Category Archives: Past Calls to Action

Submit your comments to the FDA

The FDA is looking into how naloxone can be made more available.  They’ll be having an Advisory Committee meeting on December 17th and 18th to discuss this matter.

The FED UP! Coalition has long advocated for ready access to naloxone. Too many people have died because they did not have naloxone readily available.

The FED UP! Coalition plans to communicate to the FDA:

  1. All forms of naloxone should be sold over the counter
  2. The Federal government should subsidize over the counter naloxone to keep the price under $20 per dose.
  3. The Federal government should launch a public awareness campaign regarding Naloxone to cover such issues as:
    • Should you have naloxone in your home or place of business?
    • How do you know when to administer naloxone?
    • How do you administer naloxone?

The FDA is also asking what has worked in your community to expand naloxone access and in what circumstances you believe that naloxone should automatically be prescribed when an opioid is prescribed.  You may want to let them know your opinion on these issues as well.

Comments sent by Friday, Dec. 14, 2018, will be reviewed by the FDA Advisory Committee.

SUMBIT COMMENT

Send a comment to the FDA, supporting our petition to remove ultra high dosage unit opioids from the market

Dear FED UP! Friends,

We need your help to have ultra-high dosage unit opioids removed from the market. These are pills so strong that just one could cause an overdose in someone not used to taking opioids.

We have joined PROP, Shatterproof, the National Safety Council and ASTHO, the organization for state health commissioners, in petitioning FDA for removal of these products.

We believe that ultra-high dosage opioids can be removed without any burden or hardship for patients who need high doses, like people with advanced cancer. Patients will still have access to the same opioids. The only difference is that they will have to swallow more pills at one time if they are on extremely high doses. For patients who can’t easily swallow extra pills, opioids are available as liquids and patches.

We know this will not solve the opioid crisis, but if the FDA does what we’re asking, lives will be saved.

If you have questions about this effort, please read our fact sheet.

You can help by leaving a comment on the FDA Docket. Just click here.

1. When you leave a comment, please begin by saying something about your personal experience. If you know someone who became opioid addicted by taking prescription opioids, even if they switched to heroin, please mention it.

2. Please state clearly that you are strongly supporting the petition.

3. Please explain why you support the petition. For example, you can write:

The risks of ultra-high dosage opioids outweigh the potential benefit. An opioid so strong that just one pill can kill should not be on the market. You can remove these products without hardship for patients. Patients who need high doses can swallow more pills at a time. We have lost too many lives already. Removing these products will not solve the opioid crisis but it will help. Please do the right thing. Please seek removal of ultra-high dosage opioids.

4. After you leave a comment, please ask someone you know to do the same.

Urgent Request to send Comments – FDA Docket Closes December 28, 2017

The FDA is seeking comments from the public about steps they can take to address the opioid crisis. Please go to the federal website to leave a comment – and please do this now because the docket will close in a matter of days. Deadline: December 28, 2017

Read FED UP!’s letter to FDA Commissioner, Scott Gottlieb

Leaving a comment is easy. It just takes a few minutes. Here’s how to do this:

  • Step 1: Click on the link at the bottom of this message
  • Step 2: Enter requested information
  • Step 3: Enter your comment:

Start with a couple of sentences about how the opioid crisis has impacted you. If you have a loved one that became addicted from taking opioid painkillers, please make sure to mention it- even if your loved one switched to heroin. If you want to thank FDA for seeking comments, that would be nice.

Here are some suggested points you should make in your comment:

  1. FDA should overhaul its opioid policies- as recommended by the National Academy of Sciences in a recent report.
  2. FDA should prohibit drug companies from promoting long-term use of opioids as safe and effective for chronic pain.
  3. FDA should remove dangerous ultra-high dosage opioids from the market.
  4. FDA should stop approving new opioids- we can’t handle the ones we have now.
  5. FDA should make education about addiction mandatory for prescribers who want to give more than a 3-day supply of opioids.
  • Step 4: Submit comment
  • Step 5: Encourage someone you know to also leave a comment.

Submit comments on FDA’s newly established
Opioid Policy Steering Committee
Deadline: December 28, 2017