Dear Senator,

I urge you to cosponsor the FDA Modernization Act, (S. 2952) and support the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (S. 4348), which includes the provisions of the FDA Modernization Act. The House passed their version of the FDA Modernization Act (H.R. 2565) with a vote of 392 to 28 as a rider to H.R. 7667, the Food and Drug Amendments of 2022.  

The FDA Modernization Act amends the Federal Food, Drug and Cosmetics Act (FFDCA) of 1938 to allow the FDA to authorize the use of 21st-Century science to determine the safety and efficacy of new drugs. Our current drug development system is badly broken. The FDA Modernization Act repairs some of the damage and puts health care and animal welfare on better footing in America.

The bipartisan bill favors the best test methods, whether animal or non-animal methods. If enacted, it will lower drug costs, speed delivery of drugs to patients, reduce the number of animals used in science, and increase the safety and effectiveness of drugs and vaccines. 

Under the current regulatory scheme:

•    American consumers are faced with extraordinarily high costs for drugs, inordinately long wait periods in bringing the drugs to market, and, even after the drugs are approved for common use, serious health side effects for consumers often result from taking the drugs.

•    95 percent of drugs found safe in nonclinical tests fail during human clinical trials due to toxicities not predicted by traditional animal tests or because of lack of efficacy, in large part, because animal data are not predictive of the human response.

•    Adverse drug reactions are the fourth highest cause of death in the U.S.

Updates to the FFDCA would provide drug sponsors more options for testing the safety and efficacy of drugs to improve clinical trial attrition rates, cut time to market in half, and substantially reduce R & D costs which could cut drug prices fivefold.

We can apply human biology-based test methods to better predict how humans will respond to drugs in clinical trials. We are already on the verge of the next phase of modern drug development and allowing for the use of only animal models doesn't reflect 21st Century scientific advancement.  The FDA Modernization Act will be a catalyst for this transition to modern science.

It's time for FDA to update its ossified, decades-old regulations and requirements for animal tests and to allow for nonclinical test models that are predictive of what will happen in humans in clinical trials. It's just good science and common sense. It's time for FDA to trust the science.

Sincerely,