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FDA Thumbing Its Nose at Congress
On Implementing the FDA Modernization Act
U.S. Senators, in a letter, reminded the FDA Commissioner of his duty to apply new
federal law in drug development and embrace 21st-century human-based biological tests
By Tamara Drake, Zaher Nahle, and Wayne Pacelle
“FDA’s regulations related to animal testing no longer fully conform to applicable law,” wrote five Republicans and four Democrats in the U.S. Senate in a letter to FDA Commissioner Robert Califf. The letter, led by Senators Rand Paul, R-Ky., and Cory Booker, D-N.J., demands an explanation from the FDA on its failure to initiate the writing of new agency regulations in the wake of Congress passing the landmark FDA Modernization Act, now nearly a year ago. Other signatories, also serving on the Senate committee with oversight of the FDA, are Mike Braun, R-Ind., Ben Ray Lujan, D-N.M., Roger Marshall, R-Kansas, Angus King, I-Me., John Kennedy, R-La., Tim Kaine, D-Va., and Eric Schmitt, R-Mo.
The FDA’s failures to act cannot be explained by opposition from the scientific community to the FDA Modernization Act. Indeed, biotech companies and drug developers supported the law and, by every measure, are hungering for innovation and regulatory changes in drug screening, after operating under an archaic 84-year-old statute that mandated animal testing for all preclinical drug testing. More than 350 global publications, including news articles, commentaries, scientific reviews, and primary papers, have been published since the signing of the FDAMA into law in December 2022. Overwhelmingly, these publications underscore the significant value of the new law in advancing drug development and shifting the existing paradigm towards 21st century human-biology-based technologies and applications.
The FDA Modernization Act, spearheaded by the Center for a Humane Economy [[link removed]] and Animal Wellness Action [[link removed]] along with the Michelson Center for Public Policy, PETA, and a very broad coalition of patient-rights advocates, biotech companies, and others key stakeholders, amended the Federal Food, Drug and Cosmetics Act, allowing sponsors of new drugs to include new technologies and human-relevant testing methods (e.g., AI, organoids, organ chip) in lieu of animal experiments.
Mounds of laboratory data reveal that animals, from mice to dogs to primates, have proved to be poor predictors of therapeutic response in humans. That means that the animal-testing mandate has been catastrophically bad in forecasting the human reaction to experimental drugs, with a documented 90-95 percent failure rate. The cost of repeated failures in preclinical testing has delayed drugs getting to market, impeded the development of preventions and cures for millions of patients in life-and-death moments, and driven up drug prices to make them unaffordable for many Americans.
Congress determined that the FDA and the nation can do better and prescribed a legislative cure of its own: the FDA Modernization Act 2.0, led by Senators Paul and Booker and Representatives Vern Buchanan, R-Fla., Rep. Buddy Carter, R-Ga., and Rep. Tony Cardenas, D-Calif., along with two Members no longer serving in the House, Elaine Luria, D-Va., and Kurt Schrader, D-Ore.
FDA Has Been a Long-Running Barrier to Change
But even as the scientific community was underscoring the value of the new law, the slow-to-move, stubborn-minded FDA was downplaying its enactment. And that’s been more of the same from the FDA, which has long signaled to drug developers that extensive animal testing is required for all preclinical drug screening, but at the same time would contradict itself by declaring that there was no legal requirement for animal testing. The effect of this tangled thinking was to obligate drug sponsors to use animals for preclinical screening trials but to confuse Congress, patient advocacy groups, and other key stakeholders from breaking this animal-testing mindset and mandate. It’s been a long-running ‘soft mutiny’ over attempts to modernize the efforts of the agency and to accept new, better, life-saving science.
The long-running claims by the FDA that animal testing wasn’t mandated by law were shown to be false in 2020 in a key case on the subject before a federal court. In Vanda Pharmaceuticals v. FDA , when a U.S. District Court judge found [[link removed]] that “FDA is not free, legally speaking, to simply allow drug sponsors to proceed with human trials without adequate animal studies.” The fog had been cleared, and the Center for a Humane Economy went to Congress and said it was time to act. A bipartisan group of lawmakers paid heed, and in unanimous actions in the House and Senate, the animal testing mandate was lifted when President Biden signed the legislation.
