The Food and Drug Administration (FDA) did not ensure that a program designed to reduce improper opioid prescribing was effective, according to a report published this week.
In 2011, the FDA began asking opioid makers to pay for safety training for more than half of doctors who prescribed opioids. The agency also asked the drug companies to track how effective the training was, and to evaluate other measures in reducing addiction, overdoses and deaths, The New York Times reports.
The manufacturers did not gather the correct type of data, so the FDA was not able to determine whether the program worked, researchers reported in JAMA Internal Medicine. Even when the FDA found through its own review process that the data gathering was flawed, it never demanded improvements to the program, the researchers found.
“What’s surprising here is the design of the program was deficient from the start,” said senior study author Caleb Alexander of the Johns Hopkins Bloomberg School of Public Health. “It’s unclear why the F.D.A. didn’t insist upon a more scientifically rigorous evaluation of this safety program.”