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Opioids

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.

January 24, 2018 | Daily News

Doctors, insurers, and state officials are calling on Congress to loosen privacy protections for medical records so that providers can more easily find out if their patients have a history of substance abuse, but some privacy advocates are concerned the proposed legislation might go too far.

January 23, 2018 | Daily News

Congress should pass a health care package by Feb. 8 that funds so-called extenders and addresses other issues that were left out of the temporary spending bill that reopened the government, Senate Minority Leader Chuck Schumer (D-NY) told colleagues Tuesday (Jan. 23).

January 11, 2018 | Daily News

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).

January 11, 2018 | Daily News

During the Senate health committee's Tuesday (Jan. 9) hearing on the opioid crisis, author and journalist Sam Quinones cautioned Congress against “acting too quickly” and looking for short-term solutions to the opioid crisis.

December 27, 2017 | Daily News

One lawmaker is upset FDA has yet to provide him details on how the agency will address use of unapproved non-opioid products and off-label uses of non-opioid products for acute and chronic pain treatment.

December 01, 2017 | Daily News

FDA on Thursday (Nov. 30) approved the first once-monthly buprenorphine injection -- a drug-device combination product -- to be used to treat moderate-to-severe opioid use disorder (OUD).

November 29, 2017 | Daily News

HHS Secretary-nominee Alex Azar declined to commit to pushing Congress to appropriate at least $45 billion to fight the opioid epidemic during a Senate health committee hearing Wednesday (Nov. 29) on his nomination.

November 29, 2017 | Daily News

The Cato Institute is urging the government to stop promotion of abuse-deterrent formulations (ADFs) of opioids, saying they do more harm than good and promoting their use is unethical.

November 22, 2017 | Daily News

The head of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the CEO of a major opioid manufacturer are on the defensive over a New York Times editorial lambasting the recently announced public-private partnership between the pharmaceutical industry and the National Institutes of Health (NIH), which aims to support the development of non-addictive pain treatments.

November 21, 2017 | Daily News

FDA published final guidance on Tuesday (Nov. 21) that lays out how the agency will evaluate generic abuse-deterrent formulations (ADFs) of oral opioids and includes recommendations of the types of studies sponsors should conduct to show the generic ADF is no less abuse-deterrent than its reference listed drug (RLD).

November 20, 2017 | Daily News

The White House Council of Economic Advisors (CEA) announced Monday (Nov. 20) that the U.S. government has underestimated the cost of the opioid crisis, and that in 2015 the economic cost was $504 billion, or over six times more than the most recently estimated cost of the epidemic.

November 16, 2017 | Daily News

CMS is taking steps that would let Medicare Part D plan sponsors establish drug management programs for beneficiaries considered at risk for abuse of drugs identified as frequently abused under the Comprehensive Addiction and Recovery Act (CARA).

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