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FDA commissioner Scott Gottlieb says that more rigorous approval process would be unique to opioids

Published on 12/11/18 at 11:13am

Food and Drug Administration (FDA) commissioner Scott Gottlieb has said that if a more rigorous approval process is introduced for opioids, the higher standards will be ‘unique’ to opioids.

“I don’t think this same kind of standard would apply in other therapeutic areas. I think opioids are unique,” Gottlieb said.

The suggestion comes in the midst of a debate as to whether new drugs should be approved or rejected within the context of what is already available on the market. Although currently, drugs are approved only on the basis as to whether the medicine is safe and effective, this could change in regards to opioids.

The change may mean that new opioids would have to bring some distinct value to the market in order to be approved.

Gottlieb added: “I would do everything that I could from a policy standpoint ... to make it explicit that this was narrowly tailored to opioids for public health reasons”

Louis Goss

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