Senate to Vote This Week on Opioid Bill With FDA Provisions
The Senate will vote later this week on a sweeping, bipartisan opioid bill that will seek to slow the opioid epidemic that killed more than 70,000 in 2017.Among the more than 70 proposals included in the bill are several related to the US Food and Drug Administration (FDA), the National Institutes of Health and other Department of Health and Human Services agencies.
“The House has already passed its version of the act, and there is a bipartisan urgency to work with our House colleagues to get the legislation to the President’s desk,” Sen. Lamar Alexander (R-TN) said in a statement.
On FDA’s end, the bill would require FDA to hold one or more public meetings on the challenges to developing non-addictive drugs to treat pain, “including how the risk of misuse and abuse may be incorporated into FDA’s assessments, novel clinical trial designs, and evidentiary standards related to opioid sparing.”
The bill would also require FDA to issue guidance on expedited pathways and how they apply to novel non-addictive pain or addiction treatments, pain endpoints and how product developers can design trials for non-addictive pain treatments, and opioid sparing that would “direct FDA to clarify requirements for opioid sparing data to be used in the label that a medicine is as effective at controlling pain and able to reduce, replace, or avoid the amount of opioids a patient needs to control pain.”
The agency also will be required to draft guidance on how it will consider the risks and benefits of drugs that have the potential to be misused or abused.
In addition to strengthening the relationship between FDA and Customs and Border Protection, the bill also clarifies FDA’s post-market authorities for drugs that may have reduced efficacy over time by “modifying the definition of an adverse drug experience to include such situations.”
The bill also would clarify FDA’s authority to require drugmakers to package certain opioids to allow for a specific treatment duration. The bill would also clarify FDA’s authorities to require manufacturers to give patients simple and safe options to dispose of unused opioids.