FDA announces policy shift to encourage new opioid addiction treatments
pharmafile | August 7, 2018 | News story | Manufacturing and Production | FDA, deaths, opioid crisis, overdose, policy
The US Food and Drug Administration (FDA) have announced that it is altering the way it evaluates a drug’s ability to treat opioid addiction as part of a move to encourage the development and approval of new opioid addiction treatments.
While currently the effectiveness of a potential treatment for opioid addiction is measured through its ability to reduce drug use, the shift in policy will mean that other factors will now be considered. New policy will take a drug’s ability to reduce the potential for overdose or prevent the transmission of infectious diseases into account during the regulatory process.
“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 shift in policy has come as the Trump administration places focus on what Donald Trump has called a ‘national shame’ and a ‘public health emergency’.
Health and Human Services Secretary Alex Azar commented that: “The Trump Administration is pursuing every opportunity to address our country’s opioid epidemic and support patients struggling with opioid use disorder.”
He noted that: “The FDA’s new guidance’s 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.”
Gottlieb gave final comment on the policy shift in calling it an “important step in fostering the development of new treatment options.”
Louis Goss
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