Experts Respond to FDA’s Opioid Action Plan

The FDA announced a multi-pronged approach to ending the prescription opioid abuse epidemic last week. Experts in pain, addiction, and health policy Today their view of the intended reforms.

“As physicians we have treated both the intense suffering caused by acute pain and chronic pain… But we have also witnessed the devastating results of opioid misuse and abuse, such as the addiction of patients who have been prescribed opioids for pain treatment and increasingly, diversion to people for whom the prescription was not written,” wrote top FDA officials in a recent article for the New England Journal of Medicine detailing the agency’s newly developed plan.

The agency’s strategy includes several key elements:

• Reconsidering the risk-benefit paradigm for opioids to incorporate potential public health effects
• Convening an expert advisory committee to review any new opioid medication that lacks abuse-deterrent properties
• Meeting with the FDA’s Pediatric Advisory Committee to develop a framework for labeling pediatric opioids
• Incorporating new warning and safety information into immediate-release opioid labels
• Revising Risk Evaluations and Mitigation Strategy requirements for opioids per advisory committee recommendations
• Increasing the access to and development of abuse-deterrent opioids
• Expanding access to naloxone and medication-assisted treatment for patients with opioid use disorders
• Endorsing other non-opioid alternatives to treat pain

The proposal was announced in the wake of criticism of the nomination of Robert Califf, MD, as FDA commissioner, by several members of Congress. Sen. Bernie Sanders (I-Vt.) characterized Califf as too cozy with pharmaceutical companies. And Sen. Edward Markey (D-Mass.), is attempting to block the nomination in response to the FDA’s approval of oxycodone for use in children last year. He demands the decision be reversed.

MedPage Today asked clinicians and other health policy experts for their views of the FDA’s new plan.

John Renner, MD, a psychiatrist based in Boston and chair of the American Psychiatric Association Council on Addiction Psychiatry, based in Arlington, Va., said of the FDA’s new agenda, “I certainly think it will help.”

He added, “I think its naïve to think that the problem will simply disappear.” Renner said that even for those who legitimately need opioids and receive them appropriately, there is always a risk of abuse.

“The right intervention at this point is prevention,” he said. Physicians need to focus on screening patients to identify addiction histories and co-occurring psychiatric conditions.

“We don’t want people to have their meds withheld simply because they have a history of addiction, but we want to make sure that prescribing is done in a conservative and appropriate way.”

Joseph Lee, MD, medical director of the Hazelden Betty Ford Youth Continuum, based in Plymouth, Minn., said he’s thrilled that the whole country is talking about substance use disorder, but he recognizes that the issue is still very polarizing.

“Everybody is looking for a smoking gun instead of really trying to understand the complexity of a major societal crisis,” he said.

While the FDA has a responsibility to regulate drugs and help educate prescribers, he noted, “their jurisdiction is limited when it gets to what people are actually doing clinically.”

Viewing this initiative as a comprehensive plan is a mistake, he said, because there are so many different players.

For instance, prescription drug monitoring is regulated by the state, not any one federal agency.

Prescriber education is a problem shared by a number of agencies and organizations.

While, the FDA’s NEJM editorial touches on the issue, it doesn’t pose real solutions.

“How are we going to get physicians trained? What does that mean? Is that going to be mandated training? Are the medical organizations going to take responsibility?”

“There are a lot of different players that have to come to the table and all of them have a piece of the puzzle, and it will probably take all of their efforts and more.”

For some physicians, what FDA didn’t do was almost as important as what it did.

Steven Roskos, MD, of Michigan State University College of Human Medicine, told MedPage Today, “From what I can tell, they’re not going to make it more difficult to prescribe medicines that we think our patients need.”

Changes implemented in the past year, such as disallowing refills of hydrocodone, make more work for physicians without impacting practice. This means instead of writing out a prescription for a 3-month supply of a medicine, doctors must now write three separate 1-month prescriptions.

“It seems like a bad approach to make people be more thoughtful about their prescriptions,” he said.

And while this isn’t the FDA’s purview, Roskos added, “I think that medicine needs to police its ranks better, because there are physicians who are practicing unethically … and it’s very rare that a state medical board sanctions someone for doing things like that.”

Rosamond Rhodes, PhD, of the Icahn School of Medicine at Mount Sinai in New York City, said the FDA’s plan is off-target.

“It doesn’t strike me as something that will be especially effective,” she said.

However, she said her perspective, living in New York City, which already has careful oversight for prescription opioids, may differ from those in other states.

Rhodes said the most important barrier to fighting the opioid epidemic is access to mental health treatment. Health insurance plans don’t reimburse mental health treatment at the level of other medical treatments and that needs to change, she said.

Rhodes also spoke about the importance of researching non-opioid alternatives, including schedule 1 drugs.

While drugs with a schedule 1 classification are barred from federally-sponsored research, they may be less dangerous and more effective in treating pain, she said. The FDA has the authority to loosen scheduling, she said.

“Marijuana [a class 1 drug] doesn’t kill anybody… and it’s not very addictive, and it may be effective in alleviating pain that causes people to start taking opioids.”

Caroline Pearson, PhD, of Avalere Health, based here, said the FDA’s plan was a good “first step,” but “it entirely leaves out the payer side of the equation, which is a big deal.”

While several abuse deterrent opioid formulations are now available on the market, they have very low coverage in Medicare, she said, and are always going to cost “many times more” than a generic.

“The question is what do you do to encourage plans to cover these new drugs even though they’re going to be higher cost… Is that a benefit requirement or does the FDA start taking these older medications off the market?”

Even if the FDA were to remove all non-abuse-deterrent opioids from the market (which is not something Pearson recommends), people could still abuse opioids by simply taking more.

“There’s nothing on the market right now that addresses that issue.”