In general, the industry could not exist without regulation - patent protection, PDUFA clock, FDA “seal of approval,” and on and on.

I would suggest that it is more likely, after objectively crunching numbers, that safety surveillance - inside and outside companies - has _added_ to innovation.

I would also suggest smart companies know that.

Safety must be the major part of product development! For example: We could easily design a car that would get 150mpg if we made the body panels out of paper. Would you drive one?
So let’s drop the pesky requirements for safety and emphasize the requirement for buyer be ware. What wonderful innovation we will see.
Personally I hope and pray that any drug/device company that feels the way you do does move offshore and/or goes out of business. The sooner the better.

http://www.gooznews.com/archives/000975.html
states: “a treatment registry to track clinical outcomes for patients with difficult to treat diseases. . .would bring the doctor and patient back into the knowledge acquisition process … something very threatening to the narrow interests of drug companies . . .and their sponsored physician experts/Key Opinion Leaders who shape clinical practice and clinical research.

This is an alternative to the current adverse events reporting system which, to my mind, is one of the critical areas at FDA that is dysfunctional. Clinical trials–generally designed by drug manufacturers to prove efficacy–should not be the only metric for drug approval. A clinical registry where MDs could quickly note adverse events–and without FDA’s voluminous requirements for follow-up–would permit safety issues to be addressed in a TIMELY manner. Instead, the current FDA system seems to rely on the accumulation of ‘dead bodies’–when the pile of dead bodies is high enough, alarms sound and investigations proceed. (Not much help for those in the pile!)

Getting rid of cronyism, and seeking out experts to run the agency who place mission above politics would be a start for repairing this current sad excuse for an agency tasked with protecting the public. There ARE smart, talented, creative experts ‘out there’ . . . hopefully a new administration will ferret them out and start to repair this damaged agency.

FDA Science Board Advisory Committee Meeting
Table of Contents – (Edited to show only the statements on the conditions of the FDA)
Major Findings………..3
1.2.1 The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak………3
1.2.2 The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability………….4
1.2.3 The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate…………………………..5
2.1 Growing Disparity between Responsibilities and Resources…..9
3.1 Science: Capability, Capacity and Organization….20
3.1.1 Finding: FDA does not have the capacity to ensure the safety of food for the nation…21
3.1.2 Finding: The development of medical products based on “new science” cannot be adequately regulated by the FDA….24
3.1.3 Finding: There is insufficient capacity in modeling, risk assessment and analysis….30
3.1.4 Finding: The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization…….33
3.2 Workforce: Securing Critical Scientific Capability and Capacity38
3.2.1 Finding: The FDA has substantial recruitment and retention challenges…..40
3.2.2 Finding: The FDA has an inadequate and ineffective program for scientist performance…….42
3.2.3 Finding: The FDA has inadequate funding for professional development……….42
3.2.4 Finding: The FDA has not taken sufficient advantage of external and internal collaborations……….43
3.3 Information Infrastructure……..45
3.3.1 Finding: The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain……46
3.3.2 Finding: The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate…………47
3.3.3 Finding: The FDA cannot provide the information infrastructure support to regulate products based on new science…….49
3.3.4 Finding: The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services……50
3.3.5 Finding: The IT workforce is insufficient and suboptimally organized……..51

I also recognize there are often (usually?) ambiguities surrounding getting clear answers to any of them. But, while the quesitons may be difficult to answer, they are not impossible.

I believe there are cases in which is is clear companies _did_ know (post-marketing), covered and camflaged, and went out of their way to continue to do so. There are also many cases when they did not. The former are the situations that I think about when I think about “drug safety.”

I agree with Laurie , I don’t buy it either Nathan…
If this was the case then why do situations like this happen?..

http://seroxatsecrets.wordpress.com/2008/02/26/glaxosmithkline-the-game-is-up/

I would buy that if we didn’t have new information coming out daily on the misrepresentation of initial clinical trial data. That is where the mistrust is coming from. Pharma can’t continue to claim “we didn’t know about the problem until it went market wide” when the data disputes that claim.
Yes, drugs have side effects and alot don’t become an issue until they are given to “real, unscreened” patients. But the fact that we are seeing that the problems were there and undiclosed is a BIG problem.

The legislative (or judicial) pursuit of risk free drugs will result in the death of pharmaceutical innovation. Period.