Court documents reveal Dr. Gottlieb served as expert witness defending fentanyl maker’s off-label marketing

Washington (April 27, 2017) – Senator Edward J. Markey (D-Mass.), along with Senators Elizabeth Warren (D-Mass), Maggie Hassan (D-N.H.), Sheldon Whitehouse (D-R.I.) and Sherrod Brown (D-Ohio) today sent a letter to Food and Drug Administration (FDA) nominee Dr. Scott Gottlieb requesting details about the nature of the work and financial relationship he had with fentanyl manufacturer Cephalon.

Publicly available court documents indicate that, following Dr. Gottlieb’s tenure at the FDA and as the prescription opioid epidemic was exploding, he served as an expert witness in federal court on behalf of Cephalon, and crafted and submitted an expert report opining on the proprietary of Cephalon’s actions. The company had already plead guilty in 2008 to illegally promoting the fentanyl drug and paid a $425 million fine. Dr. Gottlieb’s publicly available financial disclosure statements prepared in connection with the Senate confirmation process does not include detailed information about his work. At his Senate confirmation hearing, Dr. Gottlieb stated that the opioid epidemic is “the biggest public health crisis facing the FDA.” 

“We agree that immediate action is needed, and that the FDA is a critical partner in this public health fight,” write the Senators in the letter to Dr. Gottlieb. “However, we are concerned about the disjuncture between these statements and your work as an expert witness, paid to defend the actions of a company that pled guilty to criminal charges that it promoted its fentanyl product for off-label uses other than what the FDA approved.”

A copy of the letter can be found HERE.

A Washington Post story earlier this week reported that Dr. Gottlieb advocated on behalf of Cephalon while he was previously employed at the FDA, in an attempt to increase the amount of fentanyl the manufacturer could produce. These activities occurred at the same time the company was under federal investigation for pushing doctors to prescribe the addictive painkiller for headaches and back pain when it was meant for late-stage cancer patients. Ultimately, the DEA denied the request, finding that Cephalon and the FDA had no basis for this increased allotment.