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Big Pharma was supposed to self-police fentanyl prescriptions

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Wronful Opioid Prescriptions

The Food and Drug Administration knew for years that rogue doctors were wrongly prescribing the most potent opioids on the market by subverting the agency’s oversight program.

Yet the FDA accepted the word of pharmaceutical companies administering the program that they were properly policing the doctors.

But they weren’t, and patients died.

Nearly 5,000 documents, obtained by InvestigateTV through a Freedom of Information Act request to the FDA, paint a picture of lax oversight and missed opportunities to clamp down on the fentanyl prescription abuses.

The records show the FDA knew the dangerous drugs intended only for cancer patients who were already taking opioids were also prescribed by the doctors for non-cancer patients.

The FDA ceded virtually all control of the oversight program to the drugmakers of transmucosal immediate-release fentanyl (TIRF) opioids that are as much as 100 times stronger than morphine.

A Lawyer’s Critique of A Broken System

Critics of the program, such as New York lawyer Richard J. Hollawell (pictured right), compare the agency’s TIRF-REMS oversight and safety program to the fox watching the henhouse.

“The FDA conceded all control to the drug industry and it’s disgusting,” he said.

Hollawell represents parents who lost their 32-year-old daughter to a Subsys overdose and a New Jersey mother who became addicted to the drug. Neither had cancer. Neither was protected by the oversight program.

“The FDA holds itself out that it is the gatekeeper for the protection of the consumer. The FDA is doing the opposite,” Hollawell said.

“They are allowing the industry to dictate how these drugs get to consumers, and it’s all in the interest of the drug industry.”

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