January 15, 2010 – PZP Distribution & Planning

In yesterday’s post, I touched on why, how, and where PZP is made. Today I would like to briefly discuss what is involved with the status, distribution, and use of PZP.

PZP’s status as a vaccine is often misunderstood. For example, it is often described as “not being FDA-approved” and an “experimental drug.” These descriptions are a little misleading as they are referring to stages in the Food and Drug Administration’s process and not necessarily the nature of PZP itself. The FDA allows PZP to be used on wildlife (i.e. wild horses and deer) under Investigational New Animal Drug (INAD) exemptions. To have an INAD exemption from the FDA, a substance must have evidence demonstrating its safety. Due to the extensive research that has been done on PZP, this is not a problem. The Humane Society of the United States (HSUS) holds INAD 8857, which concerns the use of PZP on wildlife. Because PZP is used under an INAD exemption, its use must always be framed around a research objective that is approved by HSUS. Thus, it is acceptable to describe PZP as experimental in the sense that it is under an INAD exemption which requires certain protocols to be followed. It is not acceptable to describe PZP as experimental in the sense that people are still trying to figure out how it works. Being FDA-approved is a last step in the process that allows for a substance to be commercially marketed. Recall that the people behind PZP have no interest in making profit. Because of this, there is no reason for them to go through the costly process of obtaining FDA approval. It should be noted that this will all soon change as the FDA is turning wildlife contraception projects to the Environmental Protection Agency.

For now, though, let’s focus on how it works now and has been working in past years. Let’s set up a hypothetical situation: There is a herd management area, and the BLM managers there have decided they want to use PZP to manage the herd. These managers will need to develop a management plan that essentially describes how and why PZP will be used. This plan is submitted to HSUS, and they review the plan and will make the final decision on whether or not it is suitable. They ensure that the plan will be effective in managing the wild horses and also that it will not be effective in totally eliminating the wild horses. Because the wild horses are on a herd management area, using PZP also requires that the BLM managers go through the NEPA process by developing an Environmental Assessment. This is just like they would do if they were planning to have a gather where horses were to be removed. We’ll talk more about these documents when we look at different herds where PZP is used. Once this planning process is completed, the BLM will be authorized by the HSUS to obtain enough PZP to carry out their planned action. It is important to remember that HSUS controls PZP; this is again because they hold the INAD exemptions. Thus, the BLM, or anyone else, cannot do anything with PZP unless HSUS has authorized it.

The regulatory and planning processes that PZP is involved in are complex. I have learned about them largely through conversations with people like Drs. Patricia Fazio and Allen Rutberg. I have just touched on major points in this post; but with an understanding of these points, I think it will next be best to explain how PZP is actually administered to wild horses. This is a very important topic we will cover tomorrow.

Published in: on January 15, 2010 at 5:00 pm  Comments (2)  

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2 CommentsLeave a comment

  1. Very very interesting explanation of the process for approval of PZP for use in managing wild horse herds. I would be interested in any references to why the approval process is being transferred to EPA. I would think that Department of Interior would be a more logical choice, unless the idea is to create checks and balances against BLM use for herd management (?)

    • I am not sure why FDA is transferring the wildlife contraception programs to EPA. Maybe EPA’s a better fit for them. It’s not just PZP, it’s all wildlife contraception. I understand that the zoo contraception programs will stay with FDA, though; and PZP is often used in zoos. A useful publication on this was written mainly in regards to GonaCon, which is a different immunocontraceptive that works again GnRH instead of the zona pellucida. Still, though, it’s got some good information about the regulatory process and the changes that are occurring. This paper is Wildlife Contraceptives: A Regulatory Hot Potato by John D. Eisemann, Kathleen A. Fagerstone, and Jeanette R. O’Hare . It can be found by clicking here.

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