When the U.S. Food and Drug Administration screens new opioid drugs it should better anticipate how people might abuse them in the real world, the National Academies of Sciences, Engineering and Medicine warns in a major report issued Thursday on the country’s opioid crisis, which kills 91 people a day—often via overdoses on prescription drugs. The FDA needs to move beyond its traditional focus on clinical studies about drug effectiveness and side effects, and to seek public health data on potential abuse, the Academies advises in its 400-page proposal for targeting the deadly issue.
The FDA had asked for the report, and its release comes as several states are suing pharmaceutical companies over allegations that they downplayed the addictive nature of certain prescription painkillers and helped fuel the current crisis. “The focus of the request from the FDA was for advice on what they could do to evaluate [opioids] more completely before approving them for use,” says Stanford University anesthesiology professor David Clark, a member of the Academies committee that drafted the report. A key recommendation, Clark says, is for “the FDA to move beyond its standard matrix of considerations for drug safety and—at least for opioids—move into a more public health–centered matrix of considerations which could help us predict what might happen for people beyond the intended recipient of the drug.”
The 18-member committee, which worked on the report for more than a year, identified specific steps that states, federal agencies and medical providers should take to stem the tide of abuse of substances including heroin, fentanyl and prescription drugs—even as they ensure pain patients have access to legal relief. Any policy that aims to restrict lawful access to prescription opioids would drive some people toward the illegal market, the report warns. Instead it urges states, regulators and public health agencies to work toward universal access to evidence-based interventions for substance abuse, including treatment programs and full coverage of medications approved to fight addiction. The report calls for expanding access to the overdose antidote naloxone to laypeople, and also says jurisdictions should explicitly authorize syringe exchange as well as their sale or distribution. “Reducing the scope of the epidemic of opioid addiction is my highest immediate priority as commissioner,” the FDA’s Scott Gottlieb said in an e-mailed statement. “I was encouraged to see that many of [the Academies’] recommendations for the FDA are in areas where we’ve made new commitments.”
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The Academies’ report also recommends increasing the FDA’s formal reevaluations of opioid approval decisions, in order to ensure that the drugs’ benefits still outweigh the risks. It advises the FDA and other federal health agencies to improve their data tracking on pain and opioid use, and to invest more money in research for a clearer picture of the opioid epidemic—and for potential ways to combat it, such as programs that track prescribing and dispensing information.
Officials battling the crisis on the ground applauded some of the Academies’ findings. “The report is in line with the work we are already doing in Baltimore City,” says Leana Wen, the city’s public health commissioner. “We have had needle exchange programs for over 20 years, and we also have a very aggressive naloxone program.” The report focuses on improving research and regulatory actions before a prescription drug hits the market, Wen notes. “All these are important, but I continue to emphasize what I see on the frontlines—a need for increased access to treatment that is evidence-based and well established.” With naloxone’s price rising and a shortage of substance abuse treatment beds, these are crucial needs, she says.
The report also says states should take specific actions, such as creating more year-round programs in which pharmacies or other establishments take back unused prescription painkillers—so they do not sit around patients’ houses, where they might be abused or stolen. (According to the National Institute on Drug Abuse, nearly half of young people who inject heroin abused prescription opioids first.) “The concerns on this point are more impetus rather than obstacle,” Clark says. “It is not uncommon to have drug take-back programs through churches, pharmacies, universities, and public interest groups and community organizations. But none of those organizations are set up to do that kind of thing on an ongoing basis.” Some pharmacies have already moved in this direction by setting up drop boxes to dispose of old drugs when someone comes in to fill a new prescription, he adds.
The President’s Commission on Combating Drug Addiction and the Opioid Crisis, chaired by New Jersey Gov. Chris Christie, also aims to come up with concrete recommendations. It was scheduled to release an interim report last month but has not done so, and now expects to put the report out at the end of this month, around its next meeting. “The Commission is continuing to look at how the administration can best address this unprecedented crisis and will be releasing its [final] report in October,” Richard Baum, acting director of the Office of National Drug Control Policy, told Scientific American in an e-mailed statement. “The Trump administration is committed to addressing the opioid epidemic,” Baum wrote, and in just six months it has “sent nearly $500 million to the states to address the epidemic locally, begun work on the president’s first National Drug Control Strategy and established the President’s Commission on Combating Drug Addiction and the Opioid Crisis.” (The latest version of the Senate health care bill, released Thursday, also would include $45 billion to help support substance abuse treatment.)
Addressing the opioid epidemic requires action in the medical and patient community as well, the Academies’ committee says. It advises states to create better pain education materials for medical schools, medical licensing boards and the public. States and the federal government should also work in concert to help boost access to medication for addiction—and to make sure patients can afford it, the report says. Managing the opioid crisis is a balancing act requiring trade-offs when it comes to restricting the lawful opioid supply, influencing prescriber practices, cutting demand and reducing harm, the committee members wrote. Yet they add that their proposal should, “leave adequate space for responsible prescribing and reasonable access for patients and physicians who believe an opioid is medically necessary.”