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Good Science

May 2017


 

Did you know our federal government has a permanent committee that works to evaluate and promote alternatives to animal testing?

Congress established the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in 2000 to promote acceptance of alternative safety tests that protect human health and the environment.

Alternative means the approach either refines procedures to lessen animal pain or distress, reduces the number of animals used in a particular test, or replaces animals with tests that don’t use animals, such as cells, tissues, or predictive computer models.

On May 23, ICCVAM held its annual public forum. Representatives from 16 member agencies, including the Environmental Protection Agency, the Food and Drug Administration, and the National Institutes of Health shared updates on progress and plans.

Elizabeth Baker, Esq., (right) with the NICEATM deputy director, who coordinates ICCVAM, at NIH
Elizabeth Baker, Esq., (right) with the NICEATM deputy director, who coordinates ICCVAM, at NIH

One of the most exciting updates was the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods’ (NICEATM) presentation of a new national roadmap to modernize chemical and medical product testing by replacing and reducing animal testing. This roadmap is compelling because all of the ICCVAM member agencies agreed on its vision, mission, and goals. The EPA discussed progress it is making on a pilot project to move away from acute toxicity test requirements for pesticide formulations, or final products, and the availability of scientifically valid replacement approaches for assessing skin allergy for global use. Finally, the Department of Defense, the National Center for Advancing Translational Science, and the Food and Drug Administration are conducting a scientific evaluation of tissue/organ chips that would replace animals for pharmaceutical, food safety, and other testing.

The Physicians Committee works with federal agencies and other stakeholders toward the common goal of replacing traditional animal tests with more accurate approaches that are based on human biology. During the presentations, three ICCVAM speakers publicly thanked the Physicians Committee for hosting workshops, providing expert resources, and establishing training opportunities on modern alternative approaches.

The Physicians Committee’s senior science policy specialist, Elizabeth Baker, Esq., provided a comment on ICCVAM-related activities to complement a written comment we submitted in advance of the meeting. In the comment, we commended good work from some member agencies and called upon others to do more to advance alternatives.

The next opportunity for public comment and engagement with ICCVAM is on Sept. 18-19 at the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting. At this meeting, we will offer advice that supports use of alternative, human-focused approaches to better protect patients, the environment and animals.

May 11, 2017   other

 

It happens more often than it should: Patients experience serious or even fatal complications during clinical trials for not-yet-approved medicines. But complications can also happen after the Food and Drug Administration (FDA) approves the drug and it is sold to patients.

Drugs should be tested using human biology-based methods such as tissue chips and modeling approaches to give us a better sense of how humans will react to the treatment. Animal tests simply can’t ensure safe medicines, but the FDA still requires animal tests for all new medicines.

A study published this week confirms the scope of the problem. Doctors found that 32 percent of FDA-approved medicines from 2000 to 2010 were “affected by a postmarket safety event.” This means they were either withdrawn, required black box warnings, or led to FDA safety communications after patients began taking them.

The study raises concern about how well medical products are tested, particularly given recent pressure on the FDA to speed up the approval process. One way to speed the approval of safer treatments is to accept modern tests that are based on human biology.

The Physicians Committee is working to make testing faster and more human-relevant. We support the development of new approaches and train regulators how to use them. Additionally, we are working with lawmakers and leading patient safety groups to change FDA regulations and National Institutes of Health funding practices. These science, policy, and educational advances will help safeguard patients by giving the FDA better information before approval decisions are made.

Want to learn more? Check out this episode of The Exam Room to hear our experts discuss medical safety: