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FDA Opens Review Into Opioid Prescribing, Warning Regulations (2)

Aug. 30, 2022, 2:26 PMUpdated: Aug. 30, 2022, 9:13 PM

The FDA has opened an extensive review of opioid regulations and is launching a framework aimed at preventing overdose-related deaths nationwide, the agency’s head announced Tuesday.

Food and Drug Administration Commissioner Robert M. Califf said in a blog post that the agency has initiated a review into past opioid decisions, including labeling, “with the intended goal of understanding what revisions are needed to support appropriate use of opioid analgesics.”

Califf first committed to leading a review on opioid regulations during his December 2021 confirmation hearing, following repeated questions from lawmakers on the FDA’s response to the opioid epidemic. Lawmakers have long criticized the FDA’s approval of Purdue’s OxyContin and other addictive drugs without requiring more thorough warning labels and other protections that could help combat misuse.

“The goal is not looking back to cast blame,” Califf said in an interview Tuesday. “It’s looking back to understand the basis for the decisions and ask the question of, ‘Knowing what we know now, should we think about things differently?”

The FDA’s framework for overdose prevention includes four main areas: eliminating unnecessary initial prescription drug exposure and inappropriate prescribing of opioids, encouraging harm reduction, boosting the development of treatments for substance-use disorders, and protecting the public from counterfeit drugs that contain elevated overdose risks.

The framework follows the release of the Department of Health and Human Services’ Overdose Prevention Strategy and President Joe Biden’s National Drug Control Strategy. Biden in April called on federal agencies to prioritize addiction treatment, crack down on international and domestic drug trafficking and production, and boost efforts to stop children and young adults from using addictive opioid products.

Califf told Bloomberg Law that the FDA plans to announce additional information soon on an external group who will help conduct the agency’s review. Califf said the review will likely take a “matter of months” to complete.

Looking Back

Nearly 92,000 drug overdose deaths occurred in the US in 2020, 30% higher than the previous year, according to a July report from the Centers for Disease Control and Prevention.

Black people saw the highest increase in overdose fatalities, going up 44% between 2019 and 2020, with overdoses deaths among American Indians and Alaska Natives increasing 39% in the same time period. These both outpaced the 24% increase in fatalities among White people.

Califf told reporters in a July 28 press briefing that there’s “no magic bullet” to address the opioid crisis, and that responses will be “incremental” and multi-pronged.

In his December confirmation hearing, Califf said the FDA’s approval of oxycontin in 1995 “with no long-term studies and no assessment of the addictive capabilities is something that could have been done differently.”

Califf told Bloomberg Law Tuesday that his view remains the same. He added that the FDA’s assessment of previous opioid approvals will address the lack of existing “high-quality evidence about long-term opioid use.”

“There are a lot of people that are on chronic opioid therapy now, and one of the lessons of the last five years is that you can’t just stop people immediately,” he said. “We also need to make decisions based on the evidence we currently have about labels.”

Lawmakers have repeatedly railed against the FDA over concerns that labels for OxyContin and other opioids made it easier to prescribe the drug for long-term use and didn’t adequately include safety warnings on the potential for misuse.

Overdose Prevention

The overdose prevention framework highlights a combination of existing activities and additional work to address multiple facets of the opioid epidemic, including illicit drug trading and prescriber education.

The FDA has previously implemented plans to combat the opioid epidemic. Former Commissioner Scott Gottlieb’s 2018 Opioids Action Plan included working more closely with advisory committees before making certain product and labeling decisions.

Califf said the framework introduced Tuesday builds on previous FDA actions, but also aims to combat issues “much more pronounced now than before,” including the sale of illicit synthetic fentanyl and methamphetamines.

To combat this, the new framework includes plans to improve the FDA’s surveillance of counterfeit and potentially dangerous products found at international mail facilities and US ports of entry.

The FDA’s primary prevention actions include reexamining prescriber education on the potential for opioid misuse. The agency will look at the “need for a mandatory unified, national-level education program to adequately inform opioid analgesic prescribers on managing pain,” according to Califf’s blog post.

Califf wrote that the agency’s opioid response may also require new FDA authorities to implement additional standards in the review of opioid applications, including that drug developers demonstrate their products “offer material safety advantages over” already-approved opioids.

“In general, the FDA does not have authority to require comparative effectiveness of medical products,” Califf told Bloomberg Law, adding that it will take “convincing Congress” to modify existing law or introduce new legislation granting the FDA this power.

Califf said that while “there’s not a flood of new opioid companies applying for FDA approval,” it would be beneficial “to find a way to get products on the market that actually really do have a demonstrated material advantage” and have a “benefit that exceeds the risk.”

Addressing Disparities

Califf said there’s “not that much the FDA can do directly” in addressing racial and ethnic disparities in overdose fatality rates, but that “there’s a lot that we can do by collaborating with the other agencies and making sure that our policies are not inadvertently making the problem worse.”

One way to do this is by working with the Centers for Medicare & Medicaid Services and the Substance Abuse and Mental Health Services Administration to get naloxone distributed much more broadly to low-income and minority communities, he said.

“Most of what we want to do involves close collaboration with some other entity or often more than one entity,” Califf said. “There are literally many things that need to be done, each of which is incremental, but if we could do more of them more quickly, it could have a significant effect.”

(Updated with comments from interview with Califf.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com