Pharmaceutical

FDA acted too slow on curbing opioid epidemic, FDA chief says

pills opioid 375x121 FDA acted too slow on curbing opioid epidemic, FDA chief saysToo many prescriptions are being written in the U.S. for opioids, and the duration of those drugs are often longer than needed. It’s time the Food and Drug Administration (FDA) stopped dragging its feet and develops guidelines for prescribing these highly addictive opioids, FDA Commissioner Scott Gottlieb said in a speech to the National Academies of Sciences, Engineering, and Medicine this week.

“For too long, it’s been too easy for doctors to prescribe lots of pills,” he said. “We want to make the easy and sensible decision, the one to dispense just a day or two of medicine, where that makes sense for the medical condition or procedure,” he said.

The country’s opioid epidemic that fuels the misuse and abuse of prescription pain relievers, illegal heroin, and synthetic opioids like fentanyl, kills more than 115 people in the U.S. every day, according to the National Institute on Drug Abuse. Not only does the opioid crisis take lives, it also places an economic burden on communities. The Centers for Disease Control and Prevention (CDC) estimates that prescription opioid misuse in the U.S. costs $78.5 billion a year in health care, lost productivity, addiction treatment, and criminal justice involvement.

Gottlieb admitted that the FDA is, in part, to blame. “We were too slow to change labeling on certain drugs to discourage chronic prescribing in situations where it is inappropriate,” he said. “We were too slow to recommend changing the scheduling of hydorocodone to restrict its access when there were signs of mounting abuse. And we were too slow to advance efforts to make proper physician education more routine.”

As a result, the FDA plans to develop evidence-based guidelines for safe prescribing of opioids in hopes that the new guidelines will be incorporated into the language on the safety labels of these drugs. The agency will also seek to better understand the relationship between total daily dose and the risk of addiction with these powerful painkillers.

For example, Gottlieb said, “We know from the medical literature that high school students exposed medically (to opioids) are more likely to use opioids in young adulthood in a non-medical setting.”

Sources:
Law360
National Institute on Drug Abuse