Chair Rodgers Statement on FDA’s Lab Developed Test Rule

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) issued the following statement regarding the Food and Drug Administration’s (FDA) recently-announced proposed rule to regulate laboratory developed tests (LDTs):

“This rule goes well beyond any of the proposed LDT legislation and will stifle innovation of diagnostics, such as those used to detect rare diseases. By adding new costly regulations, patients could lose access to diagnostics that identify potentially fatal conditions. Any LDT policy should go through the legislative process with deliberative consideration by the committees of jurisdiction. In order to strike the appropriate balance between adequate protections of public health and facilitating innovation, the FDA should rescind this rule and allow Congress—the people’s voice—to consider the matter.”