Addiction experts question FDA's suggestion to cap opioid prescriptions
FDA Commissioner Scott Gottlieb's proposal to limit painkiller prescriptions from doctors has raised alarm bells for addiction experts, who say the move will undermine doctors' medical judgment.
During an appearance in front of the House Appropriations Committee Thursday, Gottlieb suggested that limiting prescriptions for painkillers could be a key tool to battling the opioid addiction crisis gripping the nation.
"What we need to do as a matter of public health is make sure patents are only getting exposed to opioids in appropriate clinical circumstances and only for the appropriate duration needed," Gottlieb told lawmakers. "So no more 30-day prescriptions for a tooth extraction."
The comments come two days after the Food and Drug Administration posted an announcement that Gottlieb directed his staff to explore "more forceful" efforts to curb the epidemic, including limiting prescriptions or requiring physician training on proper use of the painkillers as part of a treatment plan.
But addiction experts say limiting prescriptions usurps physicians' judgment on how to treat their patients.
"I would be concerned about FDA or any other federal agency dictating medical treatment," said John Gilbert Jr., an attorney focusing on controlled substances and prescription drugs issues at Hyman, Phelps & McNamara. "A physician is required to make a medical decision on the appropriate care for patients and in the case of pain treatment, one size does not fit all."
As many as 50 million American adults have significant chronic pain or severe pain, according to the National Institutes of Health. Continued opioid access is critical for many of them to have adequate quality of life, according to Richard Epstein, a New York University law professor who teaches courses on FDA regulation. "It's kind a constant trade-off between greater and lesser evil."
The FDA doesn't have the statutory ability to limit the amount of pills or the duration of prescriptions. However, the agency could deem prescriptions off-label if they're too large. That would give insurance companies an incentive to not pay for large prescriptions and discourage physicians from writing them, according to Dr. Nathaniel Katz, a neurologist and pain specialist.
"Doctors should have the last word, if they have adequate training," said Katz, founder and president of Analgesic Solutions, a clinical trial consulting firm.
Some of the FDA's suggestions could gain backing from addiction advocates. Katz said he supported the FDA's exploration to enhance physician's opioid training.
"Doctors have no idea how much to prescribe so they prescribe enough that they don't get a call back," Katz said.
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