The U.S. FDA issued new guidelines on generic opioid painkillers, but will it have an effect on the nation's growing addiction crisis?
Opioid addiction is one of the biggest public health crises facing the United States, and policymakers have had a rough time taking steps to address it. According to a report from Modern Medicine Network, however, the U.S. Food and Drug Administration is taking steps to influence policy decisions surrounding the effective yet dangerous opioid class of painkillers and medications.
The FDA recently issued draft guidance to help pharmaceutical companies develop generic versions of opioid medications with built-in abuse-deterrent formulations, of ADFs. ADFs make it harder for users to abuse opioid medications, and currently brand name drugs are required to include these formulations in their products. There is no such rule for generic opioids, however.
According to FDA Commissioner Robert Califf, “For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care. We recognize that abuse-deterrent technology is still evolving, and is only one piece
of a much broader strategy to combat the problem of opioid abuse.”
Examples of abuse-deterrent technology would include making it more difficult and less rewarding to crush a tablet to be snorted up the nose or dissolved in water to be injected directly into the bloodstream. The FDA acknowledges that such technologies don’t make it impossible to abuse opioid painkillers, but they can make the difference between someone simply swallowing a pill and opting for amore dangerous delivery method.
One of the biggest issues surrounding opioid abuse in the U.S. is the likelihood that a person struggling with addiction would begin using heroin, a much cheaper and much more dangerous opioid drug. Heroin use rates are on the rise again in the U.S., and many researchers believe that it’s due to the widespread availability of opioid prescription painkillers. As people become addicted, the habit becomes too expensive to support, leading many to make the switch to the cheaper alternative.
It remains unclear as to whether the new guidelines will have a measureable effect on opioid addiction in the U.S., but there should be policies in place to regulate this class of medications with a huge potential for abuse.
A press release from the FDA describing the details of the recently proposed guidelines can be found here.