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Opioids

February 26, 2018 | Daily News

FDA's Office of Prescription Drug Promotion issued a warning to the maker of an abuse-deterrent opioid for allegedly understating the risks of the product, which included printing the limitations of abuse-deterrent technology below the benefits.

February 20, 2018 | Daily News

The Biotechnology Innovation Organization (BIO) in a newly released report found that development of and investment in novel pain medicines has been sorely lacking over the past decade, with only two novel chemical entities -- those with no prior approval history -- entering the market since 2007.

February 15, 2018 | Daily News

The future of a number of pain patient advocacy organizations and professional societies may be on shaky ground following the Tuesday (Feb. 13) release of a damning report that revealed 13 of these groups -- along with a non-patient-focused organization, the Washington Legal Foundation -- received nearly $9 million in funding over a five-year period from major opioid manufacturers.

February 15, 2018 | Daily News

The future of a number of pain patient advocacy organizations and professional societies may be on shaky ground following the Tuesday (Feb. 13) release of a damning report that revealed 13 of these groups -- along with a non-patient-focused organization, the Washington Legal Foundation -- received nearly $9 million in funding over a five-year period from major opioid manufacturers.

February 15, 2018 | Daily News

A number of pain management-focused patient advocacy groups and professional societies are on the defense after the release of a report showing that about 14 groups received nearly $9 million in funding from opioid manufacturers over a five-year period.

February 12, 2018 | Daily News

The Trump administration's newly released fiscal 2019 budget allocates $10 billion across HHS to address the opioid epidemic, $10 million of which would be dedicated to FDA investment in regulatory science and tools for stemming opioid abuse and misuse.

February 07, 2018 | Daily News

The draft budget deal announced by Senate leaders Wednesday (Feb. 7) includes a provision that would for the first time allow hospitals and doctors' offices to share Medicare claims data with standalone Part D prescription drug plans.

February 07, 2018 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) announced a budget deal with Senate Democrats on Wednesday (Feb. 7) that includes $6 billion to fight the opioid and mental health crises, and raises non-defense discretionary spending.

February 07, 2018 | Daily News

FDA is in talks with Congress -- and has had internal agency discussions -- to assess the agency’s authority to require all immediate-release (IR) formulations of opioids be packaged in three-, seven- or 14-day blister packs, FDA Commissioner Scott Gottlieb told stakeholders during a Tuesday (Feb. 6) event held by the Alliance for a Stronger FDA.

February 07, 2018 | Daily News

FDA Commissioner Scott Gottlieb touted the potential for FDA to use its Sentinel System to study the long-term effects and prescribing of opioids and how long-term use can lead to addiction.

February 07, 2018 | Daily News

A coalition of health care stakeholders representing distributors, caregivers, mental health advocates, pharmacists, patient education advocates and physician assistants have formed Allied Against Opioid Abuse (AAOA), a coalition aimed at educating health care providers, pharmacists and the public about responsible prescription opioid prescribing and use.

February 06, 2018 | Daily News

FDA officials met Tuesday (Feb. 6) with House Energy & Commerce Committee members, including Rep. David McKinley (R-WV), to discuss policies to strengthen FDA’s power to curb opioid abuse, including enshrining in law FDA’s ability to consider drug-abuse risk in product reviews.

February 01, 2018 | Daily News

Stakeholders are divided over whether there is a need for a national prescription drug monitoring program (PDMP), with some asserting the existing state systems simply need to be improved to enhance interoperability and data sharing and others calling for a national system that would provide real-time data and integrate into clinical workflows.

January 31, 2018 | Daily News

During his first State of the Union address on Tuesday (Jan. 30), President Donald Trump said his plans for immigration reform will help curb the opioid epidemic, but lawmakers and industry stakeholders said more needs to be done and some took issue with the Trump administration's continued lack of dedicated funding to help solve the crisis.

January 30, 2018 | Daily News

President Donald Trump in his first State of the Union Address trumpeted the repeal of Obamacare's individual mandate; repeated his vow to cut prescription drug prices; held up FDA's increased approval of new and generic drugs and medical devices; asked Congress to pass “Right to Try” legislation giving patients immediate access to experimental drugs; and pledged to fight the opioid epidemic.

January 30, 2018 | Daily News

FDA on Tuesday (Jan. 30) took what FDA Commissioner Scott Gottlieb painted as “unprecedented and novel action” by calling on marketers of drugs with a potential for abuse and misuse to voluntarily take steps to address public health issues, and specifically asked Imodium A-D makers to change their packaging.

January 30, 2018 | Daily News

The House Energy & Commerce Committee on Feb. 26 will hold its first hearing this year on ways to combat the opioid crisis, with a focus on new treatments and disposal options.

January 25, 2018 | Daily News

Medicaid providers and health plans need more guidance to clear up confusion surrounding federal privacy protections for medical records that contain information about substance abuse, members of the federal Medicaid advisory commission said Thursday (Jan. 25).

January 25, 2018 | Daily News

The Senate health committee on Thursday (Feb. 8) will hold its fourth hearing on the opioid crisis, focusing on the effects the crisis has on children and families and how states are taking action to ensure infants affected by drug abuse are taken care of.

January 25, 2018 | Daily News

A working group of prescribers, dispensers, manufacturers and professional societies is pushing a slate of reforms to help curb the opioid epidemic, which includes supporting funding to upgrade prescription drug monitoring program (PDMP) technology, expanding substance use disorder treatment options and ensuring patients' medical history is available in real-time so that providers and pharmacists have access to patient information.

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