Press Release

E&C GOP Leaders Reactivate Investigation into Top Opioid Manufacturers


01.14.20

WASHINGTON, DC – 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) are renewing an investigation into the role of top opioid manufacturers in the ongoing opioid crisis. In letters to Insys Therapeutics, Mallinckrodt Pharmaceuticals, and Purdue Pharma, the lawmakers press for further answers from the manufacturers to an August 2018 inquiry into the three manufacturers.

“We are continuing our work investigating the causes and effects of the opioid epidemic. Last Congress, the Committee on Energy and Commerce began bipartisan investigations into fentanyl, opioid manufacturing, opioid distribution, and the substance use disorder treatment industry,” the leaders write in the letters. “We write today to reactivate the investigation started on August 2, 2018, that examined potential breakdowns in the controlled substances supply chain, which may have contributed to the nation’s opioid epidemic, and the role of certain opioid manufacturers in such potential breakdowns.”  

In the August 2018 letters, which were sent in the midst of the Energy and Commerce Committee’s historic work to combat the opioid crisis, the manufacturers were asked to provide detailed information about their company’s actions related to the spread of the nationwide epidemic, including:

  • Questions to Insys about an alleged kickback scheme designed to boost sales of Subsys, a sublingual fentanyl spray.
  • Questions to Mallinckrodt about the company’s efforts to monitor its opioid sales for suspicious orders.
  • Questions to Purdue Pharma about when the company first knew about the dangers of OxyContin, which was approved by the Food and Drug Administration (FDA) in 1995 and available for use the following year.

The lawmakers are renewing this investigation, with specific questions unique to each manufacturer, the responses received following the August 2018 inquiry, and new developments since the original investigation was opened.

In the letter to Insys, the leaders note that the company’s response to the August 2018 inquiry was insufficient, and demand a full response the questions posed in the original inquiry by February 10, 2020.

In the letter to Mallinckrodt, the leaders request a briefing from Mallinckrodt officials regarding testimony by a senior company manager that faults with the manufacturer’s suspicious order monitoring (SOM) system were known internally at the company, but Mallinckrodt leaders failed to act.

In the letter to Purdue Pharma, the leaders demand responses to ensure all questions were answered by Purdue in the August 2018 inquiry, and question the company about the company’s response and subsequent marketing actions following a 2001 decision by the FDA to change OxyContin labeling, effectively allowing long-term use of the powerfully addictive painkiller, despite the lack of research showing it was safe or effective for long-term use.

These letters come as Committee Republicans last year pressed the Drug Enforcement Administration (DEA) and top opioid distributors for an update on recommendations of a report on pill dumping in West Virginia, launched a new phase in the patient brokering investigation, pressed the Administration for an update on SUPPORT Act implementation in August, and  – at the start of the new Congress – called for a continuation of bipartisan work to combat the opioid crisis. Committee Republicans also released 12 bills Congress could consider right now to further our efforts to combat this scourge.

For more information about Energy and Commerce’s comprehensive efforts to combat the opioid crisis, CLICK HERE.

CLICK HERE to read the latest letters.

Press Release