National Academies of Sciences Call for Fundamental Changes in FDA Opioid Approvals

National Academies of Sciences Call for Fundamental Changes in FDA Opioid Approvals

It will take years of sustained, coordinated efforts to "contain and reverse" the prescription and illicit opioids epidemic, says a new, far-reaching report to the Food and Drug Administration from the National Academies of Sciences, Engineering, and Medicine.

Contrary to current thinking, however, the report suggests that if its recommendations are followed, significant reductions in the epidemic can be achieved without depriving legitimate pain patients needed opioid analgesics.

"It is possible," says the report, "to stem the still-escalating prevalence of opioid use disorder and other opioid-related harms without foreclosing access to opioids for patients suffering from pain whose providers have prescribed these drugs responsibly."

Fundamental changes in FDA approvals process

The study begins by recommending fundamental changes in the FDA's opioids approvals process. "The FDA traditionally has taken a product-specific approach to drug approval decisions by focusing on the data generated and submitted by a drug's manufacturer and balancing the benefits against the known risks to the individual patient," the report says. "While this approach works well in most cases, it is necessary to view regulatory oversight of opioid medications differently from that of other drugs, because these medications can have a number of consequences not only at the individual level but also at the household and societal levels. Therefore, the FDA should incorporate public health considerations into opioid-related regulatory decisions, including during the clinical development stage."

Changes at the FDA are just the beginning. Numerous programs are recommended for other federal agencies, state and local governments and health-related organizations, including:

  • Complete FDA review of the safety and effectiveness of all approved opioids;
  • States should convene a public-private partnership to create "any-day" pharmacy drug take-back programs to replace the occasional take-back events;
  • Insurance companies and other payers should create reimbursement models that support evidence-based, cost-effective non-drug treatments for pain as well as drugs;
  • Health and Human Services (HHS) with states need to study how prescription drug monitoring programs can be better leveraged to track opioid prescribing and dispensing information;
  • National Institutes of Health, Substance Abuse and Mental Health Services Administration, U.S. Department of Veterans Affairs and industry should invest in research that examines "the nature of pain and opioid use disorder" as well as develop new, non-addictive treatments for pain.

Fundamental changes in physician and patent education

The report calls for a "fundamental shift in the nation's approach to prescribing practices and improved awareness of the risks and benefits of opioids" through enhanced education for the public as well as health professionals.

An evaluation of the impact and cost of an education program that raises awareness about the risks and benefits of prescription opioids is required for both the general public and pain patients.

Pain-related education should be mandated for all health professionals who treat pain, including basic training in the treatment of opioid use disorder. Prescribers and pharmacists should be trained to recognize and counsel patients who are at risk for opioid use disorder or overdose.

"Restrictions on lawful access to prescription opioids could have other unintended effects, and any policy designed to curtail legal access to them will inevitably drive some people toward the illegal market," the report says. Any strategy for "reducing lawful access to opioids should be coupled with an investment in treatment for the millions who have opioid use disorder."

"The broad reach of the epidemic has blurred the formerly distinct social boundary between prescribed opioids and illegally manufactured ones, such as heroin," said committee chair Richard J. Bonnie, Harrison Foundation Professor of Medicine and Law and director of the Institute of Law, Psychiatry, and Public Policy at the University of Virginia in Charlottesville. "This report provides an action plan directed particularly at the health professions and government agencies responsible for regulating them. This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing. We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel."

You can download a free PDF copy of Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.

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