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E&C Republican Leaders Press FDA on OxyContin Labeling Change


Washington, D.C. – Energy and Commerce Committee Republican Leader Greg Walden (R-OR), Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY), and Representative Morgan Griffith (R-VA) sent a letter to Food and Drug Administration (FDA) Commissioner Stephen Hahn, M.D., to request information on the FDA approval of a OxyContin label change in 2001.

The inquiry follows a briefing FDA provided at the request of bipartisan E&C leaders, in which the FDA presented information they believed showed the opioid crisis was not exacerbated by their decision to approve the change to Purdue Pharma’s OxyContin label in 2001. The FDA provided data on the quantity of prescriptions dispensed, but did not present data on the opioid dosages or durations of the dispensed prescriptions, which may tell a different story on the impact of the label change.

“Thus, this additional context and customary data standardization should be taken into account in assessing the potential role the 2001 label change had on the opioid epidemic. Studies, documents, and other data support these concerns related to higher dosage and longer duration in oxycodone prescribing (including OxyContin prescribing) that contributed to the opioid crisis,” wrote Walden, Guthrie, and Griffith.

The members pointed to analyses that showed Purdue Pharma had a higher market share if measured by the dosage strength of the opioids, with one analysis showing Purdue was the top oxycodone manufacturer by this measurement.

“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 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,’” wrote Walden, Guthrie, and Griffith.

Following the 2001 FDA-approved label change, OxyContin progressively became a top drug for abuse while sales of opioids increased, even more than doubling to $2.3 billion in sales in 2008 from 2007. Earlier this year, E&C Republicans wrote to Purdue Pharma questioning Purdue’s response to the 2001 label change as part of the reactivation of an investigation  started by then-Chairman Walden into opioid manufacturers. E&C Republican leaders seek information about the FDA’s labeling decision process as part of their continued oversight work to better understand the causes of the opioid crisis and prevent future drug epidemics.

Click HERE to read the letter to FDA.

Press Release