Independent panel advise FDA to apply different framework to opioid painkillers
Over a year ago, the Obama administration asked the National Academies of Sciences, Engineering, and Medicine to advise them on how best to tackle the prescription opioid abuse problem facing North America.
The panel returned to the agency with several actions to improve the crisis, the most dramatic of which would be, if implemented, the requirement of real-world data to determine whether to approve opioid medications and whether to keep them on the market.
The aim of the proposal, on more complete data collection, being to provide an adequate understanding of whether a painkilling drug could potentially be abused, and the likelihood of this happening. It also suggested for the FDA to analyse how drugs may be exploited by criminal elements and on demand for heroin.
The FDA has recently taken action based on evidence in the public sphere. It could be pointed out that this is exactly what happened with FDA’s recent call for Endo Pharmacetuicals’ Opana ER to be pulled from the market, although it could be countered that this came long after approval.
Beyond this, the report recommended many smaller measures the panel believes could allow opioid painkillers to remain on the market without the disastrous consequences that have mounted in the past decade. It recommended that long-term use of opioids to manage chronic pain should be avoided, due to the dangers of addiction and increased likelihood of overdose.
In recommendations wider than the FDA’s remit, it recommended that better access to treatment for opioid addiction should be made available and programs where individuals could return unused opioids to pharmacy at any time.
Commissioner of the FDA, Scott Gottlieb, released a statement on the report, part of which read: “Reducing the scope of the epidemic of opioid addiction is my highest immediate priority as Commissioner, and since joining the FDA two months ago, I’ve been working with my colleagues to capitalize on the good work that has already been done and expand those efforts in novel directions. I’ve asked my FDA colleagues to take a fresh look at some key features of the agency’s regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce overall exposure to these drugs. As we continue these efforts, I was encouraged to see that many of NASEM’s recommendations for the FDA are in areas where we’ve already made new commitments.”
Later in Gottlieb’s statement, he stressed that a coordinated effort is needed to tackle the issue. Indicated in the above statement, it seems that the FDA feels it is doing what it can and it needs further support from other areas.
It seems that this message is beginning to take hold as Federal Reserve Chair Janet Yellen recently addressed the issues opioid abuse cause to the labour force. The same day that Federal law enforcement agencies also announced that it had arrested 120 individuals across the country over fraudulently enrolling patients in premium insurance plans to generate profit for themselves.
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