The FDA and opioid manufacturers failed to independently determine whether physician safety training and patient medication guides mitigated improper opioid prescriptions and misuse, according to new federal records obtained by researchers through the Freedom of Information Act.
Why it matters: Federal regulators created this safety program in 2012 because opioid addictions, overdoses and deaths were rising, but researchers say the FDA's program relied on poor designs and data collection — and ultimately did nothing to prevent the opioid crisis from getting worse.
