Briefing Request Focuses on Failure of Fentanyl Prescription Safeguards and Lessons Learned from the Agency’s Decision to Allow Long-Term Use of Oxycontin
WASHINGTON, DC – A bipartisan group of Energy and Commerce Committee leaders sent a letter to Food and Drug Administration (FDA) Acting Commissioner Norman E. “Ned” Sharpless, M.D., today requesting briefings on two key agency actions related to the opioid epidemic. The Committee leaders are seeking information on the agency’s management of safeguards against high-risk patients being prescribed certain types of fentanyl products made by Insys Therapeutics and other companies that still resulted in inappropriate prescribing according to researchers. The leaders also want to learn more about the agency’s decision in 2001 that expanded the label for Purdue Pharma’s Oxycontin to cover chronic, long-term pain.
The letter was signed by Chairman Frank Pallone, Jr. (D-NJ), Republican Leader Greg Walden (R-OR), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Republican Leader Michael C. Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO), and Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY).
“We write to request information from [FDA] in response to recent reports concerning two agency actions related to opioids,” the bipartisan Committee leaders wrote to Acting Commissioner Sharpless. “Last year, the Committee initiated investigations of both Insys and Purdue Pharma. 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.”
Earlier this year, the Journal for the American Medical Association (JAMA) published an article that suggested up to 55 percent of patients who were administered highly potent forms of fentanyl had not built up the required tolerance to opioids in accordance with FDA’s highly restrictive prescription safety standards, which are formally known as the Risk Evaluation and Mitigation Strategies (REMS) program for Transmucosal Immediate-Release Fentanyl (TIRF) products. The JAMA article also noted a 2013 Health and Human Services (HHS) Office of Inspector General (OIG) report questioning the effectiveness of FDA’s fentanyl safeguards and issued recommendations for FDA to improve their effectiveness.
Separately, in 2001, FDA decided to allow Purdue Pharma to expand Oxycontin’s label for long-term use despite the lack of research showing it was safe or effective. Last year, Congress passed the bipartisan SUPPORT for Patients and Communities Act, which provided FDA with the authority to require post-market studies on long-term efficacy for controlled substance to treat pain and authorized that new information related to reduced effectiveness be included on the product label. In February, FDA announced that it will require drug companies to study whether prescription opioids are effective in quelling chronic pain.
In their letter to FDA, the members outlined several matters they would like FDA to address in the requested briefing, including:
- What is FDA’s assessment of its management of REMS for TIRFs, and what changes, if any, in managing the REMS program for TIRFs would help make the program more effective?
- What is the status of FDA’s implementation of the recommendations in the 2013 HHS OIG report?
- With regard to the 2001 Oxycontin labeling decision, does FDA see any lessons learned either in its original decision, and/or in its course of conduct after the decision?
- With regard to the 2001 Oxycontin labeling decision, what would FDA do differently in addition to requiring effectiveness research as recently authorized by the SUPPORT Act?
Letter to FDA available HERE.