Opioids

The Senate health committee voted unanimously on Tuesday (April 24) in favor of a package of opioid legislation, which includes 40 bills from 38 senators.

The newly appointed top HHS official on opioid policy faced tough questions Thursday (April 19) from Democrats on the Senate Finance Committee about whether he would take aggressive action against opioid manufacturers and distributors, and the committee’s ranking Democrat, Sen. Ron Wyden (OR), said the committee should summon the executives of those companies to testify about their role in the opioid crisis.

Sen. Bernie Sanders (I-VT) on Tuesday (April 17) introduced a bill that would impose billions of dollars of civil penalties on drug manufacturers caught falsely promoting opioids as not addictive and on distributors supplying unreasonable amounts of opioids to communities, as well as potential jail time for individual employees that run afoul of the rules.

House Appropriations agriculture subcommittee chair Robert Aderholt (R-AL) called FDA's request for a 13 percent increase in funding over fiscal 2018 levels “the largest and boldest funding request in recent memory and maybe ever” and signaled it might have to be cut back, but Democrats argued the budget lacks enough funding for food safety and opioids.

After a two-day hearing on the role of Medicare and Medicaid in fighting the opioid crisis, House Energy & Commerce health subcommittee Chair Michael Burgess (R-TX) said Thursday (April 12) that he is still deciding whether to combine numerous opioid-related bills into a single legislative package or try to move the bills through committee individually.

Senate health committee Chair Lamar Alexander (R-TN) said he will work with Sen. Bill Cassidy (R-LA) to include in the committee's opioid-response bill a provision clarifying when it is okay for hospitals to notify a patient's family and health care provider of the patient's non-fatal overdose.

United States Surgeon General Jerome Adams on Thursday (April 5) issued an advisory encouraging expanded use of the overdose-reversing drug naloxone -- a move promptly backed by FDA Commissioner Scott Gottlieb, who is pressing drug makers to seek approval of over-the-counter versions of the product.

FDA Commissioner Scott Gottlieb calls on social media companies and internet service providers (ISPs) to help “crack down” on illegal opioid distribution via the internet, saying the agency wants to collaborate with these firms on responsible approaches to eliminate illegal opioid distribution.

FDA hopes to spend $10 million in fiscal 2019 to advance its efforts to help stem opioid misuse and abuse by, among other things, accelerating development of generic abuse-deterrent formulations of opioids (ADFs), the agency states in a budget justification document unveiled Monday (April 2).