Tuesday, August 27, 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.

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.

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.


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