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Opioids

June 12, 2018 | Daily News

The House of Representatives passed 25 bills on Tuesday (June 12) that lawmakers say will help with the nationwide opioid crisis through a wide range of methods, from enhancing HHS and FDA’s seizure authority over imported drugs to amending the Public Health Service Act to provide for regional centers of excellence in substance-use disorder education.

June 12, 2018 | Daily News

The Senate Finance Committee unanimously approved a package of opioid-related legislation Tuesday (June 12) that would make modest tweaks to Medicare and Medicaid in hopes of reducing opioid abuse in those programs.

June 11, 2018 | Daily News

CMS issued guidance to states Monday (June 11) on ways Medicaid can treat infants who are born exposed to opioids and how states can use enhanced federal match rates to expand prescription monitoring and other health technology in their efforts to combat opioid abuse among adults.

June 11, 2018 | Daily News

The Senate Finance Committee will mark up a legislative package Tuesday (June 12) intended to reduce opioid abuse in Medicare and Medicaid. The package released by committee Chair Orrin Hatch (R-UT) and ranking Democrat Ron Wyden (OR) includes measures to identify over-prescribing of opioids, increase awareness of alternative pain management, expand coverage of telehealth services for substance use disorders and bar lifetime limits on medication-assisted treatment in Medicaid.

June 11, 2018 | Daily News

The National Institutes of Health plans to ask the National Academies of Sciences, Engineering and Medicine to study the effectiveness of medication-assisted treatment for opioid use disorder, heeding a request from Rep. Frank Pallone (D-NJ).

June 11, 2018 | Daily News

Top House Energy & Commerce members from both parties raised concerns FDA is not following through on its plan to use $94 million from Congress to double down on efforts to keep illegal opioids from entering the United States through international mail facilities.

June 07, 2018 | Daily News

The White House Office of National Drug Control Policy, the Truth Initiative and the Ad Council have launched a national opioid education campaign targeted to those between 18 and 24 years old.

June 07, 2018 | Daily News

The Senate Appropriations Committee is pressing FDA to consider taking ultra-high dosage opioids off the market after conducting a review of public health risks. The move comes three months after the agency punted on a citizen petition request that the products be removed, with FDA telling the petitioners it needed more time to study the issue.

June 05, 2018 | Daily News

FDA sent warning letters to nine online networks operating 53 websites demanding they stop illegally marketing misbranded and unapproved drugs, specifically opioids, the agency announced Tuesday (June 5).

June 04, 2018 | Daily News

Senate appropriators are calling on FDA to develop a framework to add information about co-prescribing opioids with naloxone to opioid labels and Risk Evaluation and Mitigation Strategies information.

May 31, 2018 | Daily News

FDA needs to tread carefully as it tackles the opioid epidemic by focusing on lowering misuse and abuse of prescription drugs to ensure it doesn't in turn cause people to turn to alternative substances and spark a new wave of addiction, FDA Commissioner Scott Gottlieb, drug center Director Janet Woodcock and Deputy Center Director for Regulatory Programs Douglas Throckmorton write in a New England Journal of Medicine article published Wednesday (May 30).

May 30, 2018 | Daily News

FDA is offering special incentives in its quest for medical and digital health device developers to submit proposals for “novel solutions” for detecting, treating and preventing addiction and for addressing diversion and treating pain, the agency said in a press announcement Wednesday (May 30).

May 30, 2018 | Daily News

The Senate Finance Committee in the coming weeks will mark up more than a dozen bills aimed at reducing opioid abuse in Medicare and Medicaid, including several that resemble measures recently approved by the two House committees working on opioid legislation.

May 30, 2018 | Daily News

Hospitals and addiction treatment groups back a bipartisan, bicameral bill that would increase the number of Medicare-funded graduate medical education residency slots at hospitals that have or are establishing approved residency programs in addiction medicine, addiction psychiatry or pain management.

May 25, 2018 | Daily News

The Senate Judiciary Committee on Thursday (May 24) voted to send five opioid-related bills to the Senate floor, including a measure that would require the Drug Enforcement Administration (DEA) to consider diversion, abuse and other public health impacts of opioids when setting annual production quotas for manufacturers.

May 24, 2018 | Daily News

FDA Commissioner Scott Gottlieb is inviting internet stakeholders, including senior executives of major search engines, social media platforms, domain names registries and online marketplaces, to an opioid summit on June 27 to discuss ways to reduce illegal online opioid sales.

May 22, 2018 | Daily News

A Senate Appropriations subcommittee on Tuesday (May 22) voted unanimously to send to the full committee a fiscal 2019 FDA funding bill that appears to give the agency $163 million more than its current level but still less than requested by the administration, coming after House appropriators also agreed to hike FDA spending.

May 21, 2018 | Daily News

The House Energy & Commerce Committee late last week approved an opioid bill that would give FDA authority to require postmarketing studies on controlled substances for which efficacy questions arise.

May 18, 2018 | Daily News

The House Energy & Commerce Committee approved 32 opioid-related bills on Thursday (May 17), including a bill that would weaken privacy protections for medical records containing information about substance use disorders and a watered-down version of a bill that would allow Medicaid to cover treatment for opioid use disorder in large inpatient treatment centers.

May 17, 2018 | Daily News

FDA on Wednesday (May 16) approved US WorldMeds LLC’s Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal.

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