FDA top officials call for sweeping review of agency opioids policies

In response to the opioid abuse epidemic, Dr. Robert Califf, the FDA’s deputy commissioner for medical products and tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications.

The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. As one of the cornerstones, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the FDA has already asked the National Academy of Medicine to help develop a framework for opioid review, approval and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.

In addition, the FDA will convene independent advisory committees made up of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties. The FDA will also convene a meeting of its standing Pediatric Advisory Committee to make recommendations regarding a framework for pediatric opioid labeling and use of opioid pain medications in the pediatric population.

The FDA is also strengthening the requirements for drug companies to generate post-market data on the long-term impact of using ER/LA opioids. The agency expects this to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death.

The evidence-based initiative focuses on three promising areas: informing opioid prescribing practices; increasing the use of naloxone, building on the FDA’s recent approvals of injectable and intranasal naloxone; and using medication-assisted treatment to move people out of opioid addiction. The FDA’s call to action is also supportive of the Centers for Disease Control and Prevention’s current work on guidelines for prescribing of opioids for the treatment of chronic pain outside of end of life care.

Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illicit drug heroin.

Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes.

Image credit: Shutterstock.com/ Davydenko Yuliia


A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

Brilinta approved in US to reduce the risk of first heart attack or stroke

AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with...

GSK to manufacture 1bn doses of pandemic vaccine

GlaxoSmithKline (GSK) is aiming to manufacture one billion doses of its pandemic vaccine adjuvant system, in 2021, to support the development of multiple adjuvanted...

Chimeron Bio & NCBID to develop COVID-19 vaccine

RNA therapeutics company, Chimeron Bio, and George Mason University’s National Center for Biodefense and Infectious Diseases (NCBID), will together develop a COVID-19 vaccine. The vaccine...

AbCellera raises $105m to advance antibody drug discovery platform

AbCellera has closed a $105 million Series B financing to further advance its antibody drug discovery platform. The financing was led by OrbiMed and current...

Novavax expands large-scale manufacturing capacity

Novavax, a late-stage biotech developing next-gen vaccines for serious infectious diseases, has expanded its large-scale manufacturing capacity with the $167 million acquisition of Praha...

Related news

Emergent joins partnership for COVID-19 vaccine development & manufacturing

Emergent BioSolutions has been issued a task order under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to deploy its...

Brilinta approved in US to reduce the risk of first heart attack or stroke

AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with...

GSK to manufacture 1bn doses of pandemic vaccine

GlaxoSmithKline (GSK) is aiming to manufacture one billion doses of its pandemic vaccine adjuvant system, in 2021, to support the development of multiple adjuvanted...

Chimeron Bio & NCBID to develop COVID-19 vaccine

RNA therapeutics company, Chimeron Bio, and George Mason University’s National Center for Biodefense and Infectious Diseases (NCBID), will together develop a COVID-19 vaccine. The vaccine...