Animal Welfare and FDA

A coalition of animal rights organizations has filed a lawsuit to force FDA to address issues about animal testing that were raised in its 2007 citizen petition (FDA Law Blog, www.fdalawblog.net). The animal rights organizations want FDA to mandate that companies consider non-animal tests before using animals. This is apparently the standard in the EU.

It would be nice if FDA answered their citizen petition. A "no" with explanation is all that is required. And FDA Matters believes that "no" is the right answer.

FDA now encourages the use of alternative, non-animal tests for pre-clinical safety, but most drug and biologic applications rely heavily on animal data. But what's the big deal? Is "mandating consideration of alternative tests by sponsors" really much different from "encouraging sponsors to use non-animal alternatives?"

According to the animal rights organizations, the new language would reduce or eliminate "ineffective and costly animal testing methods that fail to identify the dangerous and lethal effects of drugs and devices on humans, and yet needlessly inflict pain and suffering on millions of animals each year."  And therein, their real agenda is revealed. They want to discredit animal research in order to force use of alternative tests. You can hear them shouting: get rid of animal testing, even if it means an increased risk to humans.

Thankfully, FDA doesn't see it that way. Along with other government agencies and industry, it is working on the development, validations, and utilization of alternatives to animal testing. But this is hard work and progress does not appear to be rapid. Meantime, unlike the activists, FDA believes that animal testing provides critical information that could not be gotten any other way.

In an earlier column, I wrote that animal research and testing is one of FDA's (unacknowledged) core values. Using animals to gain insight is a 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.

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.

There are elaborate arguments about whether animals should have rights or just have their welfare protected. 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.

In the face of animal rights activism, FDA seems willing to stand its ground. The FDA stakeholder community needs to "seize the day" and make clear where its stands. Those who benefit from animal research and testing (including consumers and patients) need to provide the manpower and financial resources to counter the animal rights movement in America and its threat to medical progress for humans.

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

Steven

The link to the FDA Law Blog article on the lawsuit is: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/04/fda-sued-by-animal-rights-advocates-and-ear-holistic-candle-advocates.html

My earlier column that relates to this topic:

Animal Research: One of FDA's Core Values

November 5th, 2009

Earlier this year, ABC's Nightline did a story about alleged abuses at the nation's largest primate research center. Fueled by this, the Great Ape Protection Act (HR 1326) now has 95 co-sponsors, compared to 29 sponsors on a similar bill in the last Congress.

The bill would virtually eliminate research using chimpanzees, even where there is no other animal model that could serve to predict safety in humans. This is a threat to animal research and, ultimately, to ourselves. The loss of chimpanzees would be a serious blow to research and would encourage animal rights activists to push for even more restrictions. Read the rest of this entry »