House E&C Committee Seeks Answers From FDA on Opioids
A bipartisan group of six congressmen on the House Energy & Commerce Committee sent a letter Tuesday to Acting FDA Commissioner Ned Sharpless requesting a briefing on the agency’s management of safeguards to restrict certain fentanyl products and regarding FDA’s decision in 2001 to expand the label for Purdue Pharma’s Oxycontin.The letter cites a February JAMA study that found that “thousands of patients receiving TIRFs [transmucosal immediate-release fentanyl medicines] were opioid-nontolerant.” The committee requests information on FDA’s assessment of its management of the risk evaluation and mitigation strategy (REMS) for TIRFs and what changes need to be made, and FDA’s implementation of 2013 recommendations from HHS’ Office of the Inspector General.
But the letter does not discuss how in March, FDA announced it was modifying the TIRF REMS program to require certain policies to verify opioid tolerance in patients who require TIRF medicines and to develop a new patient registry to monitor serious adverse events including overdoses.
On the topic of expanding the Oxycontin label, the letter cites a 60 Minutes report, entitled “Did the FDA Ignite the Opioid Epidemic?,” that explored FDA’s decision on Oxycontin given the lack of research showing that its long-term use was safe and effective.
With regard to the labeling decision, the committee asks FDA if there are any lessons learned and what the agency would do differently, in addition to requiring effectiveness research.
And with respect to former FDA Commissioner Scott Gottlieb’s announcement in February that FDA will require opioid manufacturers to conduct studies on the efficacy and sensitivity of opioid users to pain, the committee seeks to know if manufacturers were notified of the requirement to conduct such studies. The committee seeks information on whether FDA has reviewed protocols or study designs related to this new requirement, when this research will be completed and how the studies will be designed.
The representatives also explain how the committee initiated investigations last year into both Insys Therapeutics, which manufactures TIRFs, and Purdue Pharma, explaining how, “Information from FDA could be pertinent to these oversight interests as well as to continuing interest in FDA’s efforts to combat the opioid epidemic.”
Letter