Biopharma sees tougher FDA approval process
The Wall Street Journal offers more bleak assessments from the pharma industry on their ability to win an FDA approval for a new therapy. Schering-Plough has already shuttered two programs it once held high hopes for and it may soon axe a third. Delays on prasugrel and Cordaptive are adding to the uncertainty and tomorrow an FDA panel will ponder tougher approval standards for diabetes drugs.
"What will it take to get new drugs approved?" Schering-Plough CEO Fred Hassan asks. "The point is, we don't know."
The WSJ notes that it's getting tougher to win an FDA approval even as the number of NDAs is already scraping a 24-year low.
- read the report from the Wall Street Journal
ALSO: Developers say FDA may force higher costs, more time for diabetes programs. Article
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Comments
It is time for the healthcare industry to tackle growing health problems realted to lifestyle, like diabetes and obesity, upstream at the source instead of marketing dubious fixes in the form of medications. Healthcare professionals and regulators know that polluting the body with chemicals to cure disease caused by lifestyle factors related to poor diet and lack of exercise, is a losing battle for patients. The only winners are corporate interests selling junk food, a physically inactive (automobile-centric) lifestyle, and pharmaceutical companies selling the "cure". The Republicans running the government and pharmaceutical companies have had nearly a decade to strip the FDA of resources and promote short sighted interests that have lead to a sick population and a sick planet. It's time for more insightful leadership to emerge and solve problems instead of feeding into the existing misery.
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