New research found that the Food and Drug Administration couldn’t determine whether a program it had implemented to prevent doctors from inappropriately prescribing opioids worked. The program required certain opioid manufacturers to offer safety trainings for doctors who prescribed their products, as well as create medication guides outlining their risks. The study, published in JAMA Internal Medicine on December 30, found that the FDA failed to assess and enforce the program even as opioid overdoses claimed tens of thousands of lives per year, the New York Times reports.
“It’s unclear why the F.D.A. didn’t insist upon a more scientifically rigorous evaluation of this safety program," said Caleb Alexander, the senior author of the study, to the Times. Over the last decade, heroin — and later, fentanyl — replaced prescription painkillers as the primary reason for overdose deaths in the US, and the opioid prescribing rate has declined since 2012, but it still remains far above the national average in some counties, according to CNN.
Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis (who was not involved in the research) called the FDA’s program a failure to regulate opioid manufacturers. “If FDA had really been doing its job properly, I don’t believe we’d have an opioid crisis today,” he told the Times.
In the new study, researchers from Johns Hopkins Bloomberg School of Public Health analyzed nearly 10,000 pages of FDA documents on its Risk Evaluation and Mitigation Strategy (REMS) program, designed to ameliorate the risks of extended-release, long-acting opioids. This broad class of drugs includes OxyContin, fentanyl patches, and methadone (used for pain as well as opioid withdrawal), to name a few, the Times explains.
As part of its program, the FDA asked the manufacturers of such drugs to offer free safety training for doctors prescribing them, and assess how well these and other initiatives had curtailed adverse outcomes, including overdoses and deaths. The agency’s goal was for 60% of these doctors to undergo safety training between 2012 and 2016.
Yet the Johns Hopkins researchers found that only 27.6% of doctors had received the safety training during that time period, implying the FDA didn't come down on opioid manufacturers for not ensuring that their training reached as many doctors as possible. And even when the FDA’s own review revealed shortcomings in the REMS program, it didn’t push to address them.
Worse still, the agency couldn’t conclude whether the manufacturers’ safety strategies really did lead to safer prescribing by doctors or reduce adverse outcomes in patients, due to poor design of the analyses meant to assess them — which the manufacturers themselves had conducted, and the FDA had greenlit.
Their methodological issues made it impossible to conclude whether the safety strategies were directly responsible for the benefits the manufacturers had reported. Basically, we have no way to tell whether the FDA REMS program did what it was supposed to do: protect patients from improper opioid prescribing.
In response to CNN's request for comment, FDA cited other steps it’s taken against the opioid epidemic, such as supporting the development of less-addictive painkillers. Retired FDA senior executive William K. Hubbard called for the agency to exert more assertive control over not only opioid prescribing, but also manufacturing and distribution, in an editorial accompanying the review. For those whose lives have been touched by opioid addiction, the FDA could been more assertive much sooner.