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FDA Pushes Development of Cheaper Generic Opiates

Possible Opioid Epidemic Solutions: FDA Pushes Development of Cheaper Generic Opiates

The current opioid epidemic that affects millions of people in America now claims as many as 91 lives a day on average, according to CDC reports. With a growing need for better solutions by the government to combat this wide-spread problem, the FDA pushes to try and make more alternative generic opiates available that are not as easily abused as the current medications that are commonly prescribed for chronic pain. The FDA not only wants more generic opioid alternatives to be available, but they want it to be cheap to easily compete with current brands.

Abuse-Deterrent Generic Opiates

Opioids are similar in effect to street drugs such as heroin. They also hold many of the risks of abuse that heroin does such as the highly addictive properties that can easily cause a person to abuse them.

In recent years, the development of generic opioids that had abuse-deterrent components was introduced as a way to lower the risk of abuse. The manufacturers of OxyContin changed their drug to make it turn into an unusable gel when dissolved that would otherwise be injected. Other generic opiates release naloxone – a drug used to counter the effects of opioid abuse – when they are crushed down to a powder.

According to a Tufts CSDD report, 96 percent of the opioid pain relievers prescribed in 2015 did not have any abuse-deterrent properties in them. FDA researchers suggest that this is mainly due to doctors and patients not being aware that there is a safer alternative to consider. While this may be one reason, another major factor is that the price of these alternatives is far higher than the commonly prescribed generic opioid medications.

The U.S. Department of Veteran Affairs said that if they had to switch to the current abuse-deterrent generic opioid medications that it would increase their annual spending on chronic pain relief medication from $100 million to $1 billion.

FDA Speeding up Abuse-Deterrent Opioid Alternatives

The goal that the FDA is trying to achieve is to lower the cost of generic opiates by helping to introduce more generic brands while at the same time making more abuse-deterrent opiates available for the people who need it.

The FDA is helping pharmaceutical companies navigate through the extensive regulatory process, ultimately leading to faster approval times of medication found to be appropriate. They are also making it clear what is considered to be abuse-deterrent, providing drug makers with the recommendations they need.

What Will the Potential Impact Be?

It is important to understand that this move by the FDA is just a small part of the solution. Even the abuse-deterrent versions of the drug can still be abused because the simplest way to use them – swallowing the pill – is still there. Furthermore, primary care physicians believe that these alternatives remove most or all of the risk of becoming addicted. This is not the case as the drugs are not abuse proof, they are just harder to abuse.

The biggest impact that the FDA’s faster approval process hopes to achieve is the reduction in cost. With the increase in competition, the prices should begin to fall to more affordable levels.

A side effect of the harder-to-abuse opioids may be that there will be an increase in heroin abuse and other illegal opioids that can be bought on the streets such as fentanyl. This is a situation that was seen in the OxyContin change that happened in 2010.

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Sources:

https://www.cdc.gov/drugoverdose/epidemic/index.html

https://www.healthline.com/health-news/generic-opioids-battle-opioid-epidemic#6