US Senate passes FDA Modernisation Act 

The US Senate passed the FDA Modernisation Act 2.0, S.5002, without dissent, taking a major step towards enacting a policy that could dramatically reduce testing on dogs, primates and other animals in the years ahead. The bill, introduced by Senators Rand Paul, R-Ky. and Cory Booker, D-N.J, with 10 other co-sponsors, will eliminate a federal mandate for animal testing for new drugs.

The bill also includes language from an additional proposed reform, the Reducing Animal Testing Act, authored by Senator Ben Ray Lujan, D-NM, to amend the Public Health Service Act to remove the animal testing requirement for biosimilars. S. 5002 mirrors provisions of the original FDA Modernisation Act provision approved as an amendment to an FDA legislative package taken up in June by the Senate Health, Education, Labour and Pensions (HELP) Committee.

“Leaders of the Senate from both parties recognise that the US must lift an archaic animal-testing mandate for drug development and replace that strategy with 21st-century methods grounded on human biology. This is the biggest policy development in Congressional history on the fight to replace animal testing with morally and scientifically superior methods,” said Wayne Pacelle, President, Animal Wellness Action and the Center for a Humane Economy.

Animal Wellness Action, the Center for a Humane Economy, and nearly 200 organisations, medical associations, biotech and patient advocacy groups applaud Senate passage and call on the House to take up the measure. Senators Paul and Booker introduced their original bill, S. 2952, last October. They modelled their bill after the House version of the FDA Modernisation Act, H.R. 2565, introduced by Representatives Vern Buchanan, R-Fla., and Elaine Luria, R-Virg., and has broad bipartisan support. The US House of Representatives passed its FDA legislative package for user-fee reauthorisation in a landslide vote of 392 – 28 in early June after the committee passed the measure 55 – 0. That package included the FDA Modernisation Act.

The legislation has the potential in the coming years to reduce the use of millions of animals and to deliver safer, more effective drugs to patients.

“The FDA Modernisation Act 2.0 will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science, and I’m proud to have led the charge with our fellow co-sponsors. The passage of this bipartisan bill is a step towards ending the needless suffering and death of animal test subjects – which I’m glad both Republicans and Democrats can agree needs to end,” said Dr Paul.

AWA and the CHE extended appreciation to Patty Murray, Chairperson, Senate HELP Committee, D-Wash., and Ranking Member Richard Burr, R-N.C., for their support of the measure. These lawmakers recognised that the FDA Modernisation Act had attracted broad bipartisan support in the Congress.

“We applaud so many lawmakers for taking action to move drug development into the 21st century and to allow for innovation that will bring much needed cures to Americans, said Gary Michelson, MD, Founder, Michelson Centre for Public Policy.”

“We are already on the verge of the next phase of modern drug development, and FDA modernisation will be the catalyst for this transition to modern science,” noted Tamara Drake, Director, Research and Regulatory Policy, Centre a Humane Economy.

Data show that it typically takes 10 to 15 years and an average investment of $1 billion and up to $6 billion for a new drug. Animal tests are non-predictive of the human response to drugs. This antiquated process of pharma innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals.