Republican representatives question FDA on oxycontin label change


Republican leaders in the House Energy and Commerce Committee asked the U.S. Food and Drug Administration why it approved a label change for OxyContin in 2001.

Committee members Reps. Greg Walden (R-OR), Brett Guthrie (R-KY) and Morgan Griffith (R-VA) sent a letter to FDA Commissioner Stephen Hahn on Thursday, asking for more information on the department’s belief that the label change did not contribute to the opioid crisis.

The label change in question concerned the FDA’s approval of language that specifically addressed chronic, long-term pain as a symptom Purdue Pharma’s OxyContin could treat.

“On August 8, 2019, the FDA provided a briefing to bipartisan Committee staff in response to the June 25, 2019 request letter. During the briefing, the FDA maintained that the 2001 label change did not contribute to the worsening of the opioid crisis. In support of its contention, the FDA provided data showing the estimated number of prescriptions dispensed for extended release oxycodone generally did not increase after the 2001 label change, during the same time when prescription opioid use was increasing. The FDA data showed that the number of extended release oxycodone prescriptions made up a very small and decreasing fraction of opioid prescriptions,” Walden, Guthrie, and Griffith wrote.

The lawmakers argue that the FDA should provide additional context and data standardization regarding the oxycodone prescribing data.

“Standardizing data for comparison is important given that, while FDA believes it only intended to narrow the indication for OxyContin, the 2001 label change may have been used to help promote higher-dose, longer-term prescriptions, and thus could have facilitated prescriptions of Extended-Release and Long-Acting (ER/LA) oxycodone. Purdue internal documents indicate that the company may have viewed the effect of the label change effect as an opportunity to expand its market. For example, Purdue’s 2002 Budget Plan explained how they planned to take advantage of the new language: ‘The action taken by the FDA to clarify the OxyContin Tablet labelling has created enormous opportunities,’” the lawmakers wrote.

Between 2001 and 2008, OxyContin because the top drug for abuse as opioid sales sky-rocketed, doubling to $2.3 billion in sales from 2007 to 2008.