Monday, October 10, 2011
Regulation watch
I offer without comment -- you think I'm stupid? -- a widely-circulated op-ed by Scott Gottlieb, former deputy commissioner of the United States Food and Drug Administration. Nut graffs:
This is an all too familiar story, the FDA impeding useful innovations in the U.S. Entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. When clinical studies get started, the FDA is asking for longer and larger trials that increasingly mirror hurdles proposed for new drugs.
In response, American device makers are moving their business overseas. Between 2004 and 2010, more than half of all innovative devices were first approved in Europe. Because more devices now launch in Europe, companies increasingly study the products there. In 2004, 86.9% of all medical-device studies listed in www.clinicaltrials.gov were being carried out in the U.S. By 2009, only 45% of clinical trials were run here.
RTWT.
5 Comments:
By 
Marv, at
Tue Oct 11, 04:31:00 AM:
Another one of the many American self inflicted wounds. Trial lawyers, for example, often do more harm than good in the aggregate when it comes to their utility in serving society. Similarly, America has destroyed her economy with her ever increasing dependence on foreign energy while she sits on vast reserves of her own.
The simple reality is that there is nothing that is perfect. While it is laudable to seek perfection in areas such as safety, it is clear that excessive caution can lead to deaths as well. What America needs is a government that knows how to make the right choices. These are choices that balance excessive caution with careless haste. In both cases, people die. It's time to admit this and allow the professional regulators the freedom to weigh the balance without special interest group interference.
America had such tremendous wealth and technological advantage on the world that it could afford the conceit of unreasonable regulation but the costs of a burdensome bureaucracy are now coming into account. It's ironic that the previously more regulated and socialistic societies of Europe are now moving ahead of the USA.
It's death by a thousand cuts.
By 
, at
Tue Oct 11, 09:11:00 AM:
One of my children has been invited to attend a small Q and A with Rick Perry after the New Hampshire debate at Dartmouth. Do you have any suggested questions on this subject (or other subjects) for her or her friends to ask? I will forward them and, if asked and answered, I will try to learn his response and relay it back here.
By , at
Tue Oct 11, 02:25:00 PM:
Question for Perry:
My son is in college and would make a great surgeon, I believe. There's sure to be a need for more doctors. But on current trajectory -- including where personal tax rates are going -- it makes no sense for him to put in the time, money and effort. What would you tell him?
By , at
Tue Oct 11, 02:26:00 PM:
By , at
Thu Oct 13, 04:00:00 PM:
Sorry to report Governor Perry cut the Q&A rather short. My daughter was unable to ask him any questions at all, unhappily. She enjoyed the experience but wishes she had a chance to ask questions of Herman Cain.
