A new version of the painkiller OxyContin was supposed to deter snorting and injecting and reduce abuse. But neither the company that makes it nor the FDA has allowed experts to see the data to find out if it works.
FILE - In this Aug. 17, 2018 file photo, Christine Gagnon, of Southington, Conn., holds a sign during a protest with others who have lost loved ones to OxyContin and opioid overdoses, outside the Purdue Pharma headquarters in Stamford, Conn. Gagnon lost her son Michael 13 months earlier.
“We asked for that data probably 40 or 50 times in last four or five years and were denied every time,” said Brown, whose term as an FDA adviser ended in March. A Purdue spokesman said the Stamford, Connecticut-based company has been working to complete four updated study requirements assigned by the FDA in 2016. The company said it has submitted three of the FDA-mandated studies and expects to submit the final one by October.
The unreleased OxyContin data highlights the FDA’s precarious role as both a public health agency and close confidante of industry. While the agency can order a drugmaker to research important questions, the information itself still belongs to the company and is deemed “confidential commercial information.”
Those pills are intended to be difficult to crush, break or dissolve, but they can still be misused when simply swallowed. And the drugs carry the same addiction risks. But even the study authors acknowledge that those measures don’t necessarily reflect what’s happening across the country. Only a small segment of people misusing opioids ever enter rehabilitation, for instance.using a much larger dataset — a federal government annual survey — they found a different picture. Among people with a history of misusing prescription opioids, rates of OxyContin abuse were similar or higher three years after the drug was reformulated.
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