FDA’s Approval Process of Opioids Faulted
Clinical trials were too short, patient groups too narrow and safety was rarely assessed, says a new study of the agency's opioid approval process.
Stat:
For Two Decades, The FDA Approval Process For Opioids Had Numerous Shortcomings, Study Finds
Over more than two decades, the Food and Drug Administration approved opioid painkillers based on relatively brief pivotal clinical trials that relied on narrowly defined patient groups and rarely assessed key safety outcomes, according to a new study. Specifically, the study found that, for opioids approved between 1997 and 2018 as treatments for chronic pain, none of the trials lasted longer than three months. Moreover, the trials often excluded patients who could not tolerate the painkillers and generally failed to systematically evaluate such known risks as tolerance, drug diversion and so-called non-medical uses. (Silverman, 9/29)
Becker's Hospital Review:
FDA Opioid Approvals Relied On Short Trials, Patient Exclusions, Study Contends
None of the clinical trials for opioids the FDA approved to treat chronic pain from 1997 to 2018 lasted longer than three months, according to research published Sept. 29 in Annals of Internal Medicine. Researchers discovered that only 21 of the 39 opioids approved by the FDA from 1997 to 2018 were supported by at least one pivotal trial. The median length of the trials conducted for opioids during this time was 84 days. (Adams, 9/29)
In other news on the opioid crisis —
The New York Times:
Coronavirus Pandemic Drives Hike In Opioid Deaths
On the first Friday in June, Jefrey Cameron, 29, left his home around midnight to buy heroin. He had been struggling with addiction for seven years but had seemingly turned a corner, holding down a job that he loved at Basil’s Pizzeria, driving his teenage sister to the mall to go shopping and sharing a home with his grandmother. But then the coronavirus pandemic hit. When he returned home that night and tried the product, it was so potent that he fell and hit his head in the bathroom. Mr. Cameron texted a friend soon after, saying that he had messed up and would go to a 12-step meeting with a friend that weekend. (Swift and Goodnough, 9/29)
Stat:
An FDA Safety Program Is Failing To Stem The Opioid Crisis, Report Finds
A mandated safety program regulators rely on to minimize opioid abuse and misuse is not “well suited” to quickly address the ongoing crisis across the U.S. And the shortcomings reflect a lack of cooperation from opioid makers that made it difficult for the Food and Drug Administration to assess key data, according to a new federal government report. At issue are REMS, or risk evaluation and mitigation strategy programs, which the FDA requires companies to develop when the agency approves a new medicine that may pose a safety risk. When the FDA decides a REMS program is necessary, drug makers must devise a program to provide physician and patient education, sometimes monitor distribution, and send the agency regular assessments. (Silverman, 9/29)
