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April 26, 2018 | Daily News

The House Energy & Commerce health subcommittee on Wednesday (April 25) voted to send to the full committee more than 50 bills intended to help curb the opioid epidemic, as well legislation that would reauthorize FDA’s animal drug and animal generic drug user fees.

April 24, 2018 | Daily News

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.

April 23, 2018 | Daily News

FDA on Friday (April 20) published the first draft guidance -- of what the agency has promised will be two -- to help advance the development of medication-assisted treatment for opioid use disorder.

April 19, 2018 | Daily News

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.

April 19, 2018 | Daily News

The House Energy & Commerce health subcommittee will mark up a slate of opioid bills on April 25, the subcommittee announced Wednesday (April 18).

April 19, 2018 | Daily News

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.

April 17, 2018 | Daily News

On April 24, the Senate health committee will vote on bipartisan opioid and over-the-counter drug monograph reform legislation, but it will not mark up a cosmetic reform bill as previously promised by the committee chair, the committee announced Tuesday (April 17).

April 17, 2018 | Daily News

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.

April 17, 2018 | Daily News

Providers are proposing a Medicare alternative pay model aimed at treating opioid addicts that includes both a bonus-only option and an option the creates the prospect of bigger bonuses in return for accepting penalties for poor performance on spending measures for addiction-related services.

April 12, 2018 | Daily News

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.

April 12, 2018 | Daily News

Facebook Co-founder and CEO Mark Zuckerberg on Wednesday (April 11) promised that someone from Facebook will meet with FDA Commissioner Scott Gottlieb to address how the company can further address the issue of illicit opioid advertising on the social media site.

April 11, 2018 | Daily News

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.

April 10, 2018 | Daily News

FDA has created a new position in the agency's controlled substance office that will report directly to the drug center director and is expected to play a key role in devising the agency's policy response to the opioid crisis, Inside Health Policy has learned.

April 05, 2018 | Daily News

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.

April 04, 2018 | Daily News

The Senate health committee unveiled bipartisan draft opioid legislation on Wednesday (April 4) that would expand FDA’s authority to require manufacturers package certain drugs to allow for a set duration of treatment, such as in blister packs for three- or seven-day supplies, and provide patients with a simple and safe way to dispose of unused opioids.

April 04, 2018 | Daily News

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.

April 04, 2018 | Daily News

CMS will for the first time allow Medicare Part D plans to restrict beneficiaries who may be at risk of opioid abuse to a single prescriber or pharmacy under a detailed regulatory scheme that the agency issued Monday (April 2) as part of the 2019 final Part D rule, but some beneficiary advocates are concerned the rule could hurt dual eligibles' ability to switch plans.

April 04, 2018 | Daily News

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).

April 02, 2018 | Daily News

Medicare Advantage plan revenues next year will increase 3.4 percent, plus 3.1 percent in revenue from coding changes, thanks in large part to the Bipartisan Budget Act, CMS estimates.

March 29, 2018 | Daily News

The same day that the head of FDA attacked pharmacy benefit managers for high drug prices, HHS Secretary Alex Azar announced Thursday (March 29) that an executive of a big-three PBM will lead drug-price policy.