FDA Modernization Act

The FDA has outdated rules that require testing on animals even when animals don't get the disease that humans are trying to cure. In fact, as many as 95 percent of drugs that make it through animal tests fail when they go to clinical trials. We can't afford to stick with this outdated, dangerous, slow, and expensive drug development model.

The FDA Modernization Act of 2021 (H.R. 2565 and S. 2952) would eliminate that requirement and enable scientists to use the best scientific methods available.

The FDA has outdated rules that require testing on animals even when animals don't get the disease that humans are trying to cure. In fact, as many as 95 percent of drugs that make it through animal tests fail when they go to clinical trials. We can't afford to stick with this outdated, dangerous, slow, and expensive drug development model.

The FDA Modernization Act of 2021 (H.R. 2565 and S. 2952) would eliminate that requirement and enable scientists to use the best scientific methods available.

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Subject:

I am a concerned constituent in your district and urge your support for H.R. 2565 (Rep. Vern Buchanan, Rep. Elaine Luria), and S. 2952 (Sen. Rand Paul and Sen. Cory Booker), The FDA Modernization Act. The FDA Modernization Act is included as a rider in H.R. 7667, the Food and Drug Amendments of 2022, which passed the House 392 to 28.  The Senate HELP committee also recently passed its version of the package (FDASLA – S.4348) and that legislation package also includes the FDA Modernization Act.

Now Senator Richard Burr of North Carolina has introduced legislation to strip all riders from the bill, leaving just the base funding package for FDA.  That maneuver will block key reforms of FDA and keep the status quo when it comes to animal testing.  Animal testing for new drugs is the biggest driver of the use of animals in testing, resulting in the use of tens of thousands of beagles and primates and hundreds of thousands of other animals. These tests are not only inhumane, but they typically are not predictive of the human response to drugs, with the animal-testing mandate producing a morally and scientifically broken drug development paradigm.

If enacted into law, this important legislation would remove the mandate on animal testing. We now know that animal testing is not an effective measure of whether a drug is dangerous to humans. In fact, research from the National Center for Advancing Translational Sciences has found that more than 95% of drugs that pass animal testing fail in human trials for either being ineffective or unsafe.

Removing the animal testing mandate would open the door for emerging, superior testing methods based on human biology that a growing number of scientists are pushing for—from cell-based assays and organ chips to microphysiological systems and sophisticated computer modeling. These new advancements are the quickest, safest, most cost-effective solutions to developing accurate treatments for human disease—making the need to test on animals obsolete.

More than 115 million animals are used each year in biomedical research. These dogs, cats, primates, rabbits, mice, and other animals used in testing are no different than our own family companion animals. Americans do not want their tax dollars funding research with little scientific value that causes extreme, needless suffering to these animals.

I urge you, please cosponsor and support the FDA Modernization Act and keep the FDA Modernization Act rider in any final legislative package that provides funding to the Food and Drug Administration. This legislation would not only save billions of animal lives, it would bring our pharmaceutical regulation into the 21st century, enabling us to create safer products faster and ensure the US remains a competitive place to develop new drugs. This law would proudly set a new gold standard for research ethics and animal welfare.

Please vote for The FDA Modernization Act. Lives are literally depending on it.

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