Animal Research is an NIH issue, not the FDA. Or is it?

The value of animal research in the life sciences is considered an NIH issue. FDA Matters believes that FDA and its stakeholders should be equally involved.

Animal research is the vital first step in the development of new medical products. Before any safety or efficacy testing is permitted in humans, FDA must be satisfied with animal testing data submitted by the product sponsor. Pick any medical breakthrough and you will find animals were tested prior to humans.

For understandable reasons, we tend to focus on the human part of new products. Which patients will be helped and by how much? By the time a company files a New Drug Application (NDA) or the equivalent in biologics and devices, the headline is the human data. While the animal data is always relevant, it has largely served its purpose as the gateway for human trials.

We talk about the people part without recognizing that the pipeline of innovative drugs and devices would collapse if a broad range of research on animals (e.g. non-human primates, pigs, sheep, dogs, rats, mice, zebrafish, fruit flies, worms) was heavily restricted. Over 96% of the animals used in biomedical research are rodents, birds, fish and invertebrates. As background, there is an excellent summary on the need for animal research available from the advocacy organization, Americans for Medical Progress.

Everybody should be for protecting the welfare of animals. Any means to lessen our dependence on research animals should be welcome. Animals should always be treated ethically and pain reduced or eliminated. The fewest number of animals should be used to reach a conclusion that can be relied upon. Laboratories should be accredited and subject to inspection. Problems should be addressed within a facility under the watchful eye of government, accrediting and licensing agencies and in accordance with the Animal Welfare Act.

Since I last wrote on this topic two years ago, the nature of the animal rights movement in the United States has shifted. Successful prosecutions under the 2006 Animal Enterprise Terrorism Act (AETA) have purged some of the more violent elements of the movement and discouraged others from engaging in destructive acts. However, a small number of activists still use tactics of harassment, intimidation, and vandalism against some research scientists and veterinarians involved in working with laboratory animals.

Many of the research advocacy groups say a greater threat to medical progress is proposed state and federal legislation, often authored by animal rights lobbyists, that has little to do with animal welfare but rather seeks to restrict or raise the cost of animal-based research. An example is The Great Ape Protection and Cost Savings Act legislation, which continues to draw strong support in Congress. The House version (HR 1513) has 110 sponsors and the Senate version (S 810) has 11 sponsors.

These bills would virtually eliminate chimpanzee research, which includes work in vaccines, hepatitis, HIV, malaria/AIDS and some types of cancers. Although we use only a comparatively small number of chimpanzees in animal research, I am told that the work often provides essential information that cannot be obtained in any other way.

While the legislation is purportedly about animal welfare, these bills are really designed to limit the biomedical research that we all support and which, we hope, results in FDA-approved medical products.

For me, the choice is easy. I want a product or procedure tested in animals before it is given to me or my loved ones. I believe in protecting animals, but human rights come first.

The importance of animal research needs to be a core value for FDA. Those who benefit from animal research (including patients and industry) need to provide the manpower and financial resources to counter the animal rights movement in America and its threat to medical progress for humans.

republished and adapted with permission from FDAMatters, a weekly blog covering FDA policy and regulation