How the FDA Helped Fuel the Opioid Epidemic

WALL STRET JOURNAL: OPINION –

May 2, 2023 – At an April Senate subcommittee hearing, Food and Drug Administration Commissioner Robert Califf blamed the pharmaceutical industry for a lack of nonaddictive nonopioid pain medications. In his telling, the FDA is waiting with open arms for any new analgesics that industry may develop: “We need to do everything we can do to push industry and make this happen.”

He’s partially right: The government should commit itself to supporting private innovation. But it is disingenuous to blame industry for a dearth of treatments. Consider the evolution of the drug Toradol—generic name ketorolac—a case study in the agency’s propensity to scuttle effective medicine.

Several decades ago the pharmaceutical company Syntex, where I once worked, discovered and developed injectable ketorolac: a nonsteroidal anti-inflammatory drug, or NSAID, used to provide morphine levels of pain relief without the same abuse potential as opioids. The FDA approved the drug in 1989, and it soon hit the market under the brand name Toradol IV/IM, joining other popular though less potent NSAIDs such as Advil, Motrin, and aspirin.

Before approval, an FDA employee suggested that Toradol IV/IM be given with a loading dose—that is, twice the standard amount. Against their better judgment, Syntex employees complied.