"FDA scientists I have encountered do care deeply about patients and want to say "yes" to safe and effective new therapies. Regulatory approval is the only bridge between miracles in the laboratory and lifesaving treatments. Yet until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, their duty is to stop it—and stop it they will."
"Congress has an opportunity to improve all this as it considers renewing FDA user-fee legislation this year. The temptation will be to reauthorize the fees as quickly as possible and move on as usual for another five years. This would be a grave mistake. Reforms that allow the FDA to say "yes" to innovative therapies serve all the agency's stakeholders, including current and future patients. "
"Otherwise we had better get used to the agency saying no by calling "time out" or, worse, "game over" for American companies developing new, vital technologies like regenerative medicine."
It appears to me that he justifies the dismally slow work done by the FDA to their pathetic ignorance for lack of funds. And threatens that it will get slower and slower till it stops unless they get more funds. He threatened us like a union normally does, with a work stoppage. My solution is to transform the FDA to handle their business like private companies and corporations. Fire non-producers, those that cannot meet their schedules, since he implied they do not know of what they do. Such bs. And folks like Scher and Hussain and Pazdur should be fired immediately for lack of production and unethical (criminal) ties to outside influences. Hire young and smart doctors that are fresh and eager and equipped with up-to-date science. Promote them. Weed out the non-productive who do not produce. Fire those who make large mistakes. For starters, fire the top two management layers immediately.
Folks learn on the job, OJT. Always have and always will. Folks should work hard and dig to understand their task. Some may work extra hours or take work home to meet deadlines. Folks do NOT have to attend conferences to learn how to do their job. The COMPUTER AGE practically eliminated such redundant travel and leg work. It made learning much easier and faster and increased productivity by light years. Von Eschenbach believes the rest of us live in the stone age. Screw his lame excuses and threats of a work strike. Fire those folks like Reagan did with the FAA folks. Oh, and forget about the idea of hiring others to do the job that the current people cannot do. Total BS. This guy reminds me of Kelly Martin.