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Opioids

July 16, 2019 | Daily News

Lawmakers and federal agencies tasked with monitoring illicit drug flow, including FDA and Customs and Border Protection, pinpointed a lack of data sharing among agencies as a challenge in combating the illicit flow of fentanyl into the United States.

July 08, 2019 | Daily News

FDA is expediting review of all generic drug applications for overdose-reversal drugs, including naloxone nasal spray, injection and auto-injector, and nalmefene injection, the agency announced Monday (July 8).

July 03, 2019 | Daily News

FDA unveiled two new guides Monday (July 1) on prescription drug and biologics labeling: One focuses on labeling of drugs and biologics that have potential for abuse and dependence, and the other addresses the content and format for the instructions for use section of labeling for drugs and biologics, and drug-device or biologic-device combination products.

June 27, 2019 | Daily News

Providers and plans are optimistic that legislation to 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) have a better chance of success after the American Medical Association opted to throw its support behind amending the privacy scheme and support from lawmakers has increased.

June 20, 2019 | Daily News

FDA wants to hear from stakeholders on whether new preapproval incentives are needed to encourage development of safer pain and addiction therapies at a public hearing slated for Sept. 17.

June 20, 2019 | Daily News

FDA will take into account a proposed opioid’s broader public health effects, including on non-users, and look at how the product compares in safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20).

June 13, 2019 | Daily News

As part of their investigation into the dangers of illicit fentanyl, much of which comes from China, a bipartisan group of House Energy & Commerce Committee leaders wrote to FDA Acting Commissioner Ned Sharpless and heads of five other federal agencies to request briefings on the effect the opioid epidemic is having on public health and on their solutions for stopping the flow of illicit fentanyl into the United States.

June 12, 2019 | Daily News

CMS Administrator Seema Verma and senior advisor to the president Kellyanne Conway touted efforts by CMS and the Trump administration to improve maternal health in rural areas by extending Medicaid coverage for postpartum women with substance use disorders, but advocates said Medicaid coverage should be extended for all postpartum women and more states should expand Medicaid, speaking at a Kaiser Family Foundation event Wednesday (June 12).

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.

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