Lawmakers introduce FDA Modernization Act to save more beagles from experimentation
WASHINGTON (7News) — The 4,000 beagles now up for adoption, including those visiting Congressional staffers on Capitol Hill this month, were rescued from a breeding facility in Cumberland, Va.
The facility, which supplied dogs to research labs, is closing according to an announcement in June after multiple federal complaints and claims of animal welfare violations cited by the U.S. Department of Agriculture (USDA).
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An undercover investigation by PETA led to the release of the beagles. PETA along with Animal Wellness Action and The Center for Humane Economy want lawmakers on Capitol Hill to fund more alternative testing.
“It’s a dead end and it’s a stale paradigm that for the sake of the animals and for humans waiting for treatment, this needs to be changed right now and there are ways to do that," said Kathy Guillermo, Senior Vice President, Laboratory Investigations Department with PETA.
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The facility located in Virginia isn’t the only one breeding dogs for experiments. At least five other facilities across the United States are licensed with the USDA to breed thousands of dogs for research including more beagles.
7News reached out to all five locations but got no comment from any of the facilities.
One of those facilities is located in North Rose, New York. It's one of the largest ones in America that supplies dogs to research labs. Reports estimate that more than 20,000 dogs call this place home. We asked to take a look inside but didn’t get a response.
In 2019, out of the 797,546 animals used in research labs by the USDA, 58,511 dogs were used in experiments," the USDA reports .
Kansas leads the nation in dogs being used at research labs with a total of 9,759 dogs used in experiments followed by Massachusetts with 9,279 and Wisconsin with 5,692.
In the DMV, Maryland leads the way with 621 dogs.
A new bill in Congress called the FDA Modernization Act of 2022 is asking for a big change.
"Right now the animal testing industry is more than 11 billion dollars around the World where there are about a billion dollars being invested in these non-animal testing but I think that would change greatly if we can get this FDA Modernization Act done," says Thomas Poole, D.V.M., M.P.H., Senior Veterinarian with Animal Wellness Action & The Center for a Humane Economy.
The bill won’t ban animal testing, but it will eliminate the requirement for animal testing, allowing the Food and Drug Administration (FDA) to grant private companies the opportunity to use non-animal testing methods for new drugs.
READ MORE | U.S. House of Representatives 2565 - FDA Modernization Act
READ |U.S. Senate 2952 - FDA Modernization Act
Currently, new drugs by law have to first undergo animal testing before hitting the market. It's been that way since 1938 after the passing of the Federal Food, Drug, and Cosmetic Act.
The FDA and the USDA would not answer 7News' questions on camera but the FDA did send an email:
1. Why do beagles make good partners in completing research for new drugs?
Animal research has played an important role in advancements such as preventing polio, eradicating smallpox, and identifying new cancer treatments. Animal research today continues this important role in enabling medical progress for these diseases and other medical conditions. For example, animal studies contributed in important ways to the expedited development of treatments and vaccinations for COVID-19. While FDA often advises the regulated industry on approaches that may be taken to address the scientific, regulatory, and statutory considerations to obtain marketing approval for a proposed drug product, the regulated industry is ultimately responsible for designing, conducting, analyzing, and then submitting to the FDA, scientific studies (i.e., humans, animals and in vitro) to support a demonstration that a proposed drug is safe and effective for the intended use. The FDA recognizes the importance of selecting an appropriate model for a particular exploration relevant to public health. Often an appropriate animal model is capable of imitating or predicting a particular physiological or pathologic mechanism of interest to investigate. Sometimes the best model for a study is a purpose-bred dog model, particularly beagles, due to their controlled genetic predictability, pharmacological bioavailability of certain drugs, smaller size, and tractable nature.
