The FDA has recently acknowledged its own need to establish a “far-reaching action plan to reassess the agency’s approach to opioid medications” in order to reduce the trend, deemed by the U.S. Department of Health and Human Services as “a serious public health issue.” Now the leading cause of accidental death in the U.S., more Americans currently die from drug overdoses annually than motor vehicle crashes, the majority of which can be linked back to opioid prescription medications such as oxycodone, hydrocodone, codeine, morphine, fentanyl, and others.

National Attention

In addition to spurring the FDA to action, Health and Human Services Secretary Sylvia Burwell identified the boundlessness of the epidemic, citing the importance of both state and federal leaders coming together to form “a coordinated and comprehensive approach to address this crisis.” President Obama has also taken part in multiple efforts to curb the issue, including his 2010 National Drug Control Strategy to address opioid use disorders and overdose, as well as an October 2015 Memorandum to Federal Departments and Agencies calling for improved prescriber training and improved access to treatment for those addicted.

Recent Court Cases Press the Issue

The limelight on opioids has also triggered debate in the political arena, as well as even deeper scrutiny by the medical and workers’ comp communities, particularly following an array of eye-opening court cases in which doctors are being held liable for opioid prescribing practices. The most recent? February 2016’s Tseng Conviction, in which a California general practitioner was sentenced 30 years to life for the prescription of unnecessary painkillers which contributed to the fatal overdose of three patients.

The FDA Proposal to Combat the Epidemic

In response to the crisis, the FDA “has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities.” Among the steps being taken…

  • Advisory committees to review new drug applications, especially for opioids without abuse-deterrent properties.
  • New warnings and safety labels to help doctors better understand risks and safe prescription practices.
  • Upholding new requirements for drug companies to provide new data on the long-term impact of opioid drugs.
  • Improved and updated CME training, including proven uses for opioids and safe prescribing practices, to decrease inappropriate prescriptions.
  • Creating/expanding access to abuse-deterrent opioid formulations (ADF) to discourage abuse by spurring innovation, as well as generic formulations, of ADF products.
  • A re-examination of the risk-benefit paradigm for opioids to include consideration of the widespread public health effects of drugs.

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