According to a study recently published in JAMA Internal Medicine, the Food and Drug Administration (FDA) did not verify whether a program designed to control the opioid crisis actually worked, mostly due to poor oversight on behalf of the agency.
The study, conducted by researchers at Johns Hopkins Bloomberg School of Public Health, involved a search of thousands of FDA documents released in response to a Freedom of Information Act (FOIA) request. The study found that the FDA was unable to determine if the program to train more than 160,000 doctors on reducing their prescribing of opioids actually did any good.
The FDA program started in 2011 when the FDA asked Purdue Pharma (the manufacturer of OxyContin) and other opioid manufacturers to pay for safety training for over half of the physicians prescribing opioids and to track the effectiveness of the training and other measures in how well they work to reduce addiction, overdoses, and death.
The main purpose of the program was to train more than half of the roughly 320,000 doctors who prescribed the drugs on how to prescribe them safely, and also to inform patients about the significant risks of taking the drugs.
“What’s surprising here is the design of the program was deficient from the start,” according to the study’s senior author, Caleb Alexander. “It’s unclear why the FDA didn’t insist upon a more scientifically rigorous evaluation of this safety program.”
It unfortunately isn’t just the study’s authors who were also disappointed in the FDA’s management of the program. Dr. Andrew Kolodny, the co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis, said the safety program was a missed opportunity. Dr. Kolodny referred to the program as “a really good example of the way F.D.A. has failed to regulate opioid manufacturers. If F.D.A. had really been doing its job properly, I don’t believe we’d have an opioid crisis today.”
By way of reminder, the FDA program stemmed from legislation in 2007, whereby Congress gave authority to the agency to train physicians to safely prescribe certain drugs in response to agency lapses in oversight of “dangerous drugs” like Vioxx, a painkiller that was taken off the market in 2004 after it was found to pose a substantial heart risk.
This Isn’t the First Indication the Program Doesn’t Work
This is not the first sign that the program is faulty. In 2010, an FDA advisory committee of pain management experts voted 25-10 against the proposed program design. At that time, committee members suggested that the FDA require training for prescribers, and that it redesign curriculums to lessen industry influence. The FDA ignored the suggestions and moved forward with its plan.
Then, a 2013 report by the inspector general of the Department of Health and Human Services found that only 14% of the safety programs reviewed by the FDA reached their goals. In 2018, another inspector general report found that the agency did not have the authority to take enforcement actions against companies that did not provide it with enough information to assess their safety programs — a common problem.
Also in 2018, the same Hopkins researchers that conducted this study found failings in a similar safety program established by the FDA in 2011 to stop inappropriate use of a small class of fentanyl drugs meant for cancer patients. The program required doctors who prescribed those drugs to take classes and sign forms saying they understood the dangers of prescribing the drugs to patients without cancer, but many continued to prescribe the drugs to patients other than those diagnosed with cancer.
FDA Response
In a statement, Jeremy Kahn, a spokesman for the Food and Drug Administration, disputed the authors’ contention that the agency had abandoned efforts to evaluate the success of its program, pointing to a number of steps it had taken in the last three years to study the effects of education on prescribing patterns.
“We understand and acknowledge that there is still much work to do to bring down opioid abuse,” Mr. Kahn said in the statement.