The Agency Must Enact 2017 National Academies Recommendations
WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) has acted slowly and insufficiently in creating an updated framework for new opioid approvals, and the guidance it has provided so far is woefully inadequate to address America’s rampant opioid epidemic, Dr. Michael Carome, director of Public Citizen’s Health Research Group, will tell the FDA at a public hearing today.
In June, the agency provided guidance that only “encouraged” drugmakers to provide information that could help the agency determine the risks and benefits of an opioid. Public Citizen contends that this is inadequate because it is focused on nonspecific, general factors that the FDA considers when reviewing any new drug application (NDA). The FDA instead should provide the industry with guidance as to what specific benefit and risk information should be sought out and included in future NDAs for opioids.
In early 2016, the FDA commissioned the National Academies of Sciences, Engineering, and Medicine 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 recommended improvements for the opioid regulatory review and approval process. The FDA has not adopted them.
“The FDA now must make the development and implementation of a new opioid regulatory framework its number one priority,” said Carome. “Had the FDA acted with the urgency demanded by the ongoing American opioid crisis and then begun the important public process of developing a desperately needed improved opioid regulatory framework soon after it received the detailed National Academies recommendations two years ago, it is likely that the process of creating this framework would have been completed by now, rather than just beginning. Lives are at stake.”
In April, Public Citizen filed a petition with the FDA to impose a moratorium on approval of all new opioids or new opioid formulations. The petition was in response to the FDA’s delay in implementing the National Academies’ recommendations. In the petition, Public Citizen contended that the FDA should not approve any new opioids until the agency has implemented the recommendations. The FDA denied the petition on Sept. 6, saying that it was developing a framework for approving opioids.
The FDA has wasted valuable time, Carome said. Thousands of lives are being destroyed or lost in the opioid epidemic, but the FDA has continued to approve increasingly potent and dangerous new opioids under a flawed regulatory framework.
Read the testimony (PDF).