FDA Approval of Insys Fentanyl Drug Preceded Overdose Crisis

By Llewellyn Hinkes Jones

Deaths related to the opioid fentanyl have skyrocketed in the last few years, growing almost one hundred-fold since 2013.

The growing death rate from fentanyl by itself has caused the overall overdose death rate to grow by about 50%.

While the Trump administration has accused China as responsible for exporting much of the fentanyl into the U.S., the drug was not an issue until a slew of fentanyl variants manufactured by Insys Therapeutics were legalized by the Food and Drug Administration (FDA).

Fentanyl has existed for over half a century, but in the last decade new variants with patented release mechanisms have come on the market right before the overdose spike.

Abstral was approved in 2011. And so was Lazanda. Onsolis was approved in 2009.

But it was Subsys—a fentanyl sublingual spray intended for severe cancer-related pain that could not be properly treated with other approved remedies—was approved by the FDA in January of 2012 that was the big hit immediately preceding the overdose epidemic.

Risks associated with these drugs and potential for abuse was well known, and the FDA published a risk assessment , noting that all prescribers and distributors of these transmucosal immediate release fentanyl (TIRF) drugs had to undergo a risk evaluation and mitigation strategy (REMS) program. The TIRF REMS was approved in December of 2011.

But testimony from two doctors with Johns Hopkins in 2018 criticized the FDA’s oversight and noted that the agency had loosened its own restrictions on TIRF drugs. Doctors were prescribing the drug for non-cancer pain and for patients who did not meet the criteria for requiring such strong opioids by being “opioid tolerant.”

After its drug was approved, Insys began showering doctors and researchers with money, spending over $48.5 million since 2013 according to Medicare’s Open Payments data.

Medicare Part D spent over $163 million on Subsys in 2015 alone according to ProPublica’s Prescriber Checkup data .

Abstral, the only other new fentanyl variant that appears in that data, shows less than $19 million in spending in total .

The Department of Justice recently brought charges against Insys over accusations that it paid kickbacks to promote the drug.

Published: April 10, 2019