Support our FDA Petition on Kratom Opioids

The FED UP! Coalition is submitting a Citizen Petition to the FDA urging action on a new and rapidly emerging class of kratom-derived opioid products.

These products increasingly include concentrated 7-hydroxymitragynine (7-OH), pseudoindoxyl compounds, and semi-synthetic derivatives designed to produce strong μ-opioid receptor activation. Unlike traditional kratom leaf, many of these products are engineered for opioid-like effects and are being sold in smoke shops, gas stations, and online without drug-level regulatory oversight.

Our petition asks FDA to clarify that products delivering substantial μ-opioid receptor agonist activity should be regulated as drugs, not as dietary supplements or conventional foods.

We are seeking support from individuals and organizations who agree that new opioid-like compounds should not enter the marketplace without appropriate safety oversight.

To read the full petition, press HERE.

SignHERE to support this petition.

Your name and organization may be listed publicly as supporters unless you request otherwise.

Last Chance to Object to Purdue Bankruptcy

There’s still time to let your AG and government officials know that you want them to object to the Purdue Bankruptcy plan.

A group called “Unleash the Mothers,” led by Susan Ousterman from PA, is spearheading last-minute efforts to block the Purdue bankruptcy. They’re at unleashthemothers@gmail.com if you need more information.

They sent an email to us stating:

We want to bring some important issues to your attention ahead of the Purdue Pharma bankruptcy confirmation hearing, which begins Wednesday, November 12th. What they are doing is worse than anyone expected. Of course, it shields billionaires, but also includes coercive third-party releasespits surviving victims against one another, and forces claimants to vote/consent before knowing if their claim is viable. They are aggressively rejecting personal injury claims, and the plan diverts $750 million to the Sacklers’ defense while only a fraction reaches victims’ families. 

And just today, they filed an amended version of the plan that includes significant changes, and a provision that doesn’t require a new vote by claimants. So, essentially, this is a different plan than the one voted on! Some of those changes are:

  • Expanded Administrative Discretion and Claim Filtering
  • Broadened Sackler Immunity and Indemnity Protections
  • Weakening of Public Benefit Company Obligations
  • Violation of Disclosure and Consent Principles

We’re asking EVERY claimant, advocate, and ally to withdraw support and contact anyone you have local connections with, especially your state Attorney General, Governor, or county officials, and urge them to:

*Withdraw support for the Purdue bankruptcy plan and finally stand with victims.*

You can personalize the attached letter or write your own, then email it to your local officials ASAP. You may also include the attached fact sheet. If you prefer calling, a phone script is provided as well. I know it’s late in the game, but even sharing this message can make a difference.

We can’t bring back our loved ones, but we can honor them by using our voices for change. We know the harms of drug policy run much deeper, and this moment isn’t just about Purdue; it’s about exposing how our legal system continues to protect power at the expense of truth.

Unleash the Mothers

Here’s the sample letter they’ve recommended sending and/or a script for a phone call.

Email Template to Attorneys General, Governors, or County Officials (feel free to edit to use examples of issues in your state, and personalize before copying into an email)

Subject: Urgent Request: Withdraw Support for the Purdue Pharma Bankruptcy Plan

My name is ____________, and I am directly impacted by the opioid crisis. [Optional: share your story] I am writing to bring your attention to critical flaws in the Purdue Pharma bankruptcy settlement plan. As it stands, this plan is poised to deliver a second injustice to opioid victims and the public. We also don’t need more “abatement funds” that sit unspent. The argument that funds are needed to abate the crisis no longer holds water. Pennsylvania is set to receive $200 million from this settlement, and currently has $260 million sitting unspent, collecting interest. They are asking plaintiffs for extensions to spend this money while overdose deaths remain extraordinarily high and bereaved families suffer.

Below are the major issues undermining the fairness and integrity of the Purdue settlement:

