Over the past few weeks, FDA has been applauded by many for the efficiency and timeliness of 2012 drug approvals, along with several initiatives, such as the “Breakthrough Therapy” designation announcements with Vertex Pharmaceuticals. This progress in product approvals, overall Agency efficiency and the move to collaborate with industry to push science and much needed treatments forward is a welcome harbinger for 2013.
And, to kick-off 2013, FDA released its Draft Guidance for Industry – Abuse-Deterrent Opioids – Evaluation and Labeling, which represents one more proactive step in addressing the challenges of managing pain appropriately, while minimizing the risks of misuse and abuse in society.
Society’s Problem with Opioids
If you’ve watched television or picked up a newspaper in the past 10 years, you probably know about the social problems of addiction to opioid products such as oxycodone, along with associated societal issues such as crime and robbery. In the case that you’re not familiar with opioid abuse and misuse, check out The Partnership at Drugfree.org to see the challenges and what’s being done to curb the issue.
We see the problems on TV and movies, but many people see the evidence of opioid misuse and abuse among their friends and families. In its guidance, FDA has officially stated that “opioid abuse and misuse is a high public health priority,” and 2013 is the year the Agency will put parameters in place to create a clearer path for those pharma and biopharma companies developing solutions.
The Good News
- From an industry perspective, this guidance helps map out the path to conduct trials to glean the type of data that will demonstrate success in reducing abuse potential, and it outlines FDA’s commitment to “take a flexible and adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.”
- From a patient’s view, it’s acknowledgement that pain management is a critical health problem that people suffer from every day.
- For consumers, this guidance means there’s potential for less abuse of these products in our communities.
Overall, it’s a win-win-win for everyone involved. It’s refreshing to see FDA working alongside industry and patient advocacy to develop collaborative solutions for challenges, and in this case, a challenge that has deeply affected our society.
Since FDA has been so proactive – and it looks like 2013 will be no different – might the Agency next provide draft guidance for the pharmaceutical and biopharmaceutical industry about social media? Here’s to hoping.