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August 09, 2018 | Daily News

The American Cancer Society Cancer Action Network (ACS CAN) says the recent spate of state legislation and policy proposals responding to the opioid crisis are creating barriers to treatment and relief for cancer patients and others with chronic pain.

August 06, 2018 | Daily News

FDA in a draft guidance published Monday (Aug. 6) lays out new types of endpoints -- beyond complete abstinence from drug use -- that can be used to develop and assess the efficacy of medication-assisted treatment (MAT) for opioid use disorder and be included on product labeling.

August 03, 2018 | Daily News

Key questions loom regarding FDA's plan to offer select sponsors of opioid treatment and prevention devices special treatment in the review process, including what reimbursement pathways may be available, how many sponsors FDA will select and how the streamline review approach will differ from the breakthrough designation.

July 13, 2018 | Daily News

Chronic pain patients, patient representatives and caregivers lambasted the Centers for Disease Control and Prevention’s opioid prescribing guidelines at an FDA meeting Monday (July 9), saying the guidelines have caused doctors to be reluctant to prescribe opioids and have led to patients being involuntarily weaned off much-needed medications.

July 13, 2018 | Daily News

The chronic pain patient community argued that policies to lower opioid prescribing rates are having a negative effect on patients, speaking at an FDA meeting Monday (July 9).

July 13, 2018 | Daily News

FDA will hold a two-day scientific conference in September to discuss how sex and gender influence opioid and tobacco misuse and abuse, the agency announced in the Federal Register Friday (July 13).

July 06, 2018 | Daily News

While tech companies are uniquely positioned to positively affect public health with regard to the opioid crisis, the industry remains somewhat hesitant to take on the role as content police, one policy expert told Inside Health Policy.

July 05, 2018 | Daily News

Facebook delivered a 748-page document to House lawmakers describing its current process for taking down flagged content and detailing its efforts to ban certain search terms and more quickly remove inappropriate content, but also said its response to the opioid crisis is a work in progress -- a message that echoes Facebook Co-founder and CEO Mark Zuckerberg's comments during a recent Energy & Commerce Committee hearing.

June 27, 2018 | Daily News

FDA on Wednesday (June 27) convened a summit with other federal agencies and more than 15 internet companies, patient advocacy organizations and universities to talk about how to stem the online sale and purchase of illicit opioids.

June 26, 2018 | Daily News

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee on Tuesday (June 26) voted 14-3 that efficacy, safety and risk-benefit data for a new oxycodone medicine -- Pain Therapeutics’ Remoxy Extended Release (ER) -- did not support the drug’s approval.

June 22, 2018 | Daily News

The House overwhelmingly approved a legislative package Friday (June 22) aimed at combating the nation’s opioid crisis, concluding a two-week bonanza of House votes on opioid-related measures that include expanding access to medication-assisted treatment, cracking down on over-prescribers of opioids, increasing telehealth services for treatment of substance use disorder, and encouraging non-opioid pain management techniques.

June 20, 2018 | Daily News

The House of Representatives voted Wednesday (June 20) to allow Medicaid to pay for some substance abuse treatment in large inpatient facilities and to ease privacy restrictions for medical records containing information about substance abuse.

June 20, 2018 | Daily News

The House on Tuesday (June 19) voted 342-13 to pass a bill that would direct FDA to work with drug manufacturers to establish programs to return or dispose of unused Schedule II and III substances.

June 19, 2018 | Daily News

After initially being blocked by House Republican committee leaders, a proposal to expand the authority of non-physicians to prescribe buprenorphine ended up in the umbrella legislation on opioids that the House will vote on this week because the Drug Enforcement Agency dropped its objections to the proposal, according to a congressional aide.

June 18, 2018 | Daily News

The House of Representatives will continue voting this week on a trove of bills aimed at alleviating the opioid crisis, including controversial measures on Medicaid payments for inpatient treatment, medical privacy for people with substance use disorders and expanded prescribing authority for buprenorphine.

June 13, 2018 | Daily News

The House passed a bill Wednesday (June 13) strengthening FDA’s authority over international mail facilities (IMFs), which the bill’s sponsors say will help stymie the flow of illicit opioids and other drugs being imported into the United States.

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.