FDA Chief Wants to Test if Opioids Actually Work

FDA Commissioner Scott Gottlieb is making plans to compel pharmaceutical firms to test the safety and efficacy of prescription opioids, an area where research is surprisingly lacking.

"We are going to impose a mandate on existing products … to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction," Gottlieb told the Washington Post in a Tuesday interview.

The FDA will require the makers of brand-name pharmaceuticals to fund independent, randomized and controlled research of the effects of long-term opioid use for pain relief, Gottlieb said. Generic opioid makers would be required to adapt their behavior based on the result of said investigations.

Such studies were not previously something the FDA could compel pharmaceutical firms to undertake, Gottlieb told the Post. Previously, the regulatory agency only had the power to order post-market studies of safety, as opposed to efficacy. But, under the SUPPORT Act, passed last October, the FDA now has the ability to require studies of the effectiveness of on-the-market drugs.

The idea that the safety and effectiveness of opioid drugs still needs to be studied may surprise some. After all, humans have used opioids in their organic form for millennia, and their narcotic and analgesic effects have long been well-known.

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