FDA Advisors Petition Due to ‘Dangerously Deficient Oversight’

In a petition sent to the Food and Drug Administration (FDA) this week, two FDA advisors are claiming the agency has suffered “dangerously deficient oversight” in its approval of new prescription Opioids in the past decade. Dr. Sidney Wolfe (former drug safety committee advisor to the FDA) and Dr. Raeford Brown (current chair of the FDA’s Opioid advisory committee) are leading the FDA advisors petition to have the agency to suspend approvals until “it finishes developing a framework for such approvals.”

Between 2009 and 2015, the FDA approved 27 new Opioid painkillers.

The FDA must respond to the petition formally, something Drs. Brown and Wolfe hope to use in their collective effort to push governing bodies to further address their roles in the Opioid Epidemic. Since 1999, approximately 400,000 people have died from an overdose involving Opioids. Of over 70,200 drug-related deaths, 68% involved an Opioid in 2017.

“It is a national emergency,” said Dr. Wolfe. “There’s not one Opioid that’s been approved in the last 10 or 20 years that has any significant advantage in pain relief over existing ones and doesn’t just add to the probability of people getting addicted and abusing the drug.”

Dr. Wolfe, founder of the Public Citizen Health Research Group, claimed the regulatory body “can no longer be trusted” due to influence from the pharmaceutical industry, which provides a majority of funding for the FDA department responsible for certifying new drugs.

“The agency has been given every opportunity to act in the interest of the American public.”

In a call with reporters, Dr. Brown continued, “However, the agency has yet to respond to substantial changes suggested by the academies. Those of us that study the activities of the FDA have yet to observe behaviors indicating the agency is prepared to accept responsibility for the Opioid crisis and substantially change the regulatory framework.”

Improving the FDA’s Prescription Approval Process

This isn’t the first criticism the FDA has received during the Opioid crisis. After approving the drug Opana ER® (Oxymorphone), it quickly became popular among injection drug users and led to an outbreak of Hepatitis C and HIV. Six years passed before the FDA took Opana ER off the market. In 2018, the FDA approved Dsuvia® (Sufentanil, up to 1,000 times stronger than Morphine) despite a wave of criticism and ever-climbing Opioid-related deaths.

In 2017, the National Academies of Science, Engineering, and Medicine provided the FDA with a list of suggestions for improving the process for bringing new painkillers to market, upon the agency’s request in 2016. However, two years later, those recommendations have yet to be employed.

The report included making considerations for things like:
  • Benefits and risk to patients, their families, and the public
  • Crime
  • Unemployment
  • Effects on legal and illicit Opioid markets
  • Risk of diversion
  • Risk of transition to illicit drugs like Heroin

“The FDA’s continued approval of new potent Opioids, which are known to threaten the public health, without first significantly improving the review process by creating and finalizing an Opioid regulatory framework recommended by the National Academies represents a clear and present continuing danger to the health and safety of people in this country,” the petition said.

“Until improvements are made, the FDA does not have a framework to effectively evaluate [new drug applications] for new Opioids and new Opioid formulations to determine whether the legal standards for establishing safety and effectiveness are met. Thus, an immediate moratorium on Opioid approvals is needed urgently.”

Author: Destiny Bezrutczyk – Last Edited: March 26, 2019

Sources

Centers for Disease Control and Prevention. (2018). Understanding the Epidemic. Retrieved on March 22, 2019 from https://www.cdc.gov/drugoverdose/epidemic/index.html

Frieden, Joyce. (2019). Group Calls for Moratorium on FDA Opioid Approvals. Retrieved on March 22, 2019 from https://www.medpagetoday.com/psychiatry/opioids/78733

McGreal, Chris. (2019). Opioid crisis: FDA’s own staff demand agency halt approval of new painkillers. Retrieved on March 22, 2019 from https://www.theguardian.com/us-news/2019/mar/21/fda-opioid-approvals-halt