Gottlieb: FDA seeking 'right balance' in regulating opioid prescriptions
FDA Commissioner Scott Gottlieb reaffirmed in a statement Monday the agency’s commitment to finding the “right balance” between reducing the U.S. rate of opioid addiction and providing access to legitimate patients, for whom these medications can be lifesaving.
He had strong words for practitioners regarding their role in helping spur the opioid epidemic. "The roots of this crisis are embedded in the practice of medicine, and prescribing practices that were at times too cavalier," Gottlieb said.
The agency touched on their opioid addiction-fighting greatest hits without introducing a concrete plan for action, although Gottlieb called for a “number of new steps” to combat a national crisis the director of the CDC is calling “more deadly than the AIDS epidemic.”
Beyond good medical management, the FDA recognized it too has a part to play in ameliorating the opioid crisis, citing its revised blueprint for drug manufacturer training to be finalized later this year and its innovation challenge to foster development of novel, pain-treating medical devices. At the same time, payers like Aetna, Anthem and Cigna are making their own efforts to combat overprescribing.
Gottlieb also said the FDA will work to encourage medical professional societies to develop evidence-based guidelines on correct opioid prescribing practices to reduce careless or superfluous dispensing. “Unfortunately,” Gottlieb writes, “the fact remains that there are still too many prescriptions being written for opioids.”
However, overprescribing is just one element of the challenge. Opioid prescribing is dropping, at least according to one survey.
The American Medical Association’s Opioid Task Force 2018 Progress Report found that American physicians are prescribing fewer opioids and more naloxone, a medication used to block the effects of opioids, as well as increasing prescription drug monitoring program use.
Opioid prescription, AMA reported, decreased by 22% between 2013 and 2017, and PDMP use increased 121% between 2016 and 2017 alone.
AMA called for policymakers and regulators to increase oversight, which the FDA is clearly on board with.
However, although opioid prescriptions have dropped, addiction and overdose have continued to rise due to the prevalence of and easy access to illegal, cheap opioids such as heroin or illicitly made fentanyl, heroin’s synthetic, and much more potent, analog.
And despite limited progress, costs in dollars and deaths are still rising.
Opioid addiction and overdose treatment costs in large employer-based health plans increased by a factor of nine between 2004 and 2016, even though opioid prescriptions have steadily fallen since their peak in 2009.
The rate of drug overdose deaths involving synthetic opioids such as fentanyl doubled between 2015 and 2016. In 2016 alone, there were more than 63,600 drug overdose deaths in the U.S.
Experts agree that a multifaceted and comprehensive approach is needed to slow the cresting opioid epidemic. Bipartisan legislation is currently being workshopped in Congress, with measures ranging from restructuring grants to help states boost addiction treatment in hard-hit areas to removing barriers to non-addictive medication research.
It’s a “difficult challenge both for the FDA and for providers,” Gottlieb admitted in the statement. “We don’t want to act in ways that are poorly targeted."