The effort to restructure will take place in a context of public anxiety over drug safety. Perhaps the most worrying event
in the safety saga took place in October, when FDA issued an approvable letter for Bristol-Myers Squibb's Pargluva (muraglitazar),
calling for additional cardiac safety studies, and the company announced that it was considering withdrawing the drug from
"Here you have the best Type 2 diabetes drug ever produced, efficacy-wise," says Sander Flaum, managing partner of Flaum Partners.
"And now it's basically over with, because of the potential—potential—cardiotoxic effects."
"There hasn't been much discussion about balance," says Abbott CEO Miles White. "It's all about risk. You get the impression
that the safety hurdle for all drugs is pretty much the same, and it's almost a no-risk hurdle."
"FDA is not even listening to its advisory committees," says Lou Morris, president of Louis A. Morris and Associates. "The
committees are telling them that it's OK to approve certain drugs, and FDA is finding ways to ask more questions. The new
first-in-class drug is going to be harder to get through, which is going to make it even more like drilling for oil. Either
you hit a gusher or you hit a dry well."
Raising the bar: 2006 sales
But not everyone is persuaded that FDA will move further in the direction of overbalancing in favor of safety. "I think the
pendulum is swinging back toward the middle," says Peter Pitts. "The FDA advisory committees and people at FDA are not buying
into the dreaded precautionary principle, which says that unless you know everything you shouldn't do anything."
Who's in Charge?
The safety issue is complicated by the fact that FDA remains under a cloud of suspicion. The agency must address important
issues in the months ahead, including several significant drug approvals (for example, Acomplia, which promises to be the
most-watched launch of the year). FDA's Critical Path initiative, which aims to accelerate drug development, looks increasingly
important, but it might prove politically sensitive because it has the agency cooperating with industry. And, of course, FDA
again finds itself headed by an acting commissioner, Andrew von Eschenbach.
"He's a very qualified guy, and a three-time cancer survivor who feels that every day he's alive is a day to make a difference,"
says Pitts. But it's hard to see any candidate surviving the approval process today. "Given the weakness Bush has, he can't
get anyone appointed now," says Flaum.
Who's at FDA's helm may not be the most important issue, though. "The agency doesn't dramatically alter depending on who's
sitting in the chair," says Miles White. "But I am concerned that some members of Congress are exerting way too much influence
over the agency and compromising its independence."
Richard Nordstrom On Asia, In the United States, we're very computer based. In Europe, it's computer and handheld devices.
In Asia, it's all handheld—no one can afford computers. When you hear what Microsoft and Intel are going to drive market change,
it's the same kind of leapfrog. It's such an interesting dynamic, and it will affect the way we relate to physicians: You
expect Asia to be in the old days, but it's in the new days.
Even if FDA is distracted, the industry will have more than enough regulatory concerns to go around. The Office of the Inspector
General (OIG), with the launch of Medicare Part D, will have oversight of a vastly expanded roster of drugs. State regulation,
especially caps on aggregate promotional spend and various reporting requirements, will continue to increase in importance.
And Europe is starting to more aggressively pursue healthcare fraud investigations like OIG's.