  • Secret Rewrite After the Vote: The 16th Amended Plan, filed on 11/7/25, after the voting and objection deadlines had passed, made material changes without re-solicitation—altering the very deal victims believed they were voting on. These changes include: (1) further restricting eligibility for Neonatal Abstinence Syndrome (NAS) claims and potentially reclassifying them outside personal injury compensation; (2) revising definitions that narrow the scope of what counts as a qualifying opioid-related injury; (3) tightening claim documentation requirements in ways that will disqualify more victims after the fact; and (4) modifying language that expands the Sacklers’ protection by adjusting release scope and enforcement provisions. These late-stage edits exploit procedural loopholes to retroactively limit payouts and shield non-debtors—all without claimant input or judicial scrutiny based on the actual plan now in effect. This is legal sleight of hand, not justice.
  • Coerced Legal Immunity for the Sacklers: A “yes” vote on the plan didn’t just approve the deal, but it also forced victims to release the Sackler family from all civil liability. Many claimants did not realize that by voting in favor, they were waiving their right to sue the Sacklers. Those who refused to sign away these rights were designated as having “Partially Channeled Claims” and made ineligible for payout. In short, the Sacklers’ legal protection was effectively bought using the desperation of victims, raising serious due process concerns (and stretching bankruptcy law beyond its limits in §524(e)).
  • Deceptive Approval Rate and Flawed Voting Process: The plan’s backers claim it had “over 95–99% approval” from claimants. This is deeply misleading. Of the 640,000+ who filed personal injury claims, fewer than 60,000 had their votes counted. Many never received ballots or were disqualified after voting, yet their votes were still included in the tally. Worse, ballots were sent before most claims were vetted, meaning people voted without knowing if they were eligible or how much they’d receive. This violates basic principles of informed consent and undermines the legitimacy of the vote under 11 U.S.C. §1125(b).
  • Victims Get Pennies While Lawyers Get Billions: The plan’s balance of payouts is fundamentally unjust. Total professional fees and expenses in this bankruptcy exceed $1 billion, including a special reserve to fund the Sacklers’ own defense costs. Meanwhile, the pool earmarked for individual victims is under $800 million, amounting to a few thousand dollars per victim at best. That’s less than 1% of the nationwide opioid settlement funds, a shockingly small share for those who suffered most. It’s galling that many of the same firms who pursued these cases now profit more from managing the settlement than the victims receive, posing a profound conflict of interest.
  • “Public Benefit Company” in Name Only: Purdue will emerge from bankruptcy as NewCo, supposedly a Public Benefit Company (PBC) meant to serve the public good. In reality, this is largely a branding exercise. Under Delaware law (DGCL §362), a PBC must have a specific public-benefit purpose beyond profit. Yet NewCo plans to continue business-as-usual, focusing on patenting new drugs (like a very harmful overdose antidote), with no governance role for victims or the public. By failing to center its mission on remedying the opioid harm, NewCo falls short of any genuine public benefit standard.
  • Settlement Funds Misused and Opportunities Wasted: The billions already flowing into states are NOT being directed to fully repair the damage done. State attorneys general won large awards by citing the past costs of the crisis (healthcare, law enforcement, etc.), however, they are barred from using the money to reimburse those past harms. Instead, funds must flow into narrow “opioid abatement” projects, many of which are slow-moving, duplicative, or unproven. As a result, much of the money remains unspent or collecting interest, rather than improving access to effective treatment or helping families in need.
  • We call on every public official of conscience to demand better, to stand with victims, and to prioritize healing over optics. This is your moment to reclaim the moral authority of your office and restore public trust. The Vilomah Foundation stands ready to steward this work in the public interest, ensuring that the next chapter of this tragedy is defined by scientific progress, transparency, and compassion.

As surviving family members, we supported the idea of abating this crisis, but we feel again betrayed by the lack of integrity in the process. We cannot bring our loved ones back, but we honor them by standing in truth and fighting relentlessly for those still here. We invite every official to join us in that mission.

The confirmation hearing begins November 12th. This is the moment for leaders who are not afraid to confront a broken system and choose the right side of history. We know there will be no true justice in a world where the Sacklers walk free, but you still have the power to do what is right: withdraw your support for this deeply flawed bankruptcy plan and honor our children’s lives.

Thank you for your attention to this urgent matter. We have solutions, and we want to work with you on achieving the best outcomes, but first we must stop this plan from being approved! Please stand with victims and help us ensure this settlement truly serves the public interest.

Sincerely,

[Your Name & contact information]

Phone Script for Calls to Public Officials

Hello, my name is [Your Name], and I am a directly impacted individual from [Your City/State]. [Optional: share your personal story].  I’m calling to urge [Official’s Name] to withdraw support for the current Purdue Pharma bankruptcy settlement plan before the confirmation hearing next week. You will hear the narrative that 95% of claimants agree, but that is misleading. The overwhelming majority of personal injury claimants DO NOT support this plan; it is fundamentally flawed and unjust. Maintaining support for it betrays the victims of the opioid crisis and erodes public trust. I am happy to send you more information. Thank you for your consideration.

Letter to Sec. Kennedy regarding Overdose Data to Action (OD2A) program

July 27, 2025

The Honorable Robert F. Kennedy, Jr.
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC  20201

Re: The Overdose Data to Action (OD2A) program

Dear Secretary Kennedy:

              We, the member organizations of the FED UP! Coalition to End the Opioid Epidemic, believe that the CDC’s Overdose Data to Action (OD2A) Program is vital in the fight against the opioid epidemic. There has been confusion about whether $140 million will be withheld from OD2A; as a result, some involved agencies are halting planned programs.

