Fda Modernization Act

Floor Speech

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Mr. PAUL. Mr. President, I rise today to talk about a bill that would lift a mandate in the law dating back to the Great Depression. This mandate is that drugs have to be tested on animals before clinical trials in humans.

This law was created back in the thirties--but I think makes no sense today--when the only methods we had back then were animal trials or human trials. But as the cofounder of a leading bioconvergence startup wrote in ``Forbes'' last December:

[T]his legislation was passed 20 years before the first modern blood tests, 40 years before [the] modern computers and 60 years before the human genome was mapped. Now, we have all these tools and so many more to evaluate and ensure the safety of cosmetics and drug candidates before they reach human trials.

The problem is, the law never caught up to the science. The law perversely requires drug developers to test on animals, which often means killing them after the test is over, even when nonanimal methods would work better. Passing this bill will put a stop to the needless suffering and death of millions of animals in labs across the country.

An emeritus neurology professor at Mayo Clinic, David Wiebers, wrote earlier this month in the Kansas City Star that the--

[D]ifferences in genetics and physiology among species can change the way a drug is metabolized in the body. As a result, the predictive value of using animals for toxicity testing is far from optimal. The intent of the 1938 requirement for animal models was to keep toxic drugs from harming patients.

A noble quest.

Yet, statistics show that these animal tests are flawed and misclassify many toxic compounds as safe.

This partly explains why over 90 percent of drugs found to be safe in animal testing end up failing in human clinical trials. But animal tests can be more than twice as expensive--sometimes up to 30 times more expensive--as nonanimal alternatives. This is despite the fact that it takes over a decade to bring a new drug to market and costs about a billion dollars.

You would think that if you are making that kind of investment, you would be getting something for your money. But not when the government gets in the way of progress.

It is often said that the definition of insanity is doing the same thing over and over again and expecting a different result. We have mandated animal testing for the last 84 years, and it meant slower approval for promising drugs and cures.

The time has come for the law to finally catch up with the science. I am glad the Senate has acted, and I hope the House of Representatives will now move quickly to pass this measure into law.

This law will allow the option of not doing animal testing. It is not that it will forbid and prevent any animal testing; it simply will allow the option of bringing drugs to market without sacrificing animals if we don't need to.

5002, which is at the desk.
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