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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.

May 17, 2018 | Daily News

The House Ways & Means Committee approved Wednesday (May 16) six relatively uncontroversial and bipartisan bills aimed at reducing opioid abuse in Medicare.

May 11, 2018 | Daily News

The House Ways & Means Committee will mark up legislation aimed at fighting the opioid epidemic, the committee’s leadership said Friday (May 11), while not specifying a date for what will be the third markup of significant opioid legislation by a congressional committee this spring.

May 09, 2018 | Daily News

The House Energy & Commerce Committee advanced 25 opioid-related bills Wednesday (May 9) to the House floor, along with legislation that would reauthorize FDA’s animal drug and animal generic drug user fee programs.

May 08, 2018 | Daily News

House Ways & Means health subcommittee Chair Peter Roskam (R-IL) said again on Tuesday (May 8) that he intends to advance legislation this year that would reduce regulations in Medicare, and he said that effort, along with a package of bills to address the opioid crisis, are likely to be the only health care legislation that Congress takes up this year.

May 08, 2018 | Daily News

The House Energy & Commerce health subcommittee remained divided Tuesday (May 8) over a controversial proposal that seeks to improve coordination of care in Medicare and Medicaid by loosening privacy rules that govern health records related to drug or alcohol abuse.

May 07, 2018 | Daily News

FDA may soon release a guidance on combination product reviews and announce an initiative to offer new incentives for development of devices that manage or treat patient pain, FDA Commissioner Scott Gottlieb said at a medical device conference Thursday (May 3).

May 04, 2018 | Daily News

The House Energy & Commerce Committee will mark up opioid-related legislation during two sessions held over a two-week period, with the first markup scheduled for Wednesday (May 9), the committee announced on Friday (May 4). The second markup is scheduled for May 17.

May 04, 2018 | Daily News

Baltimore health officials are urging the Trump administration to use a law, which was last considered by the Bush administration during the 2001 anthrax scare, to cut the price of the opioid-overdose drug naloxone.

May 02, 2018 | Daily News

The House Energy & Commerce health subcommittee will hold a hearing Tuesday (May 8) exclusively to consider a controversial bill that would allow providers and payers to more easily share patients’ medical records that contain information about substance use disorders.