              Our organization was formed in 2012 by parents from across our country who had lost children to the opioid epidemic and who first met at FDA Advisory Committee meetings about new prescription opioids. These bereaved parents came, at their own expense, to tell the FDA that it had underestimated the dangers of prescription opioids. They formed FED UP! to do everything they could to engage the federal government regarding issues that they considered vital in the opioid epidemic.  Since then, most of our work has been connected with agencies now under your control.

While we have frequently criticized federal government programs, we believe that OD2A is uniquely valuable. Components of street drugs change rapidly; OD2A helps local and state health departments collect timely and comprehensive data on drugs and drug overdoses and use those data to enhance overdose prevention. Much of the work of OD2A involves building partnerships among public health, healthcare systems, law enforcement, first responders, and community organizations, allowing them to take rapid action based on the collected data.

It is tempting to believe that we have the opioid epidemic on the run. Overdose deaths have diminished. The DEA attributes this decrease to its hard work fighting the cartels, leading the cartels to have to spread their product more thinly. Fentanyl powder purity and the dose of fentanyl in counterfeit pills have both decreased.  Naturally, we are pleased with these results, but there are many threats that could rapidly exacerbate the opioid epidemic. The cartels have a history of shifting products when things get hard. Ten years ago, the preponderance of opioid deaths were from heroin. The cartels replaced heroin with fentanyl because it was a more dependable product and, given its higher potency, easier to smuggle. Overdoses with even higher potency opioids, such as carfentanil and nitazenes, remain uncommon but are on the increase. 

OD2A acts as a DEW line in our effort to counter those threats.

We urgently request that you review this situation and make sufficient funding available to OD2A to allow it to perform its critical function. We would certainly be willing to meet with you and/or your team to discuss our concerns about OD2A as well as other ways we can collaborate in addressing this national health emergency.

Sincerely,

Daniel Busch, M.D., M.P.H.
Chair, FED UP! Coalition

Changes in FDA Prescribing Information for Opioids

FED UP! is pleased with the new FDA prescribing information for prescription opioids, which places greater emphasis on the risks of opioids, of higher doses of opioids, and of longer-term continuation of opioids.  

However, the new prescribing information continues to underestimate the risks of opioid addiction. It discusses results of two studies of new opioid users, and says the rate of development of addiction over 12 months on opioids was 1-6%, defining addiction as moderate-severe opioid use disorder, using DSM-5 criteria.

  1. The 6% figure includes only moderate-severe OUD.

What about mild OUD?

The medical term for addiction is opioid use disorder. That includes mild OUD.

Mild OUD is not a benign condition. Addiction is a progressive illness. Mild OUD frequently goes on to become moderate-severe OUD.

The most recent NSDUH study found that mild OUD is approximately twice as common as moderate-severe OUD.

If that ratio applies here, approximately 18% of those in the study developed OUD using the DSM-5 definition, not 6%.

  • The 6% figure uses the DSM-5 definition of (moderate to severe) opioid use disorder. This definition is automatically modified so that physiologic effects of chronic opioids (dependence, withdrawal) are not counted toward opioid use disorder.

Although the prescribing information says the 1% figure comes from DSM-5 criteria, it does not. The 1% figure comes from criteria newly developed for this study.  The criteria remove a number of the DSM-5 criteria if the patient says they are motivated by a desire to reduce pain.

We know that addiction is a disease of denial. Many people who are developing addiction believe they are taking medication to reduce pain.

We will be requesting that the FDA correct these underestimates of the incidence of OUD in these two studies, so that prescribers and patients will be better able to assess the risks of prescription opioids.

UNIVERSAL AVAILABILITY OF MAT

MAT SAVES LIVES: It decreases opioid overdose deaths by more than 50%

But it’s underutilized:

  • The majority of those who receive treatment for OUD do not receive MAT
  • Cost, availability, and stigma are the biggest reasons.

MAT utilization is particularly inadequate among those who are:

 Poor

Uninsured

Homeless

Incarcerated

Rural

Racial Minorities

Adolescents

COST BARRIERS PLAY A MAJOR ROLE

Our Plan: A Ryan White Act for OUD

  •    The Ryan White Care Act of 1990 made HIV treatment available to all those who needed it regardless of insurance status. 
  •    The opioid epidemic cries out for a similar program, one that would ensure funding and access for treatment.
  •    We need a public service campaign. Naloxone is no longer stigmatized like it used to be. We need the same for MAT.