While the FDA is committed to doing all that it can to replace, reduce, and/or refine animal-based studies (often referred to as the “3Rs”) in the broad context of human and animal drug development, there are still many areas where animal research is scientifically necessary because the current state of science does not support replacement of all animal studies with non-animal methods. Current non-animal methods cannot always predict effects that occur in highly complex interacting systems (such as the human body), to include information on treatment timing, clinical signs, intervention, and length of treatment, just to name a few variables. Additional research is scientifically necessary before alternative methods can be used routinely for addressing such complex issues. It is also worth noting that without the use of animals, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering from many life-threatening diseases. We understand and share the concern that animals involved in research should only be used when necessary. When these studies are scientifically necessary, the animals involved in research should be cared for under strictly enforced, humane guidelines and laws.
As one example of our commitment to the “3Rs,” FDA announced in November 2018 that it was taking steps to propose a study that, once completed, could provide a way for animal drug developers to conduct certain types of research without the use of dogs. To help meet that aim, a minimally-invasive, non-terminal beagle study currently under way is designed to validate a research model for the comparison of blood levels of certain orally-administered canine drugs, in order to provide an alternative approach that animal drug developers can use to generate data needed to support the FDA’s approval of these types of drugs without the use of dogs during the research process. At the conclusion of the study, the dogs will be retired for adoption as pets. (For more information, see https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-efforts-reduce-animal-testing-through-study-aimed.)
The FDA has already taken additional significant steps to reaffirm and strengthen our commitment to the “3Rs”and support the development and use of alternative methods (such as assays and technologies like organs-on-a-chip). We’ve formed the Modeling and Simulation Working Group to accelerate the adoption of modeling and simulation tools in product development and evaluation; initiated the Toxicology Working Group,which has developed a roadmap for integrating emerging predictive toxicology methods and new technologies into regulatory safety and risk assessments; and initiated the Alternative Methods Working Group (Advancing Alternative Methods) to support the advancement of new technologies as alternatives to animal testing. FDA’s Center for Drug Evaluation and Research (CDER) has recently published a review of its efforts to support the 3Rs in carrying out its health mission mandate. The FDA also participates in theInteragency Coordinating Committee on the Validation of Alternative Methods.
Most recently, the June 2022 meeting of the Science Board to the Food and Drug Administration included a discussion of the Agency's enhanced efforts to spur the development, qualification, and adoption of new alternative methods for regulatory use that may replace, reduce, and refine animal testing and have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness.
2. What are the possible benefits and disadvantages for the FDA if the Modernization Act passes?
The FDA does not comment on proposed or pending legislation.
The Americans for Medical Progress (AMP), which supports animal testing, points out some alternative testing is already being done.
“Is the AMP opposed to the use of non-animal testing methods?" asked 7News Investigative Reporter Scott Taylor.
“No, not at all. We applaud the advancement of non-animal alternatives however we also need to recognize that these are relatively new technologies and they are in their infancy which means they only answer a fraction of the questions we are asking about safety in medications," said Jim Newman with Americans for Medical Progress.
Dr. Thomas Hartung is at the forefront of what the FDA Modernization Act wants more of at the Center for Alternative Testing in Baltimore, Md. He said alternative testing involving stem-cell technology and bioengineering research is the future.
“These allow us to study really what the human brain does. We are not seventy kilograms rats. It is really important for us to have models that are human to understand what chemicals do for Autism, Alzheimer's disease and others," added Dr. Thomas Hartung, Director of The Center for Alternative Testing.
The AMP believes research using animals is still very valuable.
“It's an incredibly important issue. Making sure our medication is safe. Developing new medications to treat cancers, muscular dystrophy, and countless diseases. All of that requires studies of animals and people need to understand that," said Newman.
7News couldn't track down anyone who was against reducing the number of animals used in experiments but how fast those numbers can be reduced will be up for debate until people in Congress do something about it.
Supporters of the FDA Modernization Act point out that it has a great deal of bipartisan support in Congress and it has a good chance that it will be attached to a must-pass spending bill that will keep the government running through mid-November.
If it isn't attached to a spending bill, look for it to be re-introduced as its own stand-alone bill in the near future.
