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Opioids

November 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb tried to assure a National Academies of Sciences, Engineering and Medicine (NASEM) committee that while the agency plans to develop and publish prescribing guidelines for acute pain, the agency does not intend to regulate the practice of medicine.

November 13, 2018 | Daily News

CMS will give states more leeway to cover inpatient treatment for serious mental illnesses, just as the agency has been doing for inpatient treatment of substance use disorders, HHS Secretary Alex Azar announced Tuesday (Nov. 13).

November 13, 2018 | Daily News

A leading public health advocate official is hopeful the incoming Democratic-led House will investigate FDA’s controversial approval of the sufentanil drug DSUVIA.

November 07, 2018 |

With Democrats taking control of the House, Rep. Frank Pallone (D-NJ) is highly expected to chair the powerful Energy & Commerce Committee, and, although he comes from a pharmaceutical-heavy district, he told Inside Health Policy prior to the election results that tackling high drug prices would be a top priority as would overseeing the administration's health care agenda.

November 07, 2018 | Daily News

With Democrats taking control of the House, Rep. Frank Pallone (D-NJ) is highly expected to chair the powerful Energy & Commerce Committee, and, although he comes from a pharmaceutical-heavy district, he told Inside Health Policy prior to the election results that tackling high drug prices would be a top priority as would overseeing the administration's health care agenda.

November 07, 2018 | Daily News

With a Democratic takeover of the House, the powerful Energy & Commerce Committee will experience leadership and priority shifts. A former congressional aide told Inside Health Policy that Democrats may use the opportunity to push the Creating and Restoring Access to Equivalent Samples (CREATES) Act, seek funding options for opioid-related initiatives, focus more on cosmetics legislation and revisit laboratory-developed test (LDT) legislation.

November 02, 2018 | Daily News

Despite opposition from public health advocacy groups and the chair of one of its own advisory committees, FDA on Friday (Nov. 2) approved a new sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl, while promising to revisit how it reviews new opioids moving forward.

November 02, 2018 | Daily News

FDA’s psychopharmacologic drugs and drug safety advisory committees, in a joint meeting on Thursday (Nov. 1). voted against approval of a proposed new opioid combination drug indicated to treat major depressive disorder.

November 02, 2018 | Daily News

A new relationship between FDA and the Department of Defense (DOD) went official Friday (Nov. 2) with the announcement of a memorandum of agreement (MOU) that will formalize a framework agreed upon in January, under which FDA will work with DOD to accelerate access to medical products for the military.

October 29, 2018 | Daily News

CMS told states they do not need to defray the costs of new benefits that may be included in a revised essential health benefit (EHB) benchmark plan unless the coverage has been legislatively mandated, and encouraged states to implement revisions that would better address the opioid epidemic.

October 29, 2018 | Daily News

In a recent report, the Institute for Clinical Economic Review (ICER) determines that extended-release formulations of medications used to treat opioid use disorder cost much more than generic buprenorphine/naloxone while providing only marginal clinical benefit.

October 25, 2018 | Daily News

Two California men have pleaded guilty to conspiring to defraud Affordable Care Act plans in at least 12 states by enrolling people in coverage and transporting them to expensive drug treatment facilities in California that paid referral and other fees, the Department of Justice announced.

October 24, 2018 | Daily News

President Donald Trump on Wednesday (Oct. 24) signed into law the massive bicameral package of opioid legislation, which the Senate passed Oct. 3.

October 23, 2018 | Daily News

FDA will ask two of its advisory committees to weigh in on expanding the availability of naloxone for use in the community during a two-day meeting Dec. 17 and 18, the agency announced Tuesday (Oct. 23).

October 23, 2018 | Daily News

The head of FDA's anesthetic and analgesic advisory committee has joined consumer group Public Citizen in urging FDA to reject approval of AcelRx's DSUVIA, a sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl.

October 19, 2018 | Daily News

HHS Secretary Alex Azar touted the agency's Regulatory Sprint to Coordinated Care on Wednesday (Oct. 17), including upcoming work on 42 CFR Part 2 privacy requirements, and the administration’s fall unified agenda indicates the Substance Abuse and Mental Health Services Administration intends to publish a proposed rule on the privacy requirements next year.

October 19, 2018 | Daily News

FDA wants to help health care providers better understand the different levels of potency across opioid medications, FDA Commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 |

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 | Daily News

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

October 17, 2018 | Daily News

Deputy Attorney General Rod Rosenstein praised the recently-passed opioid bill and said the Department of Justice is beefing up criminal prosecutions and civil penalties against over-prescribers of opioids and illegal distributors of synthetic opioids.

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