{"database": "press", "table": "releases", "rows": [["https://www.booker.senate.gov/news/press/booker-schmitt-paul-king-braun-whitehouse-kennedy-lujan-blumenthal-introduce-the-fda-modernization-act-30", "Booker, Schmitt, Paul, King, Braun, Whitehouse, Kennedy, Luj\u00e1n, Blumenthal Introduce the FDA Modernization Act 3.0", "2024-09-15", "2024", "2024-09", "Democrat", "Senate", "NJ", "Cory A. Booker", "B001288", "www.booker.senate.gov", "booker", "https://www.booker.senate.gov/news/press", "scraper", "WASHINGTON, D.C. \u2013 Today, U.S. Senators Cory Booker (D-NJ), Eric Schmitt (R-MO), Rand Paul (R-KY), Angus King (I-ME), Mike Braun (R-IN), Sheldon Whitehouse (D-RI), John Kennedy (R-LA), Ben Ray Luj\u00e1n (D-NM), and Richard Blumenthal (D-CT) introduced the FDA Modernization Act 3.0, a bipartisan bill to direct the FDA to finally implement the FDA Modernization Act 2.0 (FDAMA 2.0), legislation passed by Congress to modernize drug testing protocols and improve patient outcomes.\n\nIn 2022, FDAMA 2.0 was signed into law by President Biden. This law removed the longstanding requirement under the Federal Food, Drug, and Cosmetic Act (FDCA) that investigational new drugs (INDs) undergo mandatory animal testing before human clinical trials. Instead, the law allowed drug developers to use advanced, non-animal methods such as cell-based assays, organ chips, computer modeling, and bioprinting.\n\nDespite the passage of nearly two years since FDAMA 2.0 was enacted into law, the FDA has yet to update its regulations to conform with the law, leaving numerous FDA regulations that continue to call for animal testing. The FDA Modernization Act 3.0 seeks to resolve this by mandating the FDA to update its regulations within six months of the bill's enactment. It also includes a technical correction to the statute by addressing a duplicated section heading.\n\n\u201cThe FDA Modernization Act 2.0 was a landmark achievement for both animals and public health, paving the way for 21st century human-relevant science,\u201d said Senator Booker. \u201cIt\u2019s time our country takes full advantage of technologies that can more accurately predict human responses and accelerate our nation\u2019s drug development. This bipartisan legislation will ensure the FDA finally aligns its regulations with the law.\u201d\n\n\u201cThe FDA Modernization Act is aimed to do exactly what the Bill is named to do \u2013 modernize our FDA and remove overbearing and often unnecessary animal testing requirements on new drugs. I\u2019m proud to join Senator Cory Booker on this important bipartisan legislation,\u201d said Senator Eric Schmitt.\n\n\u201cIn 2022 I was proud to lead the charge on the FDA Modernization Act 2.0, which was a critical step in reforming our drug approval process\u2014getting life-saving treatments to patients faster, cutting costs, and embracing non-animal testing methods. Now, with FDA Modernization Act 3.0, it\u2019s time to build on that success and ensure reforms can proceed expeditiously. Swift passage of this legislation will continue breaking down unnecessary barriers, so Americans can access safe, effective drugs without delays and at reduced costs,\" said Dr. Rand Paul.\n\n\u201cThe FDA Modernization Act 2.0 was designed to be a win for patients and animals alike, but it can only do so if the FDA makes the changes the law required \u201c said Senator King. \u201cIn the 21st century, access to cutting-edge technology allows drug developers the option to use modern animal-free testing methods in nonclinical tests where appropriate. However, it\u2019s been nearly two years since this bill was signed into law and we have yet to see the updated regulations and reforms put in place. I\u2019m grateful to my colleagues for their work on the FDA Modernization Act 3.0 to ensure the agency fulfills the aims of our earlier legislation.\u201d\n\n\u201cThe FDA Modernization Act was an important bill for protecting animals from drug testing. This bill is needed to get the FDA to update its regulations to follow the reforms put in place by our original legislation,\u201d said Senator Mike Braun\n\n\u201cIt\u2019s been nearly two years since President Biden signed the landmark FDA Modernization Act 2.0, yet the FDA continues to stall and delay the law\u2019s implementation. I\u2019m glad to support Senator Booker\u2019s bipartisan effort to push the FDA to move away from outdated animal testing to more modern drug development methods,\u201d said Senator Whitehouse.\n\nThe FDA Modernization Act 3.0 is a bipartisan effort to reduce unnecessary animal testing while advancing scientific innovation. By fully implementing FDAMA 2.0, drug development can be both more humane and more efficient, ultimately leading to faster and more reliable treatments for patients. An astonishing 90-95% of drugs that pass animal tests go on to fail in human clinical trials, wasting precious time for patients.", 1, "2026-03-30T01:40:41Z", "2026-04-07T21:43:57Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://www.booker.senate.gov/news/press/booker-schmitt-paul-king-braun-whitehouse-kennedy-lujan-blumenthal-introduce-the-fda-modernization-act-30"], "units": {}, "query_ms": 2.5900080800056458, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}