U.S. Senators Todd Young (R-Ind.) and Joe Donnelly (D-Ind.) Tuesday announced that they have introduced two new bipartisan bills to help combat the opioid crisis in Indiana. The Advancing Innovation in Alternative Pain and Addiction Therapies Act and the Providing Clarity in the Development of Pain Treatments Act both aim to help bring non-opioid or non-addictive pain medications and treatments to patients more quickly.
“As the opioid epidemic continues to devastate families in Indiana and across the nation, we must accelerate the development of non-addictive pain medications and treatment,” said Senator Young. “In the year 2016, there were at least 785 drug overdose deaths involving opioids in Indiana. That’s 785 people who didn’t come home to their families. These two bipartisan bills will help us take a step forward in combating this crisis and saving lives.”
“As the opioid crisis continues to wreak havoc on families and communities in Indiana and across the country, it’s clear there’s a need for new, alternative treatments for those battling chronic or acute pain,” said Senator Donnelly. “I was proud to introduce these bipartisan bills that would require the FDA to offer guidance clarifying how it will assess new treatments that reduce the need for opioids, and safely speed up the approval process to bring non-opioid and non-addictive pain and substance use disorder treatments to market — which would encourage the development of these alternative painkillers.”
In 2012, the Advancing Breakthrough Therapies for Patients Act created a safe pathway for the US Food and Drug Administration (FDA) to expedite approval for treatments that show dramatic responses in early development. Similarly, the Accelerated Approval Program allows earlier approval of drugs that treat serious medical conditions and fulfill an unmet need. While these approvals are regularly granted, there is currently a lack of clarity surrounding the approval process for alternatives to opioids and treatments for addiction. The Advancing Innovation in Alternative Pain and Addiction Therapies Act introduced today clarifies this process to bring novel, non-addictive drugs and treatments to market more quickly.
The Providing Clarity in the Development of Pain Treatments Act also provides much-needed clarification through FDA guidance regarding opioid sparing and the circumstances related to the benefits and risks of pharmaceuticals.
Currently, FDA guidance essentially requires a medical product manufacturer to conduct a 12-week randomized, controlled trial to make the claim that their medical product is effective at controlling pain while reducing, replacing, or eliminating the use of opioids, also called “opioid sparing.” However, concerns have been raised regarding the ethical implications of having a study which gives opioids to patients for that period of time. This legislation instead requires FDA to address appropriate methods for data collection on opioid-sparing and inclusion of such data in product labeling for new treatments.
This legislation also requires FDA to issue clear guidance on how the agency will consider the entire benefit-risk profile of a given drug, including the benefits to newer and safer alternatives to conventional opioids and the risks of drugs that have the potential to be misused or abused. By taking both the benefits and the risks of drugs into account, FDA can better protect public health while promoting innovation.
