Gottlieb Seeks New Comparative Approval Standard for Opioids

Regulatory NewsRegulatory News | 28 March 2019 |  By 

With just a week left before he departs from the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb on Thursday told the Senate Appropriations Committee that his agency is interested in Congress creating a new standard for opioid approvals whereby those seeking approval would be compared to opioids already on the market.

“For this to work, the FDA believes that there should be a premarket demonstration that a new opioid is superior to an already-approved opioid or opioid-containing drug for the same general indication. The standard should be that a new opioid or opioid-containing drug provides a significant advantage relative to an already-approved opioid or opioid-containing drug for the same general indication in terms of greater efficacy or greater safety,” he said.

Drugs that meet this new standard could receive breakthrough or some other new designation to further prioritize their review. “Eventually, Congress could consider how other incentives, including exclusivity periods, might help drive development toward drugs with safer attributes,” Gottlieb added.

While acknowledging that opioids need to be treated differently from other products, he also said FDA is working to implement different provisions from the Support Act, including new requirements for longer effectiveness studies and other authorities that allow FDA to require certain packaging to be made available for opioids that pose a serious risk of abuse or overdose.

“The question is long-term safety when these drugs are used chronically, in particular whether efficacy declines and if that creates safety issues,” Gottlieb said.

But on the question of whether any company is close to bringing a non-opioid painkiller to market, Gottlieb said they’re in the early stages of development and it’s difficult to predict how quickly such a product would come to market.

He also did not seem to think the influx of illicit opioids was under control. “I don’t know that I can say we have a handle on it or an understanding of the full scope,” he added.

In addition to the opioids discussion, Sen. Patrick Leahy (D-VT) asked Gottlieb about the agency’s framework for approving biosimilar insulins, which is shifting in 2020 as products approved under new drug applications are transitioned to biologics licenses.

Gottlieb said he thought that under the new biosimilars pathway, “we’ll see much more competition” for insulins, as it will be easier to get to market and compete as interchangeable products. He acknowledged there may be one or two applications that get caught and have to be resubmitted because of the shift, but he insisted there will be “vigorous activity under the new framework.”

He also said he hopes Congress would reauthorize the important biosimilar approval pathway, which is part of the Affordable Care Act, if the ACA were invalidated.

In his written testimony, Gottlieb also discussed transforming medical device safety and cybersecurity, medical countermeasures and drug compounding.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy