UPDATE: We removed the call to action since the deadline passed. The meeting is 5/5/25. Here is the link with the meeting information including link to watch the all-day meeting and study results. 

We will post an update after the meeting.

What’s Going On With the FDA’s Opioid PMR Docket — And Why It Matters

We wanted to share something important that’s happening at the FDA and how you can get involved.

Back in 2012, PROP (Physicians for Responsible Opioid Prescribing) submitted a citizen to the FDA asking them to relabel all opioid medications, remove the word “moderate” from pain indications, impose a 100 MME/day cap, and restrict opioid use for non-cancer pain to just 90 days.

The FDA rejected most of PROP’s request, saying the science didn’t support strict dose or duration limits. But instead, they ordered a series of Postmarketing Requirements (PMRs) — long-term studies focused only on extended-release/long-acting (ER/LA) opioids to evaluate risks like addiction, overdose, and misuse. They had 11 studies. 3033-1 through 3033-11. Here is more info regarding results of 3033-3, 3033-4, and 3033-5.

In late 2024, the FDA opened a docket to begin reviewing those studies:
👉 Original docket here

But here's the twist - only one public comment was submitted before the docket closed… and it was from PROP. In their comment, they pushed the same narrative: that even patients who take opioids as prescribed may have OUD and the PMR studies wouldn't flag those patients, and so instead of discussing the studies, they should simply relabel long acting opioids. Ultimately, sounds like PROP is concerned that the studies will show that opioids work and few become addicted. This is the study PROP cited as evidence that five million pain patients taking their meds exactly as prescribed, and here is Kolodny's opinion piece about this from 2024.

👉 PROP’s comment on the FDA docket

👉 Submit your comment here

📝 What We Told the FDA

We submitted an official comment on behalf of The Doctor Patient Forum, pushing back on PROP’s dangerous narrative and calling for a more evidence-based, patient-centered approach. Our comment explains:

• Why PROP’s claims about OUD and prescribed use are misleading

• How Suboxone is being pushed using inflated misuse statistics

• Why the NSDUH data is deeply flawed (including Suboxone being listed as a “pain reliever”)

• The real harm being done to patients through forced tapers and loss of access

• And the need to protect individualized care and medication access

📌 We also asked the FDA to release the results of the two PMR studies that will be discussed at the May 5 advisory committee meeting, because as of now, those results have not been made public — making meaningful public input almost impossible. Their current plan is the release the information two days prior to the meeting. We asked for two weeks.

📄DPF's Comment on the docket - DPF's first comment

📄DPF's Comment on the docket - DPF's second comment submitted after study results were released

📝 Want More Information About How to Prove PROP's Claims Wrong?

• Join DPF's Patreon Page and go to Exclusive Patreon Videos
• Watch our in-depth video series on the DSM-5, the OUD diagnosis, the NSDUH survey, and how this is an industry funded narrative spun under the guise of "prevention." Part 3 will be out in a few days!

More info from FDA about the meeting

For those who are interested, here is a link that has the information and results from all of the PMR studies about opioids.

🙌 How You Can Help

This is one of the most important opportunities we’ve had to speak directly to the FDA and shape the record. If you’ve been affected by these policies — or know someone who has — your story matters.

✅ Submit your comment here: https://www.regulations.gov/document/FDA-2024-N-5331-0003/comment
📝 Say how opioid reduction policies have affected you. Discuss how opioids have helped you, and what your life has been like since losing access. Make sure to not just discuss pain relief but also focus heavily on function and ability to live a normal life, or your ability to work.
📣 Sample Comment (don't copy and paste it because FDA often discards form letter comments). Use some of it and personalize it.

📝 Sample FDA Comment (For Patients) - Please don't copy and paste because FDA often discards comments from form letters.

I’m writing as a chronic pain patient who relies on long-term opioid therapy to function. The medications I take are prescribed responsibly by my doctor, and they help me manage my condition so I can care for my family, work, and live a stable life.

I’m deeply concerned that comments like the one submitted by PROP suggest that even patients who take opioids exactly as prescribed may be classified as having Opioid Use Disorder. This is harmful and misleading. Just because someone is physically dependent on a medication doesn’t mean they are addicted.

Forcing patients off medications that work or pushing us onto Suboxone, which isn’t even approved for pain, could cause serious harm. I’ve seen friends suffer from forced tapers and medical abandonment, and many have ended up in the ER or worse.

I urge the FDA to protect access to individualized pain care and to release the full results of the PMR studies being discussed on May 5. Patients deserve transparency, and these decisions should be based on real evidence not ideology.

Please don’t let one group speak for all of us. Listen to the voices of patients who live with these policies every day.

Thank you.

When submitting a comment, when they ask for a category to choose from, you can leave it blank.

Thank you for continuing to fight with us — for truth, for science, and for the right to be treated with dignity.