Now President Biden must work with his agency on this matter and give clear instructions to the obstructionists in the bowels of the bureaucracy to stand down. Indeed, President Biden shouldn’t face resistance at the helm of the agency, since FDA Commissioner Robert Califf, as Senator Paul and other lawmakers noted in their recent letter, testified in the Senate and “spoke favorably about the shift toward human-based biology, noting that alternative methods may include cell-based assays, organ chips and micro-physiological systems, computer modeling, bioprinting, and a growing variety of other New Approach Methodologies (NAMs).”
This isn’t complicated. It’s basic civics: Congress passes law, agency implements law. We don’t need a day’s more delay after decades of reliance on an archaic, counterproductive animal-testing mandate. That long-standing policy denied life-saving treatments to patients, delayed the delivery of the limited set of drugs with health-promoting qualities, put drug prices beyond the reach of millions of Americans, and put more than a million animals a year on the chopping block, including tens of thousands of primates (endangered primates often smuggled from jungles in Asia among them) and even larger numbers of beagles and other dogs.
FDA’s Archaic Regulations Need Rehaul with Enactment of FDA Modernization Act
In its popular section labeled “Drug Review Steps Simplified,” the FDA highlights to information seekers the “preclinical (animal) experiments” as a first step in its review process. The instructions assertively direct sponsors that they “must test new drugs on animals for toxicity.” Directives go on to explain that “Multiple species are used to gather basic information on the safety and efficacy of the compound being investigated/researched.”
To facilitate progress, the Center for a Humane Economy and Animal Wellness Action have identified and curated nearly 50 similar areas of concern and noncompliance with the FDA Modernization Act in specific regulations at the FDA. These findings were shared [[link removed]] in earnest with agency leadership.
At this juncture, what is urgently needed from the agency is twofold:
1- FDA must initiate rulemaking and provide regulatory clarity so that existing regulations comport with the FDAMA and Congressional intent.
It is a basic function of an executive agency to conduct rulemaking after a meaningful and pertinent change in federal law, especially so when existing regulations are obsolete and at odds with Congress’s intent.
2- FDA must undertake a serious effort to qualify nonanimal test methods for regulatory use in drug development.
FDA programs that qualify, evaluate, and accept nonanimal test methods are cursory, ineffective, and lack transparency, failing to modernize the process or encourage drug developers to adopt alternative methods. Of grave concern is the misguided yet growing narrative adopted at the FDA that the construction of animal-chips - and other animal-derived tools—are good first steps to understand human biology. Such a detour will not only decelerate progress but move the entire FDA Modernization process on the issue of human relevancy in drug development backwards.
The use of human relevant models must be the basis of any paradigm for preclinically studying serious diseases to forecast the safety and efficacy of experimental drugs for human use. That must be complemented by a crystal-clear, accountable, and transparent regulatory process, including at a minimum the full and speedy implementation of the policy mandates enacted by the FDAMA statute a year ago.
Earlier in his term, President Biden called for a “moon shot” on cancer. He and the rest of the executive branch must understand that overreliance on non-predictive animal tests are slowing down cures and treatments for cancer and hundreds of other diseases. The era of early 20th-century science, relying on virtually useless animal tests, must now give way to the new science of human-based biology and its faster, more reliable means of screening drugs.
Tamara Drake is director of research and regulatory affairs at the Center for a Humane Economy. Zaher Nahle PhD, MPA is the senior scientific advisor [[link removed]] for Center for a Humane Economy. He earned his MPA from Harvard University and his PhD in Physiology & Biophysics from the Stony Brook. He is a Dean's Scholar at Johns Hopkins Carey Business School. Wayne Pacelle is president of Animal Wellness Action and the Center for a Humane Economy.
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