US Senator Ted Cruz wants to change the way the Food and Drug Administration approves drugs. Indeed, the introduction of his “Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act” has sparked hot debate, says Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter.
In this draft legislation, Sen Cruz proposes that Congress should be allowed to overrule the FDA if a potentially life-saving drug is rejected, and also that drugs already approved in certain developed countries, such as Japan, Canada, Australia and Israel, should be approved on a reciprocal basis.
Sen Cruz wants the FDA to be given thirty days to evaluate evidence in favor of a drug approved elsewhere in the world. Should it decide against reciprocal approval, then Congress will have the power to overturn this decision by a majority vote.
What implications will this legislation, if approved, have for the FDA’s ability to ensure that medications are safe and effective?