FDA Pushes for the Development of Abuse-Deterrent Generic Opioids

Generic opioids are cheaper than brand name versions, but they’re not available in abuse-deterrent formulations – yet. The FDA hopes to change that.

The opioid crisis is in full swing, with opioid overdoses claiming 91 lives every day in the U.S. In November, 2017, the FDA issued a set of guidelines for drug companies to encourage the development of generic opioids with abuse-deterrent formulations in hopes of stemming the opioid crisis. But are generic opiates the answer? Opinions vary.

Abuse-Deterrent Formulations: The Most Expensive Opioids on the Market

The FDA has, to date, approved nearly a dozen prescription opioid painkillers with abuse-deterrent formulations, or ADFs. ADFs are designed to make these medications more difficult to abuse or less rewarding when they’re abused.

Opioid medications are often abused by crushing the tablets into a power that’s injected or snorted, thereby administering the full dose all at once. But drug companies use ADFs to discourage this type of abuse in a number of ways, including:

  • Creating tablets that can’t be crushed.
  • Adding naloxone, an opioid antagonist, to block the euphoric effects of the medication when it’s crushed.
  • Creating tablets that turn into a gel when they’re dissolved.
  • Adding “prodrugs” that prevent the activation of the drug until it’s dissolved in the stomach.

All of the abuse-deterrent formulations on the market today are branded and very expensive, which means they’re incredibly lucrative for drug manufacturers. And in fact, drug companies are engaging in heavy lobbying to make sure more people have access to these pricy meds. The New England Journal of Medicine reports that pharmaceutical companies out-spent the gun lobby between 2006 and 2015 to influence opioid policies at the state and federal levels and promote widespread use of abuse-deterrent formulations. One of many goals of the lobby is to ensure that all states require insurance companies to cover the cost of these ultra-expensive formulations.

However, many experts worry that the impact of these and other pro-ADF laws on insurers and the healthcare system as a whole would be financially unsustainable. For example, one study found that if the U.S. Department of Veterans Affairs alone switched to ADFs only, its current yearly opioid spending of $100 million would increase to around $1 billion.

Enter the FDA’s Guidelines for Abuse-Deterrent Generic Opioids

A recent study by the Tufts Center for the Study of Drug Development found that just four percent of all opioid medications prescribed in 2015 were ADFs. The FDA hopes to change that in the coming years by speeding up the development of generic opioids with ADFs to increase access to these medications.

To do this, the FDA plans to assist drug manufacturers to quickly navigate the regulatory process for generic opioid medications. Additionally, the newly issued guidelines include recommendations for studies that could be done to ensure the generic opiates with ADFs meet the same abuse-deterrent standards as brand-name ADFs.

The Limitations of Abuse-Deterrent Opioid Formulations

Not everyone is riding the ADF bandwagon, however. While proponents of ADFs argue that standard formulations enable tampering and abuse, detractors cite a number of studies showing that ADFs do little overall to stem the tide of opioid abuse.

For one thing, ADFs don’t prevent individuals from abusing these medications by simply swallowing larger doses of pills, which is the most common method of abuse. Furthermore, ADFs are only abuse-deterrent, not abuse-proof. A proliferation of videos on YouTube walk viewers through the process of getting around the abuse-deterrent features. Additionally, research shows that the majority of people who become discouraged by abuse-deterrent formulations simply switch to heroin. This would be unlikely to change in light of a proliferation of generic opioid medications with ADF.

Instead of focusing on developing generic opioids with ADF, the New England Journal of Medicine encourages policymakers and researchers to carefully examine all of the evidence regarding the risks and benefits of using opioids to treat pain–particularly new research showing that long-term opioid therapy is largely ineffective and that prolonged use is associated with serious health problems. Instead of focusing on developing new ADFs, according to the journal, researchers should invest in the development of alternative medications and other treatments for chronic pain.



If you or a loved one needs help with abuse and/or treatment, please call the WhiteSands Treatment at (877) 855-3470. Our addiction specialists can assess your recovery needs and help you get the addiction treatment that provides the best chance for your long-term recovery.

About the Author

is a proud alumni member of WhiteSands Treatment. After living a life of chaos, destruction and constant let downs, Mark was able to make a complete turnaround that sparked a new way of life. He is serious about his recovery along with helping others. At WhiteSands Treatment, we offer support to you in your homes or when you are out living in your daily lives.