Gottlieb: FDA seeks "good balance" in regulation of opioid prescriptions

Dive Brief:

• Scott Gottlieb, chief of the Food and Drug Administration, reiterated in a statement Monday the agency's commitment to striking the right balance between reducing the dependency rate on opioids in the United States and access to legitimate patients.
• He had strong words for practitioners regarding their role in stimulating the epidemic of opioids. "The roots of this crisis are rooted in the practice of medicine and prescribe practices that are sometimes too cavalier," Gottlieb said.
• The agency has tackled its initiatives to combat opioid addiction without introducing a concrete plan for new actions. Although Gottlieb has called for a "number of new measures" to fight a national crisis, the director of Centers for Disease Control and Prevention calls it "more lethal than the AIDS epidemic".

Dive Insight:

he also has a role to play in the fight against the opioid crisis, citing his revised drug manufacturing training project to be finalized later this year and its challenge of innovation to promote the development of new medical devices treating pain. At the same time, payers like Aetna, Anthem and Cigna are making their own efforts to combat over-prescription.

Gottlieb also said that the FDA will encourage medical professional companies to develop evidence-based guidelines on good opioid prescribing practices. or an unnecessary distribution. "Unfortunately," writes Gottlieb, "the fact remains that there are still too many prescriptions for opioids."

However, over-prescription is only one element of the challenge. The prescription of opioids is down, at least according to one survey.

The Opioid Task Force 2018 progress report from the American Medical Association found that American doctors prescribe fewer opioids and more naloxone, a drug used to block opioids, as well that

The prescription of opioids, AMA, decreased by 22% between 2013 and 2017, and the use of PDMP increased by 121% between 2016 and 2017.

AMA called policy makers and regulators to strengthen surveillance, However, although opioid prescriptions have declined, addiction and overdose have continued to increase due to the prevalence and easy access to illegal and cheap opioids such as heroin or illicitly made fentanyl, synthetic heroin. , and much more powerful, badog.

And despite limited progress, dollar costs and deaths continue to increase.

Opioid Addiction and Overdose Treatment Between 2004 and 2016, the costs of large employer health plans increased nine-fold, even though opioid prescriptions fell from their peak in 2009.

Overdose death rate of synthetic opioids such as fentanyl doubled between 2015 and 2016. In 2016 alone, there were more than 63,600 drug overdose deaths in the United States

Experts agree that & ## A multidimensional and comprehensive approach is needed to slow down the current epidemic of opioids. Bipartisan legislation is currently being drafted in Congress, with measures ranging from restructuring grants to help states boost drug treatment in hard-hit areas to spur research for non-addictive drugs

. "Gottlieb recognized in the statement." We do not want to act in a poorly targeted way. "