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The historic measure to reduce the use of animals in research was approved by Congress

PoliticsThe historic measure to reduce the use of animals in research was approved by Congress

The FDA Modernization Act 2.0, which would significantly reduce the use of dogs, primates, and other animals in laboratory tests, was approved by the U.S. House of Representatives on December 23. The provision, which is part of an end-of-year budget measure that President Biden will sign later that day, eliminates a need for new FDA-approved drugs to undergo animal testing for the first time since 1938. The Reducing Animal Testing Act, which is included in the Food and Drug Administration Modernization Act, would do away with the need for animal testing for biosimilars in the United States.

According to Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy, “this is the most important policy reform in the history of Congress in the drive to replace animal testing with morally and scientifically superior non-animal alternatives.” We were successful in persuading lawmakers to replace mandatory animal testing with 21st century testing methods based on human biology, thanks to our campaign.

Over two hundred healthcare, patient, and industry organisations came out in favour of the measure. Mr. Pacelle also paid tribute to Robert “Skip” Trimble of Dallas and the late Laurie McGrath of the McGrath Family Foundation in San Diego for their roles in the development and implementation of innovative drug testing methods in the United States.

The $5 million increase in funding for the FDA’s New Alternative Methods Program to phase out animal testing is another component of the omnibus spending bill. The FDA Modernization Act 2.0 was passed with the help of this money from lobbyists.

During the preceding months, the FDA Modernization Act was passed independently by the Senate and the House. During the month of September, S. 5002, sponsored by Rand Paul (R-Kentucky) and Cory Booker (D-New Jersey), was approved as a stand-alone measure with 100% support from the Senate. Senator Ben Ray Lujan’s Reducing Animal Testing Act (S. 5002) was included as well.

The FDA legislative package was passed by the House of Representatives 392 to 28 in June. The first draught of the FDA Modernization Act was included in H.R. 7667, which was first introduced as H.R. 2565 in April 2021 by Representatives Vern Buchanan (R-Fla.) and Elaine Luria (D-Va.).

“I’m proud to have been a leader in getting the FDA Modernization Act 2.0 passed with the support of my colleagues in the Senate and House of Representatives because it will reduce unnecessary bureaucracy and hasten the introduction of new, more effective drugs.

Senator Cory Booker has said that the use of animals in toxicity tests for new pharmaceuticals is becoming irrelevant as a result of scientific progress. By prohibiting the use of animals in experiments where there are more humane alternatives, this rule will save many creatures from pain and suffering. In 2016, Senator Booker led a successful legislative effort to require the adoption of alternative methodologies when available when assessing the threats posed by chemicals under the Toxic Substances Control Act.

It may cost anything from $1 billion to $6 billion and take anywhere from 10 to 15 years to create a new drug. What’s more, the response of humans to drugs cannot be predicted by experimentation on animals. The Federal Food, Drug, and Cosmetics Act of 1938 requires an inefficient method of drug screening that involves the unnecessary suffering of millions of animals, increases the expense of drugs, and discourages researchers from pursuing treatments for uncommon illnesses.

Additionally, Senators Mike Braun (R-Indiana) and John Kennedy (R-Louisiana) were named as early cosponsors of the FDA Modernization Act by Animal Wellness Action. Members of Congress like Senator Patty Murray (D-Wash.) and Representative Richard Burr (R-N.C.), as well as Representatives Frank Pallone (D-N.J.) and Ranking Member Cathy McMorris Rodgers (R-Wash.), and Health Subcommittee Chairwoman Anna Eshoo (D-Calif.) and Ranking Member Brett Guthrie (R-Ky.), all played important roles. Likewise, the leadership of Representatives Buddy Carter (R-Georgia), Kurt Schrader (D-Oregon), and Tony Cardenas (D-California) on the House Committee on Energy and Commerce is commended.

Scientists in Spain, the Netherlands, Switzerland, the United Kingdom, and India, among others, have been encouraged by the progress of the FDA Modernization Act in the United States to revise their drug development criteria and make them more in line with human biology. Because pharmaceutical companies conduct research and promote their products in many different countries, regulatory harmonisation is essential for their smooth operation.

“It’s a win-win for people, animals, and industry,” said Marty Irby, executive director of Animal Wellness Action and one of The Hill’s Top Lobbyists for 2019-2021. “It has the potential to reduce drug costs and ease the pain for Americans in an era when inflation has increased the average American family’s living costs.”

According to People for the Ethical Treatment of Animals’ Laboratory Investigations Department vice president Kathy Guillermo, “The FDA Modernization Act opens the door to better research and speedier medication development, and it has the potential to relieve millions of animals from pain and death.” “PETA is grateful to the tens of thousands of supporters who took action, and to the legislators who recognised that testing novel medicines on animals is less accurate than tossing a coin,” the organisation said.

“The moment has arrived for the United States to stop using animals for research purposes. The director of Programs at SPCA International, Lori Kalef, referred to the FDA Modernization Act 2.0 as a “monumental victory” that will hasten a change that has been desperately needed for a long time.

Shannon Keith, Esq., president and inventor of the Beagle Freedom Project, said that the FDA Modernization Act was a “logical step” toward a more ethical society in which all beings are treated with respect and dignity and the door is opened to compassionate research.

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