Senate Passes FDA Bill with Sen. Paul Reform Language Included
Clause will expedite FDA access to and application of data from analogous overseas trials for life-saving drugs
WASHINGTON, D.C. - Today the U.S. Senate voted to pass the Food and Drug Administration Safety and Innovation Act (S.3187), which included language inserted by Sen. Rand Paul. This language would force the FDA to accept data from clinical investigations conducted outside the United States, including the European Union, to speed the process of getting life-saving drugs on the market by the FDA.
"Innovation in clinical drug trials should not be confined to the data received from trials in the United States. Findings from countries that incorporate the same rigorous requirements as we do when developing life-saving drugs and devices should be accepted by the FDA as well," Sen. Paul said. "I am proud to see this important step being taken to increase the treatment options of millions of Americans currently hampered by outdated laws."
Sen. Paul also introduced an amendment yesterday to the bill that would curb the Food and Drug Administration's overreach and abuse of power. Sen. Paul's amendment, No. 2143, would disarm the FDA, toughen up the mens rea component of many prohibited acts under the Food, Drug and Cosmetic Act in an attempt to end armed raids on natural food stores and Amish farmers, and stop FDA censorship of truthful claims of dietary supplements. It failed passage by a vote of 78-15.