WASHINGTON– A long-awaited review of prescription opioid drugs, including their risks and contribution to the overdose epidemic in the United States, is still underway at the Food and Drug Administration, the agency’s commissioner said Tuesday.
Dr. Robert Califf wrote in a blog entry that the FDA is still considering “what revisions are needed to support the appropriate use” of opioid painkillers and “lessons learned” by the agency. The update is part of a larger overview of FDA ideas and initiatives to combat drug abuse and addiction.
Califf told The Associated Press that the scale of the outbreak makes potential cures a challenge.
“Almost everything we want to do involves some other entity or part of society that we have to work with to figure things out,” Califf said in an interview Tuesday.
Califf has promised to conduct a comprehensive review of the FDA’s approach to opioids, including their prescribing guidelines, to seek Senate confirmation early this year. He told the AP last month that the public would soon hear “a lot more about it.”
Part of the delay in drug re-evaluation is that the makers of long-acting opioids didn’t originally study the drugs’ effectiveness for long-term pain, which carries risks of addiction and overdose. Studies commissioned by the FDA to answer this question have been dragging on for years.
“The FDA does its best when it has high-quality evidence, and we don’t have high-quality evidence right now,” Califf said, adding that government-led studies may ultimately be needed. to answer the question of the long-term safety and effectiveness of opioids.
Tuesday’s update is also unlikely to appease Califf’s critics in Congress, including five Senate Democrats who voted against his nomination, largely over fears the FDA hasn’t taken bolder action. to reduce opioid prescribing and abuse.
This isn’t the first attempt at an opioid reset for the FDA — or even for Califf. During his brief stint as FDA commissioner at the end of the Obama administration, Califf also pledged to conduct a “thorough review” of opioids.
Dr. Andrew Kolodny, an FDA critic who has testified against the drugmakers in court, said Califf needs to do more than revisit the FDA’s “lessons learned” on opioids.
“He also has to shoulder the heavier burden of correcting past mistakes” by taking unproven drugs off the market, said Kolodny, who leads a group that promotes stricter opioid prescribing.
Last year, overdose deaths in the United States hit a record 107,000, overwhelmingly caused by fentanyl and other illegal opioids. Opioid prescriptions have dropped by about 40% over the past decade, but drug-related deaths remain at 13,000 to 14,000 per year.
Califf’s post lays out a framework for addressing drug addiction and overdose in general, focusing on reducing inappropriate prescribing, developing new addiction and overdose therapies, and shutting down illicit drug suppliers.
But many of the agency’s specific ideas failed to gain traction.
For example, a recent FDA proposal that would require pharmacies to distribute “mail-back” envelopes with every opioid prescription has met with resistance from pharmacists, drugmakers and other groups. Elsewhere, the FDA has tried for nearly a decade to require doctors and other healthcare professionals to undergo training in the safe prescribing of opioids. That effort has been stymied by the question of whether it requires action by Congress or other government agencies. Medical societies generally oppose any blanket requirement.
Califf said the FDA continues to work with other federal officials to find a way to implement broader training.
“I’m personally in favor of compulsory education,” Califf said, but it has to fit “clinicians’ needs, which I think is very difficult to do.”
Califf said another priority would be encouraging the development of an over-the-counter version of naloxone, the drug that can reverse an opioid overdose. Most states have passed measures allowing pharmacists to dispense the drug without a prescription, but an over-the-counter version would further expand access.
Even this proposal could have unintended consequences if consumers are unable to purchase naloxone that is no longer covered by insurance.
“We know more naloxone is needed,” Califf said. “The question is how to do that.”
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.