Sens. Mike Braun and Joe Manchin
Since OxyContin was approved by the Food and Drug Administration in 1995, more than 500,000 Americans have died from overdoses related to opioids and synthetic opioids.
Nearly three decades later, more than 101,000 Americans – over 1,500 West Virginians and nearly 2,500 Hoosiers – died between June 2020 and June 2021. It’s clear that not much has changed in the way the FDA approves and manages these highly addictive, destructive drugs killing Americans at an astonishing rate.
In fact, it has become increasingly clear that the FDA has stood by, and even enabled, the pharmaceutical industry’s decision to choose profits over American lives.
Many families across the United States have been impacted by the drug epidemic that continues to ravage our nation. In our beloved states of West Virginia and Indiana, our communities continue to face disproportionately high overdose rates, with not nearly enough treatment facilities to care for our neighbors in need.
However, instead of reining in opioid prescribing, the agency in charge of regulating these substances continues to approve even more deadly opioids. It is crystal clear that the FDA has not done enough to address the drug epidemic ravaging our nation.
Given the dire situation facing our communities, it makes absolutely no sense to install a candidate who has already led the FDA in its most senior position but failed to address this crisis in any meaningful way. We need new, dedicated leadership that understands the gravity of the drug epidemic and will fight back against the greed of the pharmaceutical industry.
The current FDA commissioner nominee, Dr. Robert Califf, has significant ties to the pharmaceutical industry, and his leadership of the FDA would take us backward, not forward. His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.
During Dr. Califf’s previous tenure as FDA commissioner, drug-related overdoses went up, a clear indicator the FDA hadn’t made any necessary, meaningful changes to address the crisis facing our country. In 2016, then-Commissioner Califf announced the FDA’s plan to overhaul its opioid policies.
But between 2016 and 2017, the FDA approved five new opioids and only removed a single opioid from the market. Dr. Califf also commissioned a report on opioids, but the report failed to review the flawed enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids. While the FDA has sat back and allowed the drug epidemic to wreak havoc across our nation, we have worked to introduce legislation to implement simple changes that would help keep harmful opioids off the market. Last May, we introduced the bipartisan FDA Review of Efficacy of EERW Double-Blinds (FREED) of Opioids Act.
Our legislation would ensure that scientific experts review the controversial EERW methodology used to approve new opioids and will ensure that opioids are only marketed for uses where they are both safe and effective. Over three-fourths of the more than 100,000 drug overdose deaths this past year were caused by fentanyl and fentanyl-related substances. Our bill would address the incorrect marketing of dangerous opioids that do more harm than good and would force the FDA to act on this simple change to help ensure Americans are informed about the effects of dangerous opioids.
Reports have also indicated that Dr. Califf intends to keep Dr. Janet Woodcock on board as a senior adviser if confirmed to lead the FDA. During her tenure at the FDA, Dr. Woodcock has directly overseen the approval of numerous highly addictive drugs to market.
She also decided to ignore the advice of an FDA advisory committee when she chose to approve Zohydro, a questionable pure hydrocodone drug with strong risk of overdose and death.
The pharmaceutical industry has benefitted from the status quo at the FDA under the leadership of Dr. Califf and Dr. Woodcock, and the American people have suffered for it.
Here we are, six years after Dr. Califf first led the FDA, in the midst of the COVID-19 pandemic that has exacerbated the drug epidemic and only caused more harm and devastation for our families, our communities and those we hold dear. We need an FDA commissioner who is suited to handle the public health challenges our entire country is facing. That is not Dr. Califf.
The American people put their trust in the FDA to make decisions that will help them, not kill over 500,000 Americans and impact millions of lives forever. They deserve better from their federal government, and we must do better. The people instrumental in these detrimental choices cannot be allowed to remain in the same positions of power and influence.
There are other qualified, experienced leaders who can implement the culture changes so badly needed at the FDA who also understand the gravity of the drug epidemic and the role the FDA can play in fighting the greed of the pharmaceutical industry.
We will not vote to confirm Dr. Califf, and we again strongly urge President Joe Biden to reconsider his FDA commissioner choice and nominate fresh leadership to take over this crucial agency to help save American lives and rebuild our communities.