Opioid makers could face a higher bar if FDA gets new powers

Opioid makers who want to bring new painkillers to market would have to prove their drug works better than what already exists, the FDA chief said Thursday, calling for new legal authority for the agency.

“Opioids don’t work like other drugs, and I think that’s something I’d like to see happen,” Robert M. Califf, commissioner of the Food and Drug Administration, told a Senate Committee panel. credits.

Califf’s proposal would toughen standards for drugmakers looking to sell new opioids, and it’s one of several measures the US drug regulator is considering to tackle one of the most pressing public health challenges. from the country.

However, the FDA cannot act alone. Congress should give the FDA the power to impose such a requirement.

“Currently, the FDA does not have the legal authority when dealing with a new drug application to require it to offer superiority over drugs that are already on the market. The legal comparative standard is compared to placebo or nothing,” Califf said.

A National Academies report released in 2017, which Califf requested during his first tour as commissioner, pointed to this limitation in the FDA’s ability to assess new drug applications.

“Showing that a drug has substantial evidence of efficacy does not necessarily mean that the drug is more effective than currently available therapies, or that the demonstrated efficacy is clinically significant,” the report states.

Opioid overdoses have killed nearly half a million Americans in two decades. Opioid-related deaths continue to rise, according to data from the Centers for Disease Control and Prevention.

Good direction

The proposal is one of many areas where the FDA “will likely come back to you if there is agreement within [the Department of Health and Human Services] and say we need new legal authorities,” Califf told lawmakers.

But Tildabeth Doscher, an addiction medicine physician at the University at Buffalo, said measures to stem the drug overdose epidemic must stop focusing on opioid production.

“We need more restrictions, more education, more restrictions on opioid prescribing itself,” Doscher said in an interview. “It’s a nod in the right direction, but I think it’s a lot of energy invested in places where energy could be spent more efficiently.”

Doscher said she supports the development of painkillers that do not work on opioid receptors, so there is no risk of long-term physical, physiological and psychological addiction. With one in five Americans living with chronic pain, she said she would like to see a focus on treating pain through non-pharmacological means.

“I would like to see a lot of effort put into that. And if in fact we use pharmacological methods, focusing on things that people don’t develop a tolerance or addiction to.

Asked by Sen. mike brown (R-Ind.) When the FDA may issue regulations based on the recommendations of the National Academies report, Califf said, “Within the next year or so soon.”

“There’s a whole bunch of stuff, some of which is happening right now, and some of which you’ll see next month,” Califf said.

The FDA has already released draft guidance based on the report’s recommendations, which outlines the risk-benefit framework the agency uses to decide whether to approve an opioid.

“Normally, the way a decision on the risk/benefit balance of a drug works is that it is a risk and a benefit for the person for whom the product is prescribed. But that’s not enough for opioids,” he said, due to the widespread misuse and abuse of these drugs.

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