Re: FDA Process Redesign
Reference Talon, Nidan, Look, Tred Posts with links (Thanks!)
Based on what appears to be a much more inclusive approach of getting drugs to specialists in their areas of expertise along with, patient support groups, and research organizations, I’d say that the FDA has done some self scrutiny and ironed out some of its wrinkles (no doubt there are hints of mea culpas in there, Nidan, as you suggest.)
“One goal is to engage sponsors earlier in the development process to ensure that trial designs are efficient and structured in the most effective way to identify risks and measure benefit. Equally important, there will also be more ability to engage external stakeholders, such as disease specialists, academic researchers and regulatory partners at other agencies. And with patient-focused drug development becoming a reality, ongoing relationships and interactions with patient groups are becoming an important part of our regulatory practices. “
From Talon’s post - thanks.
This seems to me as though the FDA has given up its historical “Rule by Divine Right” and stopped issuing “edicts” and “Papal decrees” to approve new medicines and trials, which were outside its scope of knowledge, and decided to practice more “focus group medical treatment approvals”, since, after all, the industry will yield its greatest benefit to date by gathering and considering the input of all stakeholders involved.
One must ask if this is in part due to the high, HIGH, degree of criticism this agency has come under for past poor performance and now, not just wanting to get it right, but, also, to have others share in the blame/success.
The products which have been approved, as Xena has often pointed out, have been found in many cases to be disastrous to your health, and the result of political impropriety/connections. Shame on that practice, from start to finish, and however it was allowed to grow and fester.
Perhaps, between the lawsuit commercials...if you or a loved one has taken xyz and experienced any of the following..., and the disclaimers at the end of every drug commercial...ask you doctor..., along with the congressional hearings on drug price gouging and the financial burden this has posed to the entire healthcare system, the FDA has decided to no longer be the scapegoat?
I know this doesn’t seem like the most noble motives to ascribe to their new approach, but it could be playing a part in the realistic motive. Or at least one? If the FDA cleans up its act by spreading the responsibility for trials among more entities with something to gain: patients, caregivers, doctors, research and funding organizations, perhaps, in the end, the fault will not lie on the doorstep of the FDA solely and, of course, best case scenario, better/quicker/less expensive/more effective/safer medicine will be the result.
It’s a shame it took so many years of blemished record and total chaos about the safety and efficacy of everything approved on the market, along with scandals like the Rumsfeld - aspartame disgrace (criminal!) to bring change about. This is anything but proactive, but it is here, at last. And at a time when BP has given up the ghost on big CNS drugs, and precision medicine methodology can be embraced. This bodes extremely well for AVXL / no matter what the impetus for change, pure or not so?
Thanks to all the excellent watchdogs on this board. In your debt - all. Keep up the good work - we may be viewed as crusaders when history is written. No greater honor.
With gratitude,
Biostock
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