By Dennis Thompson
WEDNESDAY, Sept. 30, 2020 (HealthDay News) — For at least two decades, the U.S. Food and Drug Administration has been approving new formulations of prescription opioids without requiring drug manufacturers to gather important information on safety and effectiveness, a new study claims.
The FDA approved dozens of these highly addictive medications for treatment of chronic pain between 1997 and 2018 based on clinical trials that:
- Lasted no longer than 12 weeks,
- Failed to systematically gather data on adverse events or safety concerns,
- Actually weeded out of the final results from people who didn’t initially respond well to the drug.
“No trial was longer than 84 days, whereas people take these medicines for years and they’re labeled for chronic use,” said senior researcher Dr. G. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health in Baltimore.
The FDA continued to approve opioid drugs based on limited and flawed information even as the opioid epidemic swept across the United States, Alexander and his colleagues argue.
“The primary harms that have driven the opioid epidemic have been because of the oversupply of opioids, especially for chronic use,” Alexander said. “The FDA has missed important opportunities to require manufacturers to produce more meaningful and clinically useful information about the safety and effectiveness of these products.”
PhRMA, the leading trade group for pharmaceutical manufacturers, responded to the new study with a statement from Public Affairs Director Jasmine Gossett.
“The biopharmaceutical industry is committed to ensuring the safety and efficacy of prescription medicines,” Gossett said. “Industry aims to bring innovative medicines to the patients that need them, while also remaining focused on the U.S. Food and Drug Administration’s regulatory requirements regarding science-based safety and efficacy throughout the process.”
More than 46,000 people in the United States died of opioid overdoses in 2018, including nearly 15,000 who died from using prescription opioids, the researchers said in background notes. The number of drug overdose deaths in 2018 was four times higher than in 1999, according to the U.S. Centers for Disease Control and Prevention.
FDA kept approving new formulations of opioids as epidemic raged
In the study, Alexander’s team reviewed all 48 new drug applications for opioid medicines approved by the FDA between 1997 and 2018, the years during which the opioid epidemic overwhelmed the United States.
Of the 48 applications, only one was for an entirely new opioid — tapentadol, marketed by Janssen Pharmaceuticals under the brand name Nucynta. The rest were new dosages, new formulations or new combinations of existing opioids such as oxycodone, fentanyl, morphine, hydrocodone, oxymorphone and tramadol.
The clinical trials that gathered data for these applications never lasted longer than three months, even though the opioids were intended for long-term use, Alexander noted.
Even as late as 2012 to 2018 — when the impact of the opioid epidemic had been widely documented across the country — the FDA still approved 16 new prescription opioids based on