WASHINGTON, Sept. 29, 2022 /PRNewswire/ -- In an exciting development, the U.S. Senate unanimously passed the FDA Modernization Act 2.0, S.5002, a bill that was reintroduced yesterday by Senators Rand Paul, R-Ky., and Cory Booker, D-N.J., who co-sponsored the original bill (S.2952). This comes a day after the committee on Health, Education, Labor, and Pensions (HELP) reached an agreement regarding the Food and Drug Administration Safety and Landmark Advancements Act of 2022 or FDASLA (S.4348) but that stripped all attached riders, including the FDA Modernization Act of 2021. In swift reaction, Senators Booker and Paul reintroduced the FDA Modernization Act 2.0, S.5002 separately for consideration by the Senate today.
To this end, the FDA Modernization Act 2.0 (related bills, S.2952/H.R.2565) amends the outmoded regulatory guidance at the FDA by broadening the options for drug developers seeking regulatory approvals to include modern and human-relevant testing methods, in lieu of less effective animal experimentation. In doing so, the FDA Modernization Act introduces much-needed improvement to the process of drug development. Such a change is expected to speed up the discovery process and lower the cost of life-saving medicine.
Of note, the existing drug development paradigm, established by statute in 1938 under the Federal Food, Drug, and Cosmetics Act (FFDCA), requires animal tests to be conducted in all new drug applications submitted for regulatory approvals, even though 90—95% of drugs that pass animal testing fail when tried in humans.
A growing number of stakeholders have voiced their support for the FDA Modernization Act. These include influencers from the biotech industry, nonprofits, and academia. For instance, open letters were sent from biotech industry leaders and the the Jane Goodall Institute and Vivodyne to the HELP committee in charge of negotiating the FDASLA in the Senate. That is in addition to the public support to the FDA Modernization Act from entities such as the BICO group and Emulate, Inc, committed to promoting 21st century alternative methods to animal testing.
Importantly, the passage of FDA Modernization Act in both the House and Senate is required for the advancement of this important bill to the next step in the legislative process. With this new development in the Senate, the path is now open for the inclusion of the FDA Modernization Act 2.0 in this year's Congress Conference report, a summary of agreements on legislation negotiated between the House and Senate. In turn, such progress would pave the way for the FDA Modernization Act 2.0 to be approved by the executive branch, ultimately enabling this legislation to become an enforceable law, possibly this year.
"This welcomed development is excellent news for scientific innovation and a key step forward towards making the FDA Modernization Act 2.0 the law of the land – which would facilitate developing safer and more efficacious drugs, faster and with reduced cost," said Dr. Zaher Nahle, Chief Science Officer at the Center for Contemporary Sciences (CCS). "It is essential that we double our efforts now to reduce any barriers that might come up next in the legislative process and continue to advance legislations that bolster disruptive medical technologies."
CCS continues to support the work of the Senate committee on Health, Education, Labor, and Pensions (HELP) and the House Energy and Commerce committee as they enact policies to promote healthcare innovation and human-relevant testing.
About Center for Contemporary Sciences
Center for Contemporary Sciences (CCS) is pioneering a paradigm shift towards innovative, evidence-based research methods that are based on human biology. We champion technologies that are better for humans and that replace animal testing.
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SOURCE Center for Contemporary Sciences