Lax government oversight fuels opioid crisis

The federal government has for several years entrusted regulatory control over the most potent painkillers to drug companies that helped fuel the nation’s opioid epidemic.

Fentanyl Oversight Problems

The painkillers — fast-acting addictive fentanyls meant for cancer patients in extreme pain — are so dangerous a special oversight program exists to regulate their distribution, prescription and safe use.

But lax oversight by the Food and Drug Administration and the program’s operator, McKesson Corp., has allowed some drugmakers and doctors to exploit the patient-protection program, a Raycom Media national investigation has found.

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Both the FDA and McKesson declined interview requests, answering questions only by email.

“The TIRF-REMS program is not a McKesson program,” company spokeswoman Kristin Chasen wrote. “The requirements of a REMS program are developed jointly by the manufacturers and the FDA with ultimate approval resting with the FDA.”

Yet the FDA hands off enforcement and discipline to the drug companies.

The relationship doesn’t sit well with Richard J. Hollawell, a New York lawyer who has been involved in opioid-related cases for the last decade.

“The (TIRF)-REMS program is a sham program. It’s a joke,” said Hollawell. “It’s put in place to make it look like they’re taking risk seriously. They’re not.”

FDA data illustrates Hollawell’s point. Hundreds of non-cancer patients reported adverse reactions from quick-acting fentanyls in just nine months last year.

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