When deciding how to regulate opioid painkillers, regulators at the Food and Drug Administration should study how the medicine will affect patients' families, American society, and the black market for drugs, according to a major new report. Published at the behest of the Obama administration's FDA head, the report recommends the agency look beyond its usual considerations: the risks and benefits of a drug and how it compares to treatments that are already FDA-approved.
"This is in distinction to the traditional approach that the FDA takes when it evaluates products," Aaron Kesselheim, one of the report's authors and a lawyer and doctor who studies countries' drug approval processes at Harvard Medical School, said during a public conference call about the report. "But the particular characteristics of opioids, we believe, requires a certain amount of what we term 'opioid exceptionalism' from the regulator."
Once the FDA has this radical, recommended new method for considering opioids in place, Kesselheim and his team think the agency should additionally re-review every opioid painkiller already on the market, sometime "over the next few years."
The FDA commissioned Kesselheim's panel last year to come up with advice for what it should do about the opioid epidemic in America. In 2015, 33,000 Americans died with opioids, including prescription painkillers and heroin, in their systems. Because some people report their addictions started with legitimate prescriptions, and because overdoses rose in America alongside skyrocketing prescription rates in the 1990s and 2000s, many experts think regulating drug companies and prescribing is an important part of stemming the tide.
Now, the panel's recommendations are in, and they're asking for significant changes to the FDA's current system. Still, the recommended changes are not unprecedented, Kesselheim and his colleagues argue in their report. The laws that govern the FDA give the agency authority to consider drugs' effects on public health and society, and the agency has done so before, with testosterone gel, antibiotics, and fentanyl patches, the report argues.
Other exceptional measures the panel recommends include requiring drug companies to follow stricter rules when advertising opioids than they would for other types of medicines, and creating campaigns to teach doctors and the public about the best ways to manage chronic pain. During the call, Kesselheim said such campaigns shouldn't be run by drug companies, although, traditionally, drug companies sponsor many continuing education programs for doctors.
"Overzealous promotion and financial relationships between the pharmaceutical manufacturers of opioids and physicians through the '80s and '90s and 2000s, I think, at this point, has been shown to be a contributor to overprescribing in this area," he says.
Overall, the report reflects the belief among many experts that opioid painkillers are often too risky to use to treat chronic pain. (Giving people opioids to help them with pain after surgery, or because of cancers or terminal illnesses, is less controversial.)
The FDA commissioner who asked for the new report, Robert Califf, stepped down in January as a part of the White House administration transition. The new FDA commissioner, Scott Gottlieb, released a supportive statement about the report and touted the efforts the agency is already undertaking.
"We greatly appreciate all the work done by NASEM [The National Academies of Sciences, Engineering, and Medicine] over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue," the statement says. "I was encouraged to see that many of NASEM's recommendations for the FDA are in areas where we've already made new commitments."