader in the fight.

Sean D. Reyes is the attorney general of Utah.

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