FDA Intros New Programs to Combat the Opioid Epidemic

FDA Intros New Programs to Combat the Opioid Epidemic

The Food and Drug Administration (FDA) has introduced several new programs and advices recently, aimed squarely at combating the nation's deadly opioid epidemic.

Among the programs and advices are:

  • Prescribing guidelines
    In late August, FDA Commissioner Scott Gottlieb, M.D., announced "new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics."
  • Veterinarian advice
    The FDA also announced "important information for veterinarians to ensure they have additional context regarding the potential for people to misuse the products that they are prescribing to their animal patients."
  • Innovative MAT drugs
    Earlier in the month, the agency released "new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD)."
  • Patient perspectives
    Early in July, the agency kicked off this round of opioid epidemic projects with a public meeting on "patient-focused drug development for chronic pain... to hear patient perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain."

These and other programs have evolved from the FDA's Opioid Policy Steering Committee (OPSC). Formed last year with the agency's most senior staff, it was tasked with finding new approaches to combat the epidemic.

"One overarching goal of the committee," Gottlieb said recently, "was to develop new policy solutions to reduce overall exposure to opioids, prevent new addictions, and support the development and use of better FDA-approved medications to treat those with opioid use disorder."

Among the actions recommended by the OPSC were to solicit more input from the public. In September, 2017, the FDA asked for ideas on how the agency could be better used to address the crisis. This led to a public meeting in early 2018 to gather specific input on the FDA's role in creating more appropriate opioid prescribing guidelines.

Prescribing guidelines

Many people who become addicted to opioids are first exposed to them through a prescription.

"The fact remains that there are still too many prescriptions being written for opioids," Gottlieb said in a statement. "And too many prescriptions are written for longer durations of use than are appropriate for the medical need being addressed."
To that end, the agency has asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop "evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures."

NASEM will identify and prioritize procedures and conditions associated with acute pain for which opioids are commonly prescribed. It will also study all existing guidelines, and outline new research that might be needed.

Veterinarian advice

Although it's not a major source of diversion, people continue to swipe their pet's opioids, and frequently enough to draw the attention of the FDA.

To this end, the agency has released a detailed new guideline for veterinarians, The Opioid Epidemic: What Veterinarians Need to Know. The guideline contains "important information for veterinarians to ensure they have additional context regarding the potential for people to misuse the products that they are prescribing to their animal patients," Gottlieb said.

More innovative MAT drugs

The agency has released a new draft guidance for drug companies to use to measure and demonstrate the effectiveness and benefits of new MAT drugs they might develop.

Titled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry, it can be downloaded from the FDA website (PDF).

The agency points out that it is only helpful guidelines, not policy, and represents "the current thinking of the agency on this topic."

Patient perspectives

The FDA has said that chronic pain affects 100 million US adults, impacting livelihoods and well-being while contributing to morbidity and disability nationwide. With an estimated economic impact close to $600 billion a year, chronic pain continues to be a major focal point for more effective and safer opioid prescription policies.

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