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Americans Continue to Die as the FDA Refuses to Act

Public Citizen News / November-December 2019

By Mike Stankiewicz

This article appeared in the November/December 2019 edition of Public Citizen News. Download the full edition here.

Despite the opioid overdose epidemic continuing to claim lives every day, the federal government has failed to implement a detailed plan to help address the public health crisis that was issued more than two years ago by the esteemed National Academy of Sciences, Engineering, and Medicine.

The U.S. Food and Drug Administration (FDA) has moved too slowly and insufficiently in creating an updated regulatory framework for reviewing and approving new opioids, the agency’s recent, woefully inadequate draft guidance for assessing the risks and benefit of opioids proves how little the agency has done to help address America’s rampant opioid crisis, Dr. Michael Carome, director of Public Citizen’s Health Research Group, told the FDA at a public hearing on Sept. 17.

In June, the agency solicited public comment on a draft guidance that merely “encouraged” drugmakers to provide information that could help the agency determine the risks and benefits of a new opioid. This is inadequate because it is focuses on nonspecific, general factors that the FDA would consider when reviewing any new drug application instead of specific benefit and risk information of opioids, Public Citizen contends.

A stronger framework has been available for years. In fact, the FDA asked for it.

In early 2016, the FDA commissioned the National Academies to review the agency’s regulatory oversight of opioids and make recommendations for improving it. The National Academies in mid-2017 presented the FDA with detailed and in-depth recommended improvements for the opioid review and approval process.

But the FDA has not yet adopted them. Meanwhile, the agency approved the superstrong and dangerous opioid Dsuvia in 2018, which would never have occurred had the agency followed the National Academies’ recommendations.

“The FDA must make the development and implementation of an effective opioid approval framework its number one priority,” said Carome. “Had the FDA acted with the urgency demanded by the ongoing opioid crisis and begun the important process of developing desperately needed criteria when it received the National Academies’ recommendations more than two years ago, the framework likely would have been completed by now, rather than just beginning. Lives are at stake.”

In April, Public Citizen and Dr. Raeford Brown, then chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, filed a petition with the FDA to impose a moratorium on approval of all new opioids or new opioid formulations. In the petition, Public Citizen contended that the FDA should not approve any new opioids until the agency has implemented the National Academies’ recommendations.

The FDA denied the petition on Sept. 6, saying that it was developing a framework for approving opioids. But as the agency continues to craft what likely will be a watered-down process, thousands of Americans will continue to die.

Nearly 69,000 Americans died from drug overdoses in 2018, according to the U.S. Centers for Disease Control and Prevention, 12,757 of which were from prescription painkillers.

“The FDA has wasted valuable time,” Carome said. “Thousands of lives are being destroyed or lost in the opioid crisis, but the FDA has continued to approve increasingly potent new opioids.”