March 03, 2023
By: Senators Joe Manchin and Mike Braun
If FDA won't combat opioid crisis, this Republican and this Democrat will
Jessica Grubb of Charleston, West Virginia was 30 when she died unexpectedly. Lauren Cole of Morgantown, West Virginia was only 26 when she died unexpectedly. These tragic deaths and thousands more across West Virginia, Indiana and the United States have one thing in common – they died from opioid related overdoses, leaving their families, friends, and communities reeling. Unfortunately, their circumstances are not unique.
Approximately 200 Americans die every day from an opioid related overdose. In the last year, more than 106,000 Americans, including more than 1,400 West Virginians and 2,750 Hoosiers, died from overdoses related to opioids and synthetic opioids. That’s more than 106,000 fathers, mothers, sons, daughters, husbands, wives, brothers, sisters, and cousins who leave behind devastated families and loved ones.
This is a devastating and unacceptable number – the highest ever recorded in a single year.
The start of this epidemic can be traced back 28 years ago with the broad approval of OxyContin. In the years since, the Food and Drug Administration (FDA) has done very little to learn from their mistakes and change how they approve and manage highly addictive and deadly drugs. Instead of reining in prescriptions opioids, they have approved more powerful and addictive versions.
The drug epidemic has touched every community and family across America without discrimination. But communities in our home states of West Virginia and Indiana face disproportionately high overdose rates, coupled with limited access to substance use disorder treatment, prevention and recovery services. It is crystal clear that the FDA has failed to combat this crisis, and is even facilitating the drug epidemic’s continued devastation in West Virginia, Indiana and across the United States. Their complacency has persisted while the drug epidemic has claimed nearly a million American lives since 2001.
Last Congress, we introduced The FDA Review of Efficacy of EERW Double-Blinds (FREED) of Opioids Act, and we fought for its inclusion in the FY23 year-end funding bill. The legislation requires scientific experts to review the controversial methodology used for opioid approvals and ensure they are only marketed for uses where they are both safe and more effective than a non-opioid medication would be. The FDA recently announced their plan to implement this legislation. It is past time the FDA thoughtfully considered public safety in their drug approval process, rather than watching from the sidelines. This is a positive step, but there is much more that can and should be done.
That is why we have partnered to introduce four pieces of commonsense, bipartisan legislation that will reform the FDA’s drug approval processes and reduce opioid related overdoses saving American lives.
The FDA has only recently begun taking steps to acknowledge and address the massive scale of the opioid crisis in the United States, and its legacy of inaction requires an entire internal cultural shift. The Changing the Culture of the FDA Act would amend the FDA’s mission statement to explicitly take responsibility for protecting Americans from substance use disorder and overdose deaths throughout its approving, manufacturing and marketing of opioid medications. Our Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act would give the FDA authority to deny a new opioid drug application if the drug is not clinically superior to other commercially available drugs.
In addition, our FDA Accountability for Public Safety Act would require an advisory committee to review any new opioid medication before the FDA makes a decision about its approval. The legislation would also strengthen Congressional oversight by mandating that the agency submit clear, justifiable reports should it disagree with the recommendation of the advisory committee.
Prescription opioids sold in the United States have nearly quadrupled since 1999 despite no reported increase in pain, so it comes as no surprise that overdose deaths involving opioids have also quadrupled since 1999. We introduced the Protecting Americans from Dangerous Opioids Act to require the FDA to remove one opioid currently on the market for every new opioid medication they approve and would instruct the agency to prioritize revoking approval for unnecessary, deadly drugs.
We are proud to lead the fight in Congress to ensure no other family has to endure the pain of losing a loved one to drug overdose, like Jessie, Lauren and thousands of other West Virginians and Hoosiers. This fight is far from over, and we know that the only way to defeat this epidemic is to work together across party lines. We encourage our colleagues on both sides of the aisle to join our efforts to pass these commonsense reforms that will protect countless West Virginians, Hoosiers and Americans from this crisis that continues to harm our fellow Americans every day. It is time for the FDA to take action to make meaningful changes in the fight against the drug epidemic.
By: Senators Joe Manchin and Mike Braun
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