WASHINGTON, D.C. — U.S. Senator Angus King (I-ME) is introducing bipartisan legislation with eight of his colleagues to fast-track and modernize prescription drug testing protocols which will in turn improve patient outcomes. The FDA Modernization Act 3.0 (FDAMA) is a bipartisan effort to reduce ineffective animal testing and expedite scientific innovation. In 2022, President Biden signed FDAMA 2.0 into law removing the longstanding requirement that investigational new drugs (INDs) undergo mandatory animal testing before human clinical trials. Instead, the law provided FDA and drug developers the option to use advanced, non-animal methods such as cell-based assays, organ chips, computer modeling, and bioprinting. 

However, the FDA has yet to update its regulations leaving numerous FDA regulations that continue to require animal testing against the law. The FDA Modernization Act 3.0 seeks to resolve this by mandating the FDA to update its regulations within 12 months of the bill's enactment. 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. 

“Maine people deserve a modern FDA that approves prescription drugs in an efficient and safe manner consistent with the law,” said Senator King. “The FDA Modernization Act 3.0 will ensure that the American people have access to more reliable treatments, with renewed confidence in their governmental agencies that have long been bogged down with red tape and bureaucratic inefficiencies. I thank my colleagues on both sides of the aisle for prioritizing people over politics in Maine, and across the country.”

In addition to King, the legislation is cosponsored by Senators Cory Booker (D-NJ), Eric Schmitt (R-MO), Rand Paul (R-KY), Sheldon Whitehouse (D-RI), John Kennedy (R-LA), Richard Blumenthal (D-CT), Ben Ray Luján (D-NM), and Roger Marshall (R-KS).

Senator King has consistently worked to increase transparency of prescriptions drugs. Last year, he introduced bicameral legislation to prohibit direct-to-consumer drug advertising of pharmaceutical drugs in the first three years after the drug receives Federal Drug Administration (FDA) approval. Additionally, Senator King has introduced legislation to prohibit pharmaceutical drug manufacturers from claiming tax deductions for consumer advertising expenses.

To read the full text of the bill, click here.

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