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Medicines regulation

FDA announces sweeping review of policies related to opioid drugs

Regulator announces review after figures show opioid overdose is now the leading cause of death by injury in the United States.

The US drugs safety regulator, the FDA, has launched a review into its policies involving opioid drugs, prompted by figures showing that overdose from an opioid prescription drug or illicit drug is now the leading cause of death by injury in the US

Source: Ed Rooney / Alamy Stock Photo

Figures show that overdose from an opioid drug is now the leading cause of death by injury in the United States

The US Food and Drug Administration (FDA) has launched a review into its policies involving opioid drugs.

The move by the US drugs safety regulator was prompted by latest figures showing that overdose from an opioid prescription drug or illicit drug, such as heroin, is now the leading cause of death by injury in the United States — overtaking motor vehicle accidents.

The review will be wide ranging, including a fresh look at the risk-benefit model the FDA uses when it assesses new opioid drugs, ensuring that it considers their wider impact on public health.

The FDA also intends to develop a framework for paediatric opioid labelling and will consider changing existing safety warnings and labels on immediate-release opioid medications.

The review will look at how the FDA can encourage the development of abuse-deterrent formulations of opioid products and how it can support alternative treatments for pain management. It plans to seek advice from experts in pain management and drug abuse from outside the agency to inform its findings.

The FDA has pledged to establish an independent expert advisory committee when it considers approving any new opioid drug that does not contain abuse-deterrent properties.

Robert Califf, pictured, FDA’s deputy commissioner for medical products and tobacco

Source: Michael J. Ermarth / FDA

Robert Califf, the FDA’s deputy commissioner for medical products and tobacco, announced the review into the regulator’s policies on opioids

The review was announced by Robert Califf, the FDA’s deputy commissioner for medical products and tobacco. “We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” he says. “Things are getting worse… with the epidemic of opioid misuse, abuse and dependence. It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

The review comes at the same time as the FDA asking drug companies to generate post-marketing data on the long-term impact of using long-acting opioid pain killers. It predicts these new data will help increase the understanding of the known serious risks of opioid misuse, abuse, overdose and death.

Sylvia M Burwell, pictured, US health and human services secretary

Source: United States Department of Health and Human Services

The US health and human services secretary Sylvia Burwell has endorsed the FDA’s review

The review has been endorsed by the US health and human services secretary Sylvia Burwell. “The FDA is a vital component in combating this epidemic,” she says, adding that the department and federal governments are “united in aggressively addressing this public health crisis”.

Roger Knaggs, specialist pharmacist inanaesthesia and pain management at Nottingham University Hospitals NHS Trust, says the review shows that the regulator is taking the issue seriously.

“There has been a large increase in opioid-related deaths in the United States at the same time as there has been a very large increase in opioid prescribing,” he says.

Knaggs adds that there has been an increase in opioid prescribing in the UK and other European countries, but the rate of increase has been less than in the United States. “The number of opioid related deaths — as recorded on death certificates — has remained relatively low in the UK,” he says, adding that differences in healthcare provision may explain this.

The UK’s drug safety regulator, the Medicines and Healthcare products Regulatory Agency (MRHA), says it is aware of the FDA’s review and is watching it with interest.“We will carefully consider the findings to see what implications they have for UK public health,” a spokesperson for the MHRA says. “The available evidence suggests that levels of abuse of opioid medication in the UK are not as high as in the United States.”

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200686

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Supplementary images

  • The US drugs safety regulator, the FDA, has launched a review into its policies involving opioid drugs, prompted by figures showing that overdose from an opioid prescription drug or illicit drug is now the leading cause of death by injury in the US
  • Robert Califf, pictured, FDA’s deputy commissioner for medical products and tobacco
  • Sylvia M Burwell, pictured, US health and human services secretary

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