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# House Committee Asks Opioid Briefing
- URL: https://www.fdaweb.com/house-committee-asks-opioid-briefing/
- Published: 2019-06-25T12:00:00.000Z
- Updated: 2026-09-15T01:34:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144422

Bipartisan leaders of the House Energy and Commerce Committee are asking for information from FDA on two agency actions relating to opioids. In a 6/25 [letter](https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/FDA.2019.6.25.%20Letter%20re%20Opioids.pdf?ref=fdaweb.com) to agency acting commissioner **Ned Sharpless**, the legislators raise questions about **(1)** the agency’s management of safeguards against high-risk patients being prescribed certain types pf fentanyl products made by Insys Therapeutics and other companies that still resulted in inappropriate prescribing, according to researchers; and **(2)** the FDA 2001 decision that expanded the label for Purdue’s Oxycontin to cover chronic, long-term pain.

The letter covers research and news items that triggered committee members’ concerns and requests an agency briefing to address: 

- · the FDA assessment of its management of risk evaluation and mitigation strategies for transmucosal immediate-relief fentanyl products and any recommended changes to make the program more effective;
- the status of FDA implementation of recommendations in a 2013 HHS Office of Inspector General report on REMS effectiveness;
- lessons learned from the 2001 Oxycontin labeling decision;
- what FDA would now do differently on the Oxycontin labeling decision in addition to requiring effectiveness research as required in the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act;
- when drug manufacturers were notified of an agency requirement that they study the efficacy and sensitivity of opioid users to pain and when the research will be completed; and
- what additional steps the agency is taking to address and curb opioid and fentanyl abuse.