FDA Admits Past Mistakes In Handling Opioid Crisis

By Paul Gaita 03/04/19
The Food and Drug Administration addressed its missteps in handling the crisis and outlined its future plans in a new statement.
FDA commissioner Scott Gottlieb
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FDA Commissioner Scott Gottlieb issued a far-ranging statement about his agency's most recent and upcoming actions, while also addressing past missteps, in regard to the national opioid epidemic.

Noting that the FDA's previous wait-and-see policy in regard to evidence and intervention left it "a step behind a crisis that was evolving quickly," Gottlieb said in the statement that his agency will implement more effective measures to reduce exposure to opioids, including prescription and labeling changes, promotion of treatment therapies, and approval of non-dependency-forming pain treatment.

Calling the opioid crisis "a top priority" of both Secretary of Health and Human Services Alex Azar and the Trump Administration as a whole, Gottlieb wrote that faster and more decisive action will define the FDA's policy in 2019.

The rise in synthetic opioids like fentanyl and the "continued prevalence" of opioid prescriptions with overly long durations has prompted the agency to "step up its intervention," according to Gottlieb.

The commissioner also noted that the FDA's previous approach—"waiting for the accumulation of definitive evidence of harm" put them in a position of catching up to the crisis as it ravaged "vulnerable communities."

"We don't want to look back five years from now, at an even bigger crisis, with regret that there were more aggressive steps that we could have taken sooner," wrote Gottlieb. "All options are on the table."

As Gottlieb outlined in his statement, these options have included expanded information on drug labeling. Passage of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act in October 2018 has also given the agency new authority to assess and reduce dependency and misuse of opioids, including requirements for packaging on opioids and other drugs that carry a high risk of abuse or overdose.

According to the statement, FDA will issue a report on their recommendations for prescription guidelines at the end of 2019.

The FDA is also considering an option to require certain immediate-release formulations of opioids be made available in blister packages containing one- and two-day dosages, which would "comport with evidence demonstrating that a day or two of medication is sufficient" and could "reduce the overall amount of dispensed drugs available for misuse, abuse and diversion."

Gottlieb also wrote that the agency will consider a formal evaluation of prospective opioid drugs to determine its application for specific patients, and whether or not the newer application is safer or more effective for treatment than existing, non-addictive medication. The Risk Evaluation and Mitigation Strategies (REMS) program, which measures the benefits of a particular drug over its potential risks, will also be subject to review to determine if it is properly addressing such concerns.

The FDA will also prioritize the development of new and effective forms of medication-assisted treatment (MAT) to treat opioid dependency and non-addictive pain medication, and expand access to the overdose reversal drug naloxone.

The agency will also continue to partner with U.S. Customs and Border Protection to reduce the marketing and distribution of illegal opioids through national borders and through international shipping.

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.