What is FED UP! Doing About This?

  • We are working with Congressional Representatives and Senators to introduce legislation to remove cost barriers to OUD treatment. 
  • We support all efforts to reduce stigma regarding MAT.

ACT NOW TO STOP YOUR STATE AND LOCAL GOVERNMENTS FROM USING OPIOID SETTLEMENT FUNDS TO PAY OTHER BILLS

Opioid settlement funds are supposed to be kept separate and to be used for education, prevention, treatment, and harm reduction.

But nothing in the settlement agreement prevents states or counties from using the Settlement Funds to pay for programs that are already funded while moving the money that is currently paying for these programs back into general funds!

Thirteen states and Washington D.C. have made “no supplantation” commitments to protect the opioid settlement money for its intended purposes: Connecticut, Delaware, Kansas, Maine, Maryland, Massachusetts, Michigan, Nevada, New Jersey, New York, Vermont, Virginia, and Wisconsin.

If your state is not on this list, the Opioid Settlement Funds in your state are vulnerable to misuse.

DON’T LET THIS ISSUE GET OUT OF HAND!

Call your state legislator today to set up a meeting. Let them know that the settlement funds were meant to supplement existing sources of funding, not supplant them, and that you want them to introduce “no supplantation” legislation for the Opioid Settlement Funds.

If you can’t meet with the legislator, meet with one of their aides. If you can’t get a meeting set up, write them!  (For a sample letter, see below.)

Feel free to get back to us with any questions at info@feduprally.org.

MAKE EVERY PENNY COUNT!

BACKGROUND

               The 1998 Tobacco Settlement resulted in payments to the states of $206 billion over 25 years. But only 2% of that money has gone to tobacco prevention and cessation programs!

               The Opioid Settlement Agreement was supposed to be different. Funds could only be used to pay for projects directed toward opioid remediation.

               FED UP! has been concerned from the beginning about misuse of these funds and has focused attention on this issue with our Make Every Penny Count campaign.

               We only recently learned that there is an even greater threat to the settlement money. Unless there are specific state laws, states, counties, and cities can use the Opioid Litigation Settlement money to pay for programs that are already being paid for, and then use the  money that is currently paying for these programs for some other purpose. This is called “supplantation” and the result is no net gain in funding for opioid remediation.

               John Oliver devoted his May 12th  program to misuse of the Opioid Settlement Funds. It’s at https://www.youtube.com/watch?v=Io0yuH1CiA0. He calls supplantation an “accounting trick.”

          Some states have passed strong “No supplantation” laws. Connecticut is an example: Connecticut Public Act No. 22-48, Section 2 (f) 6 states:

“Moneys expended from the [Opioid Settlement Fund] for the purposes set forth in subsection (d) of this section shall be supplemental to, and shall not supplant or take the place of, any other funds, including, but not limited to, insurance benefits or local, state or federal funding, that would otherwise have been expended for such purposes.”

https://cga.ct.gov/2022/ACT/PA/PDF/2022PA-00048-R00HB-05044-PA.PDF

Sample letter [[If anything has brought the opioid epidemic home to you, begin with that.]:

(Month)(Day)(Year)

The Honorable (First name)(Last name)

Address City, State (Zip Code)

RE: Save the opioid settlement money for its intended uses.

District Dear (Representative/Senator/Congressman or Congresswoman) (Last name):

I’ve lived in [Insert State] most of my life. Two months ago a student in my daughter’s high school class died of fentanyl poisoning. The same thing could have happened to my daughter. I know that [Insert State] has programs to educate children and to provide treatment, but it’s obviously not enough.  

          I was relieved when I learned that Opioid Litigation Settlement money was being sent to [Insert State]. That money is supposed to provide some of the additional help that is desperately needed.  

But then I heard that in some parts of the country, this money is being used as an easy solution for budget shortfalls. That isn’t the purpose of this money and we must not allow this to happen in [Insert State].

Please help us get “no supplantation” legislation passed to assure that money from the Opioid Settlement will be used for its intended purpose, not to pay for programs that already exist.

Sincerely, 

[Insert Name]

[Your address]

[Your phone number]

MAKE EVERY PENNY COUNT!! 100% of funds to help fight the Opioid Epidemic

States are in the process of determining disbursement of billions of dollars from the opioid related lawsuit settlements. FED UP! encourages those funds to be used only for tackling the opioid epidemic. Please contact your local State Attorney General’s office ASAP to find out how your state is handling the money.

Click here for more information State Opioid Settlement Funding Tracker

npr: States differ on how best to spend $26B from settlement in opioid cases