Tag archives: recommended opioid prescribing

FDA now demands its strongest black box warnings for certain opioid and other drugs

By Yvonne Puig (US) and Mark Faccenda (US) on September 1, 2016 Posted in FDA & Food Safety

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 medicines and benzodiazepines. FDA prepared a Drug Safety Communication directed to health care professionals and … Continue reading

Senate advances comprehensive opioid bill for President to sign

By Yvonne Puig (US) and Mark Faccenda (US) on July 15, 2016 Posted in News from DC, Regulatory

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.… Continue reading

2015 CMS “Open Payments” data released

By Benjamin Wallfisch (US) on July 5, 2016 Posted in Transparency

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. … Continue reading

Senators urge HHS to further expand patient access to opioid drug treatment

By Yvonne Puig (US) and Mark Faccenda (US) on June 10, 2016 Posted in News from DC, Regulatory

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 … Continue reading

FDA approves first implantable buprenorphine maintenance treatment for opioid addiction

By Yvonne Puig (US) and Mark Faccenda (US) on May 27, 2016 Posted in Regulatory

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.… Continue reading

House passes comprehensive opioid legislation in advance of negotiations with the Senate

By Yvonne Puig (US) and Mark Faccenda (US) on May 16, 2016 Posted in News from DC, Regulatory

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 … Continue reading

FDA requires new “black-box” safety warnings for opioid drugs

By Yvonne Puig (US) and Mark Faccenda (US) on March 22, 2016 Posted in FDA & Food Safety

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 … Continue reading

Senate passes critical bills for managing the Zika virus and establishing federal oversight of opioid painkillers

By Yvonne Puig (US) and Mark Faccenda (US) on March 18, 2016 Posted in News from DC, Regulatory

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 to address the Zika virus outbreak by providing for expedited US Food and Drug Administration … Continue reading

CDC releases guidance on recommended opioid prescribing

By Yvonne Puig (US) and Mark Faccenda (US) on March 15, 2016 Posted in Regulatory

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 three months or past the time of normal tissue healing). CDC clarifies that its guidance … Continue reading