Monday, May 7, 2012

Important! FDA Accepting Public Comments on Naloxone Availability

Last month OPA reported on a U.S. Food and Drug Administration hearing on strategies for improving access to naloxone. FDA is now accepting public comments until noon EST June 12, 2012. The more comments that FDA receives, the more likely our allies in the U.S. federal government will be able to push the issue.

You may submit comments individually or on behalf of an organization through this link, or by going to, searching for "naloxone" and clicking the link for "Role of Naloxone in Opioid Overdose Fatality Prevention."

Here are some suggestions sent out today by Harm Reduction Coalition's Whitney Englander:
(1) We need to generate VOLUME to FDA for the docket on the public workshop - numbers matter (2) The messages in the comments should be - as much as possible - to include references to the science, evidence, data, etc. - especially anything in the MMWR, or other data produced or published by government (e.g., NIDA, SAMHSA, FDA, CDC, etc.) (3) Any additional references to information or statements by other groups about the problem of overdose (e.g., data from American Hospital Association) and how naloxone will be a good remedy (4) We should extrapolate the data to illustrate what the "market" could be for naloxone -number of households with prescription opioids, number of American households with children/teenagers, etc.  anything to show that the potential market is bigger than what the industry rep suggested it is (5) Anything regarding economic impact - the cost of overdose - cost of emergency services/emergency department cost of someone who doesn't get emergency services right away and experiences brain damage from lack of oxygen, etc. - show the impact on society and economy (6) Be sure to make clear there is no adverse impact on people who do not have opioids in their system - science to illustrate this and anything regarding lack of side effects or nominal adverse effects - that the benefits FAR outweigh any possible problems with naloxone's use/expanded access.
And a few more guidelines from Maya Doe-Simkins:
On the comment page, fill in the fields and paste your comment of 2000 characters or less. 
All submitted comments are public record, which means that they are publically available, but comments from individuals will not be displayed on the website, unless you specifically request it.
Unless you are representing an organization, select "Individual Consumer" under the "Category" choice. 
You can use 2000 characters for an overview and submit a much lengthier statement as a PDF attachment, including letter on letterhead if available, graphs, figures, published papers, pictures, photos, etc. So, no need to feel constrained to 2000 characters if you have more to say!

Tips for crafting comments that may be helpful in expanding naloxone access:Comments should focus less on IF naloxone works, and more about the pros and cons of giving it to lay overdose bystanders and how simple (or not) that process is/should be. 
These are issues that have the potential to impede expanded naloxone access.  Consider addressing one or more in your comments if you are able:
  • Is the training simple?/ Do people feel well prepared to use it?/ If you did use it, could you/the person who used it easily remember instructions?
  • Does having naloxone increase drug use or decrease treatment?
  • Does having naloxone during an overdose mean that people won’t call 911?
  • Any bad outcomes after using naloxone?  Naloxone has a shorter half-life than opioid drugs- has anyone ever re-overdosed after the Narcan wore off?  If yes, what happened?
  • Anyone who used naloxone or had it used on them by a lay person may want to mention if it was nasally administered or injected.
  • If you are a provider/prevention/public health organization, Has it changed your service delivery?  How much training is necessary? 
  • If the price or availability of naloxone has been a concern, please mention this!
Personal experience is powerful if you are comfortable sharing

If you submit comments, please advise Eliza Wheeler (wheeler [at] and Alice Bell (abell [at] of your submission.

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