Hereâ€™s how it begins:
"A cautious FDA sweating product safety issues and going slow on new approvals. An election year in which healthcare tops the agenda. Increased oversight, increasingly demanding payors and ever more aggressive generic competition.
Throw in some gloomy global market trends, and 2008 promises to be a tough one for a pharmaceutical industry trying to dig its way out from under a mountain of looming patent expirations on key products. If 2007 was a year of disappointmentâ€”with hotly anticipated products like torcetrapib, rimonabant and Galvus failing to make it to market and safety jitters hitting others, like Avandia, Zelnorm and Exuberaâ€” 2008 looks like more of the same. For all the talk about acquisitions, big pharma firms sitting on large cash piles might look to Pfizer's inability to translate scale into lasting dominance and think twiceâ€”if there were even anything attractive left to buy. And the trickle of really innovative new products coming down the pipe will have to vault high hurdles to make the grade at the FDA, with Rep. Henry Waxman breathing down Andrew von Eschenbach's neck."
And hereâ€™s the conclusion:
"At least one FDA watcher is more sanguine. â€œIn a political year, the FDA is going to understand that it needs to be apolitical,â€ says Peter Pitts, director of the Center for Medicine in the Public Interest. â€œFDA is in the business of protecting and advancing public health. It's not an agency that wants to deal with politics at all, but it's been buffeted by very potent political winds from the outside.â€
The Reagan-Udall Foundation established by the FDA Amendments Act will, together with the FDA's Critical Path Initiative, revolutionize drug development, says Pitts. â€œBy streamlining and improving the science of drug regulation, we can bring drugs to market more rapidly and safely by helping companies fail faster, so that they can reinvest those resources in more successful propositions,â€ says Pitts. â€œUltimately, Critical Path is like a game of Chutes and Ladders, helping companies avoid the chutes and scale the ladders.â€
Here's a link to the complete piece:
And be sure to check out the predictions of the six health care cognoscenti interviewed for the story.