FDA will broaden how it evaluates new addiction treatment drugs

The Food and Drug Administration on Monday announced a shift in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments.

Now, rather than merely examining whether a potential treatment reduces opioid use, the agency will consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases.

“We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement.

The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment.

MAT, coupled with psychosocial counseling, is widely acknowledged to be the standard of care in treating opioid addiction.

Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said MAT is vastly underutilized, calling for expanded access to existing options and the development of more drugs beyond the existing three.

In its guidance, the FDA said encouraging drug developers to consider outcomes beyond drug use could yield significant health benefits.

The many outcomes Gottlieb cited included mortality (both overall and from drug overdoses) and disease transmission, given the many communities that have seen outbreaks of HIV/AIDS and hepatitis concurrent with increased rates of injection drug use.

“The FDA’s new guidances have the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better chance at recovery,” health secretary Alex Azar said in a statement.

Despite early missteps in the way some officials, like former health secretary Tom Price, referred to MAT, the Trump administration has long emphasized more evidence-based treatment as part of its means of treating opioid addiction.

But the topic has also led to some controversy in Washington. The White House recently name-checked  a single drug, Vivitrol, a form of naltrexone manufactured by Alkermes, in a strategy document — preferential treatment that addiction experts said could hamstring doctors who should be able to consider all available treatment options. On Capitol Hill, lawmakers spent much of June battling over whether to expand access to buprenorphine, a provision that eventually became part of a major House bill.

The Senate is also expected to make MAT a key element of its response to the opioid crisis, but it remains unclear whether it will consider legislation on the opioid crisis prior to November’s midterm elections.

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