In a move to revolutionize modern science in drug development, the U.S. Senate passed the FDA Modernization Act 2.0 (S.5002) in late September without a single dissenting voice. Now the U.S. House of Representatives must act before Congress adjourns for the year, sending the measure to the President to deliver treatments and cures to patients more quickly and at lower costs and sparing millions of animals in the process.   

Beagle FDA Modernization
Gentle beagles are among the hundreds of thousands of animals used each year in costly, ineffective drug tests.

 

 

 

 

 

 

 

 

S. 5002 bundles together two measures – the FDA Modernization Act and the Reducing Animal Testing Act, collectively eliminating archaic mandates for animal testing for all new drugs and biosimilars. This bill will end a Depression-era requirement for animal testing for every new drug being considered for the market. That requirement translates into the annual use of tens of thousands of dogs and primates and hundreds of thousands of other animals, even though the results of these tests demonstrate that animals do not reliably forecast the human reaction to drugs. 
 
It’s rare for all 100 Senators to agree on something.  The bill, conceived by Animal Wellness Action and the Center for a Humane Economy and led by Senators Rand Paul, R-Ky., and Cory Booker, D-N.J., is expected to revolutionize pre-clinical testing for drugs in industrialized nations since the FDA drug development standards are held up as a gold standard. The bill has the endorsement of nearly 200 organizations, medical associations, patient advocacy groups, and biotech companies. 
 
This bill must now pass the U.S. House, which already has signaled its broad support for modernizing drug testing strategies overseen by the FDA. The House antecedent to this bill, H.R. 2565, introduced by Reps. Buchanan and Luria, with nearly 100 cosponsors, was passed as part of a larger FDA reform measure in June with a vote of 392–28. Energy and Commerce Committee Chairman Pallone and Ranking Member McMorris Rodgers backed the measure. 

The bill lifts the animal-testing mandate established in the Federal Food, Drug and Cosmetics Act of 1938. By amending the law, Congress clears the way for the FDA to allow drug developers to use humane, human-relevant test methods, which in many cases, outperform animal tests.   

“This legislation was passed 20 years before the first modern blood tests, 40 years before 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,” said Senator Paul, an M.D., in his floor speech when he shepherded the measure to passage. 

Extensive—and Wasteful—Use of Animals 

There are 59,000 dogs used every year in lab experiments in the United States. Add to the toll about 68,000 primates used in these laboratory tests annually. And there are up to a million other animals used each year in labs. The amount of animal use is colossal in drug development, dwarfing the other categories of testing on animals, including cosmetics, chemical, or pesticide screening. Drug development isn’t done just by global pharmaceutical companies but also by hundreds of researchers at academic institutions and government agencies for their intramural work.  

The only pathway that will change this massive volume of animal use is passing the FDA Modernization Act 2.0. When the FDA accepts non-animal testing data, we’ll see an across-the-board reduction in the use of dogs, primates, rabbits, mice, and other creatures. 

Almost all major research organizations, pharmaceutical companies, academic institutions, and even government agencies have embraced the broadly accepted construct of the “3Rs” approach — Reduction, Refinement, and Replacement — to animal testing. The FDA Modernization Act 2.0 will test the companies to see if they make good on their public pledges. Where alternative methods exist, they have a moral and scientific duty to use them. 

Because animal testing is more costly, slower, and less reliable than alternative methods, the bill will have the effect of easing suffering and averting death for millions of people and nonhuman animals.   

Amending that Depression-era law offers the prospect of ushering in desperately needed cultural and scientific changes at the FDA. But Congress must complete work on the bill, and it’s up to the House to take up the measure for the health and wellness of people and animals. 

To help, contact your U.S. Representative today and urge him or her to cosponsor H.R. 2565 and to urge House leaders to make it a priority for the chamber to complete work on the FDA Modernization Act 2.0 this year.

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