The new Commissioner of the Food and Drug Administration (FDA), Scott Gottlieb, recently admitted to having committed certain mistakes when he was a part of the agency in the 2000s. While accepting that the government failed to regulate opioids more, he assured not to repeat the past mistakes.
Significantly, overdose deaths involving opioid pain relievers and heroin witnessed a whopping 200 percent increase since 2000, says the Centers for Disease Control and Prevention (CDC). According to a study published in the journal Drug and Alcohol Dependence (DAD), death rate related to pharmaceutical opioids witnessed a four-fold increase between 1999 and 2009. The increase in opioid-related complications can be attributed to improper regulation of prescription opioids by governments during late nineties and early 2000s, which Gottlieb agreed to.
“We didn’t get ahead of it. Nobody got ahead of it…The type of action we need to take to finally (address) this crisis is going to be far more dramatic than we would have had to do had we made certain decisions years ago,” he said while attending a National Academy of Medicine conference.
Gottlieb, who was sworn-in as the 23rd Commissioner of the FDA in May 2017, has been proactive in controlling opioid epidemic in the U.S. Here are some of the effective actions that are being taken by the FDA to control opioid abuse-related problems in the country.
Immediate-release (IR) opioids
These fast-acting painkillers constitute about 90 percent of opioid prescriptions. However, these opioids have higher addictive potential and a weaker oversight. Therefore, the FDA plans to regulate these drugs. This would make it mandatory for drugmakers to organize training programs for doctors on safe prescribing and non-opioid alternatives.
Setting prescription limits
Many states have passed laws limiting the first-time opioid prescriptions to seven days. Different pharmaceutical companies like CVS Health have supported the prescription limits, which Gottlieb referred to as “an inevitability.” CVS had recently announced to limit the amount and strength of opioid painkillers to help curb opioid abuse.
The FDA is set to issue guidelines to assist drugmakers who are seeking approval to develop generic version of abuse-deterrent formulations (ADFs) of opioids. Most of the currently approved ADFs are extended release/long-acting (ER/LA) formulations of opioids, which are known to have less abuse potential.
Dealing with opioid misuse
Easy access to opioids is one of the main factors behind opioid addiction, which can be fatal, if not treated at the right juncture. However, it is important to understand that addiction to any form of substance is manageable with timely treatment. Help people battling opioid addiction by encouraging them to seek professional help. One should not shy away from treatment for the fear of associated stigma. People misusing opioids can lead a sober life by getting treatment at a credible rehab center. If you have a loved one grappling with an addiction, seek immediate medical attention.
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