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Abuse-deterrent opioids cross an ethical line

By in Press Enterprise on November 24, 2017

By Jeffrey A. Singer

The Commissioner of the Food and Drug Administration, addressing agency staff in May 2017, called the problem of opioid abuse “unquestionably, our greatest immediate challenge.” At the time, the Centers for Disease Control and Prevention had reported 33,000 opioid overdose deaths in 2015, the majority from heroin and fentanyl. Sadly, next month the CDC is expected to report much worse mortality numbers for 2016.

Among the steps the FDA is taking to combat this trend is its policy of encouraging drug makers to develop abuse-deterrent formulations of prescription opioids. The idea is to make it more difficult for opioid abusers to engage in nonmedical use of prescription opioids. In September the FDA announced it will soon issue an updated guidance document to assist manufacturers in developing an expanded spectrum of ADFs including generic versions.

Yet evidence shows that ADFs inflict harm — unintentional and intentional — on nonmedical drug users. By promoting them, the government might be crossing an ethical line, and it wouldn’t be the first time the government has done so when addressing substance use and abuse.

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