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Opioids

May 09, 2019 | Daily News

The Government Accountability Office (GAO) said it still hasn’t received documents from the White House Office of National Drug Control Policy (ONDCP) needed to adequately assess the administration’s national drug policy strategy, while some House Democrats said the goals outlined by the drug control office on medication-assisted treatment (MAT) are too modest.

May 07, 2019 | Daily News

States can receive additional federal funding to extend the duration of some Medicaid health homes designed to treat people with substance use disorders, CMS said Tuesday (May 7).

May 06, 2019 | Daily News

The White House Office of National Drug Control Policy (ONDCP) said Friday (May 3) that its national drug policy strategy will reduce drug overdose deaths by 15% in five years, two months after a Government Accountability Office (GAO) report said the strategy lacked key information.

May 01, 2019 | Daily News

The White House Council of Economic Advisers says falling out-of-pocket prices for opioids could explain between 31% and 83% of the growth in opioid overdose deaths between 2001 and 2010, and the council’s report tied that drop in costs to more government subsidization of the drugs through Medicare Part D and the entry of generics in the market.

April 26, 2019 | Daily News

FDA is convening two of its advisory committees to discuss safety concerns and clinical usefulness of higher-strength and higher daily doses of opioids during a meeting slated for June 11, the agency announced Friday (April 26).

April 26, 2019 | Daily News

FDA launched an educational campaign to help consumers understand how to dispose of unused opioid medications in their homes.

April 19, 2019 | Daily News

FDA on Friday (April 19) approved the first generic naloxone nasal spray, commonly known as Narcan, for use in a community setting by people who do not have medical training.

April 10, 2019 | Daily News

FDA is requiring changes to the prescribing information for all opioid analgesic medicines used in the outpatient setting to provide more information about how health care providers can safely decrease the dose in patients who are physically dependent on opioids, the agency announced Tuesday (April 9).

April 05, 2019 | Daily News

FDA and Customs and Border Protection (CBP) signed an agreement Thursday (April 4) to expand how information is shared between the two agencies and coordinate shared space to target entry of illicit drugs coming into the country through international mail facilities (IMFs).

April 03, 2019 | Daily News

Reps. Markwayne Mullin (R-OK) and Earl Blumenauer (D-OR) reintroduced anticipated bipartisan legislation Wednesday (April 3) that would align the strict privacy scheme for substance abuse treatment records, 42 CFR Part 2, with the less-stringent Health Insurance Portability and Accountability Act (HIPAA).

April 01, 2019 | Daily News

CMS on Monday (April 1) finalized its call for Medicare Advantage and Part D plans to do more to reduce opioid dependence among beneficiaries and expand access to naloxone, the opioid overdose reversal drug, by reducing beneficiaries’ costs through new tiering policies, among other possible actions.

March 29, 2019 | Daily News

Outgoing FDA Commissioner Scott Gottlieb suggested Congress consider establishing incentives, including market exclusivity, to help drive development of safer pain medications.

March 29, 2019 | Daily News

New York state has filed a lawsuit against opioid makers and distributors and the Sackler family, which founded Purdue Pharma and developed OxyContin, for false and deceptive marketing of opioids that the state alleges helped spur the opioid epidemic, New York Attorney General Letitia James announced Thursday (March 28).

March 26, 2019 | Daily News

Purdue Pharma, the manufacturer of OxyContin, has settled with the state of Oklahoma for $270 million in the state’s opioid litigation against multiple opioid makers over their allegedly deceptive marketing practices.

March 21, 2019 | Daily News

A prominent consumer advocacy group and an FDA advisory committee chair are calling for FDA drug center chef Janet Woodcock to step down from her post in order to clear a path for the agency to revamp its regulation of opioids and implement recommendations made in 2017 by the National Academies of Sciences, Engineering, and Medicine.

March 21, 2019 | Daily News

A prominent consumer advocacy group and an FDA advisory committee chair filed a citizen petition on Thursday (March 21) demanding FDA slap an immediate moratorium on the approval of new opioids until it revamps its regulation and review of new opioids as recommended by the National Academies of Sciences, Engineering, and Medicine in 2017.

March 11, 2019 | Daily News

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

March 07, 2019 | Daily News

The director of the White House Office of National Drug Control Policy (ONDCP) agreed to provide more information to the chair of the House Oversight & Reform Committee on the office’s drug policy strategy after a Government Accountability Office report released Thursday (March 7) found that the strategy lacked required information, such as measurements of performance goals.

March 06, 2019 | Daily News

Specialists in the fields of addiction and mental health urged Congress on Wednesday (March 6) to give more federal money to providers on the front lines of the opioid crisis -- including by funding several programs that were authorized in last year’s major opioid bill.

March 06, 2019 | Daily News

Provider groups and insurance plans applauded a CMS proposal to increase access to the opioid overdose reversal drug naloxone included in the agency’s 2020 draft Medicare Advantage and Part D call letter, but some groups called for CMS to reconsider a proposal on co-prescribing the drug with opioid prescriptions, saying that decision should be left between a provider and patient.

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