Jerry C Rosenberg - Comment

One cannot doubt that the FDA serves an essential role in protecting the people of the Unied States from unintended commercial misadventures as well as outright fraudulent practices. We support and endorse their goals and congratulate them for all the good they do. But it is inevitable that their judgement is not infallible, as this draft guidline indicates. It purports to protect but its true effect will do more harm than good. We need to be able to carry out unfettered research. That will result in the data that will allow the FDA. as well as the health care porfession. to make reasoned fact-based ddecisions. I support the FDA, but i do not support this guideline: I strongly oppose it.