The U.S. government has signed into law the elimination of a 84-year-old law that required any new drugs up for approval before the FDA to be first tested on animals.
The mandate which had been in place since 1938 forced any FDA approval to be first contingent on animal testing. The revamping of the drug approval process has led supporters to tout this new law as promising a dramatic reduction in the use of dogs, primates, and other animals in laboratory tests.
“This is the biggest policy development in Congressional history in the quest to replace animal testing with morally and scientifically superior non-animal methods,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “Lawmakers were persuaded by our campaign to scrap mandatory animal testing in favor of 21st-century testing methods grounded on human biology.”
More than 200 organizations, medical associations, biotech, and patient advocacy groups backed the legislation. Pacelle also paid tribute to Laurie McGrath of the McGrath Family Foundation of San Diego and the late Robert “Skip” Trimble of Dallas for helping drive the effort at crucial stages to modernize drug testing in the United States.
The omnibus spending bill also includes $5 million in new money to support an FDA-wide New Alternative Methods Program to reduce animal testing. That funding came as a derivative of lobbying campaign to pass the FDA Modernization Act 2.0.
The Senate and the House had independently approved the FDA Modernization Act in the preceding months. In September, Senators Rand Paul, R-Ky., and Cory Booker, D-N.J., won the unanimous support of their colleagues in passing S. 5002 as a stand-alone measure. S. 5002 also included Senator Ben Ray Lujan’s Reducing Animal Testing Act.
The U.S. House passed its FDA legislative package in June by a vote of 392-28. That measure, H.R. 7667, included the original version of the FDA Modernization Act, introduced in April 2021 as H.R. 2565 by Reps Vern Buchanan, R-Fla., and Elaine Luria, D-Virg. Other original cosponsors of H.R. 2565 were Reps. Mikie Sherrill, D-N.J., Nancy Mace, R-S.C., and Brendan Boyle D-Pa.
“The FDA Modernization Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge with our fellow cosponsors. The passage of this bipartisan bill is a step toward ending the needless suffering and death of animal test subjects – which I’m glad both Republicans and Democrats can agree needs to end,” said Senator Paul, M.D.
“Thanks to modern scientific innovation, the use of animal toxicity testing for experimental drugs has become increasingly obsolete,” said Senator Cory Booker. “This legislation will eliminate unnecessary suffering for countless animals when scientifically reliable alternative testing methods are available.”
Senator Booker led a successful Congressional effort in 2016 to require the use of alternative methods where available for assessing risks posed by chemicals, under the Toxic Substances Control Act.
Data show that it typically takes 10 to 15 years and an average investment of $1 billion and up to $6 billion to develop a new drug.
Moreover, animal tests are not reliable predictors of the human response to drugs. In addition to sacrificing millions of animals, this antiquated process of drug screening, dictated by the Federal Food, Drug and Cosmetics Act of 1938, slows delivery of palliatives and cures for patients, drives up drug costs, makes it prohibitively expensive for drug developers to explore medical solutions for rare diseases, and sacrifices countless animals.
The progress of the FDA Modernization Act in the United States has stirred scientists in Spain, the Netherlands, Switzerland, the United Kingdom, India, and other countries to revamp their drug development standards and ground them on human biology.
In practical terms, pharmaceutical companies conduct research and marketing across many countries and achieving regulatory harmonization allows them to conduct their business more seamlessly.
“It’s a win-win for people, animals and industry, and it has the potential reduce drug costs and ease the pain for Americans during an era where inflation has driven up the average American family’s living costs,” said Marty Irby, executive director at Animal Wellness Action.