The Food and Drug Administration (FDA) is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents.
The review comes as regulators disclosed the number of doctors who completed voluntary training program is less than is less than half that targeted by the agency. Under the current risk-management programs, drug makers fund voluntary training for physicians on how to safely prescribe their medications. However, many experts, including a previous panel of FDA advisers, said those measures don’t go far enough and that physician training should be mandatory.
Only 37,500 physicians completed the voluntary training, less than half of the targeted number of 80,000.
The FDA’s initial ideas to improve safety included mandatory certification for doctors and a national registry to track patients taking the drugs. But industry pushed back. Drug makers and the pain specialty groups they fund argued that certification would be too burdensome for doctors, leaving many patients under-treated. And patient groups said that registries would unfairly stigmatize those who rely on painkillers to deal with long-term pain.
The FDA’s final plan were ultimately much milder than its initial proposals. Patients would receive pharmacy pamphlets about the risks of opioids and drug makers would fund optional physician training.