The FDA should have revised flawing programs years ago, report finds.
The Food and Drug Administration (FDA) “failed to use its authority to make sure a program to curb improper prescribing of opioids was effective,” according to researchers at the Johns Hopkins Bloomberg School of Public Health who argue the agency should have done more to stop the crisis. This occurred even as an increasingly prevalent epidemic was killing tens of thousands of individuals who were dying of overdoses. In 2011, the agency began asking Purdue, the makers of OxyContin and other addictive long-acting opioids, to pay for safety training for physicians and to document the effectiveness of this training in reducing addiction and fatalities. Yet, the FDA was never able to determine whether the program worked, researchers note, because of data collection flaws. What’s more, when the collection methods were questioned, the agency never asked for improvements to the program, called a “risk evaluation and mitigation strategy or R.E.M.S.” The recent research was published in JAMA Internal Medicine.
“What’s surprising here is the design of the program was deficient from the start,” said Caleb Alexander, the senior author of the study, who believes action steps to stop the crisis could have been taken. “It’s unclear why the FDA didn’t insist upon a more scientifically rigorous evaluation of this safety program.”
Dr. Andrew Kolodny, the co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis, called the program “a really good example of the way FDA has failed to regulate opioid manufacturers. If the FDA. had really been doing its job properly, I don’t believe we’d have an opioid crisis today.”
The main goals of the 2011 program were to train more than half of 320,000 medical personnel prescribing the drugs to do so safely and to inform patients of the risks. However, the Hopkins’ researchers who gathered pages of internal FDA documents discovered the agency repeatedly could not determine whether the strategies were, in fact, working, because of the flawed design. And, the agency did not take the steps to put into place a more effective program.
In 2019, the same Hopkins researchers found failings in a similar safety program the FDA established in 2011 to put a stop to inappropriate use of a certain class of fast-acting fentanyl drugs meant only for cancer patients. Doctors were told they had to undergo training related to the risks of prescribing fentanyl for non-cancer patients. Yet, many continued to prescribe it to these patients, anyway, because doing so was profitable, and the agency did little else to intervene.
Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health, and one of the paper’s authors, said it was “extraordinarily important for the FDA to not only ensure safe prescribing programs are effective, but to keep the public informed if they are not.” Sharfstein was the principal deputy commissioner of the FDA from March 2009 to January 2011 and said that while he “was not deeply involved in developing the safety. program for long-acting opioids, I wish I had focused on it more.”
In a statement, Jeremy Kahn, a spokesperson for the FDA, said that the agency programs have been rolled out to stop the crisis. He stated, however, “We understand and acknowledge that there is still much work to do to bring down opioid abuse.”