Monday, August 26, 2013

Update on S. 959 and Vet Compounding

Back in July we wrote about a proposal coming before the U.S. Senate that, if passed, threatened to ban pharmacies from compounding medications prescribed by veterinarians to treat dogs, cats, and horses.

We examined why this would be so detrimental to family pets, and Dr. Sara Huber explained how
compounding medications might sometimes be the only way a veterinarian can accurately dose small breeds, puppies and kittens.

(click here to read more)

Now we'd like to update you on the status of that legislation, and if it still poses a threat to the medical care of our family pets.

snapshot of Amy's letter from Senator Roberts
A fellow blogger - Amy of Sebastian the Sensitive Soul -  has a pharmaceutical background and was particularly concerned about this.

So she decided to write her senator and let him know she opposed anything that would ban veterinarians from offering compounded medicines to family pets.

Senator Pat Roberts wrote her back and assured her that he has long been an advocate for local
pharmacies and referenced a "significant amount of misinformation" that was circulating about the proposed legislation.


Here is a direct quote from his response to her (used with permission):

"S. 959 makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the Food and Drug Administration. This legislation clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation." (emphasis mine)

Hey, that all sounds pretty good to me. It is ethical and moral to ensure the safety of compounded medications, especially after the 2012 meningitis scare where tainted pharmaceuticals from a compounding manufacturer in Framingham, MA resulted in illness to over 700 people

But please note what he did not mention. Not once did he address her concerns with regard to animals and veterinarian-prescribed medications. I wanted to know why, so I dug deeper. 

So, are animals addressed 
in this legislation or not?

After hours of poring over the actual wording of the legislation itself, including strikethroughs from previous iterations of the proposed bill, I've found out a few things:

One: on May 22 this legislation, known as S. 959, was passed by the Senate Health, Education, Labor and Pensions (HELP) Committee. It currently awaits consideration on the floor of the U.S. Senate.

Two: anyone who is brave enough, has the time, or is suffering from insomnia can read the progress of this proposed bill for themselves, online at a website called GovTrack.us. It includes previous wording as well as the final wording the HELP Committee passed on to the Senate floor.

Three: oh yes, animals are mentioned quite a bit in the wording of this bill, 41 times in fact. And it's interesting to note that they're almost exclusively in the parts of the proposed legislation that have been deleted.

Will pharmacies like this one continue to have the freedom
to compound prescriptions for our pets?
The organization that brought this to our attention, My Meds Matter, expressed a concern that big drug
companies were trying to add an unrelated amendment to this bill that would forbid veterinarians from writing compound prescriptions for family pets.

They urged people to write their congressmen and ask that these provisions be removed from S. 959.

I'd count this a win - it appears they were successful.

I have signed up to follow the progress of this legislation via email updates from the Gov Track web site. It will be interesting to see how the wording changes once it passes from the Senate to the House of representatives.

Currently, 39 of the 41 references to animals have been removed from the proposed legislation.
Here are the two that are left:

Reference #1:
In the definitions section of the bill, a "DISPENSER" is defined as a retail pharmacy, etc, etc... and "does not include a person who dispenses only products to be used in animals."

In most cities, this exclusion is meaningless, as most veterinarians use human compounding pharmacies to fill their prescriptions.

Reference #2:
"Not later than November 1, 2016, the Comptroller General of the United States shall conduct a study and submit to Congress a report on the safety of animal drug compounding and the availability of safe and effective drugs for animals." [S. 959, section 102 (d)]

This second one is worth keeping an eye on, for if it's true that big pharma is trying to eliminate a veterinarian's ability to compound drugs for family pets, here might be their next opportunity to try to restrict that.  

Whew! This was one of our more difficult posts to wade through, both from a writing and reading standpoint, we know!

Thanks for hanging with us because, although it's not exactly a fun blog post, we think it's an important one.

(We promise to balance it out with a terrific 'Toon Tuesday tomorrow, and an awesome Wordless Wednesday!)

gratuitous shot of Maxwell and his baby blues



16 comments:

  1. Thank you so much for the update...I have found this whole thing very disconcerting and certainly hope that together we can make a difference. (Thank you too for slogging through all that crazy government-speak!)

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  2. I have been wondering what was going on with this. You know, I really think that it is up to constituents to keep track of bills they are interested in or that impact them because I get the feeling that a lot of times their representatives aren't aware of all the details in these bills, or understand their impact - but they DO listen to the people in their district. At least, OUR rep listens to us! Not so sure about anyone else's, MOL!

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  3. Thank you for wading through all of the mess one has to wade through to get to the heart of the matter. It is of utmost importance that this bill not include pharmacies that compound medicines for animals. THIS was a very important posting, Thank you so much for bringing this to our attention.

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  4. This is wonderful news! I received an early letter from my state senator that I wasn't too impressed with but haven't heard anything since then. Thanks to Amy for using her pharmacy background to get to the bottom of it!

    Gratuitous photos are always welcome.

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  5. Sounds pretty good to us! Your posts on compounding pharmacies piqued Mommy's curiosity...and she found a few compounding pharmacies locally (she was always under the impression it wasn't available here), one of which does it for vets.
    Here's a big THANK YOU for writing about this because now, if there's ever a need, Mommy knows where to go. :)

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  6. Thank you so much for wading through the language of the bill to figure out where it stood. We're relieved to hear that it sounds like better news for local compounding pharmacies than we had initially feared.

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  7. Thanks for the update! Seems like I had a similar response email like the one you posted here.

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  8. Mommy says, "thank you" for all your hard work in reading through all the government mumbo-jumbo and deciphering it for the rest of us. It does sound like good news for us kitties and all the other animals. Purrs and hugs, Lily Olivia, Mauricio, Misty May, Giulietta, Fiona, Astrid, Lisbeth and Calista Jo

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  9. Thanks for the update. It sounds like good news.

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  10. I too am glad to hear about this. I wrote as well and got a form letter back reminding me of the people who got sick from the compounded meds.. *shakes head* I do hope that someone actually read the letter.. but apparently it wasn't necessary. I'm glad there is some common sense in this bill.

    And thank you for the shot of Maxwell.. He made my heart smile and I needed that..

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  11. Thanks for your investigative repurrting! Disco is on 2 compounded medications and they make such a difference for so many pets!

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  12. Grrr, Blogger ate our comment in an error.

    Thanks for weeding through all this and sharing it.

    Have we told you how much we like the new look of your blog?

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  13. Thanks for taking the time to read all the details and share them with us. This is an impawtant matter!
    Purrs

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  14. Important post for sure, we hope they won't get away with banning the compounding for pets. Maxwell, thank you for your beautiful baby blues, you are so handsome.

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Coolio! A comment? For US?