Orrin Hatch: “the second amendment we are considering, No. 1183, will encourage the prompt and complete reporting of potentially vital…”

“the second amendment we are considering, No. 1183, will encourage the prompt and complete reporting of potentially vital public health information to the FDA. Essentially, my proposal codifies a rule that already applies to drugs and medical devices and makes it applicable to all FDA-regulated products. Specifically, my amendment would codify the liability disclaimer provisions that appear at 21 CFR section 803.16, for devices; 21 CFR section 314.80(l), for new drugs; and, 21 CFR 312.32(e), for investigational new drugs. My amendment is closely patterned after these three provisions of existing regulation. The public health benefit and rationale for my amendment are simple: A rule that encourages reporting to the FDA of any alleged adverse incident now and resolving liability issues later, helps the FDA achieve its public health mission. The FDA is a public health agency, not an arbiter of tort liability. That is the job of the courts. But what is important for the public health is that FDA be able to receive quickly and completely raw data pertaining to adverse experiences with products under its regulatory purview. Please understand that my amendment, like the existing regulations, is tort neutral. Nothing in my amendment, or in the existing regulations, increases or decreases an ultimate finding of liability.”