Independent Review Recommends Congress Give New Opioid Authority to FDA
In August 2022, the Commissioner of Food and Drugs Robert
Califf, M.D., commissioned an independent review of the Food and Drug Administration’s
(FDA’s) programs responsible for improving oversight of opioids and helping
to combat misuse. The Ohio State University, who conducted the
independent review,
recently released its findings. One of its major recommendations was that the FDA should
seek “from Congress certain additional authorities regarding opioid analgesic
approvals and its review of the advertising and promotion for such products, as
well as additional resources to implement such authorities.” Lack of resources,
especially human capital, has hampered the FDA’s efforts for years.
The review specifically noted that if additional authorities
were granted, the FDA would have the authority to require new opioid products
show a benefit over painkillers already available. New opioid products would be
required to show a “comparative advantage” over existing treatments.
Currently, the FDA does not have legal authority to do this.
Commenting on using “comparative advantage” as a basis
for new opioid approval, Califf stated that comparative advantage has the “. . . potential
to, over time, improve the safety of opioid analgesics available to treat severe
acute and chronic pain or drive research towards non-opioid alternatives to relieve pain.”
