On August 31, 2016, the U.S. Food and Drug Administration (“FDA”) announced class-wide drug labeling changes aimed at providing better information to health care providers and patients. FDA’s guidance warns of the risks associated with combined use of certain opioid
On July 13, 2016, the Senate passed by 92-2 vote the Comprehensive Addiction and Recovery Act of 2016 (S. 524), a comprehensive set of 18 bills targeting the opioid crisis, which bill the U.S. House of Representatives approved in a 407-5 vote on July 8, 2016.
Last week, CMS posted the 2015 Open Payments data to its website, as well as updated payment records for 2013 and 2014. Overall, manufacturers reported $7.52 billion in payments and ownership interests to 618,931 physicians and 1,116 teaching hospitals in 2015. Nearly 1,500 companies reported making payments in 2015, comprising a total 11.9 million records. Although the total number of records and amounts of payment are comparable from 2014 to 2015, there are shifts in the reporting of the nature of payments.
On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act. MAT involves the use of medication in combination with certain behavioral health interventions to provide a comprehensive, individualized approach to opioid use disorder treatment.
On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.
During the week ending May 13, 2016, the U.S. House of Representatives approved a comprehensive set of 18 bills aimed at curbing the opioid epidemic. The largest of these bills, the Comprehensive Opioid Abuse Reduction Act of 2016 (H.R. 5046), passed by a 413-5 vote in the House on May 12, 2016. This bill authorizes US $103 million dollars in grant funding for fiscal years 2017 through 2021, and makes the U.S. Department of Justice (DOJ) responsible for administering grants to state, local, and tribal governments to provide a range of opioid abuse services. These services include developing and expanding existing programs to combat opioid abuse, training first responders in administering opioid overdose reversal medication, and providing dedicated opioid treatment and prevention services for veterans. In March 2016, the Senate passed a similar measure, titled the Comprehensive Addiction and Recovery Act of 2016 (S. 524), which authorizes the Attorney General to award similar grants.
On March 22, 2016, the US Food and Drug Administration (FDA) issued a safety announcement that includes required labeling changes for immediate-release (IR) opioid pain medication (and the entire class of opioid drugs) and recommendations and information for patients and health care professionals. The FDA’s new safety warnings and required labeling changes come shortly after the Senate unanimously passed Senate Bill 483 (114th Congress) on March 17, 2016 requiring greater federal oversight of opioid prescribing practices.
On March 17, 2016, the Senate passed two independent bills in response to growing concerns with the Zika virus outbreak and current opioid painkiller prescribing practices. The Senate bill addressing the Zika virus aims to fuel the development of countermeasures
On March 15, 2016, in response to an epidemic of opioid overdose deaths, the Centers for Disease Control and Prevention (CDC) issued guidance intended to assist primary care providers in prescribing opioid medications for chronic pain (pain lasting greater than