More Delays at FDA?
Several of 2008's most promising NMEs were delayed by FDA, where drug approvals, even for priority reviews, ground to a near
halt as the presidential election approached.
No top pharma needs a blockbuster more than Lilly, which had pinned its hopes on Effient (prasugrel), a first-in-class platelet
inhibitor that was set to race against Plavix until side effects hobbled it—twice—at the gate. The agency has also tossed
two filings for once-a-week GLP-1 inhibitors of diabetes back to their makers, asking for more safety data probably pushing
the launches of Novo Nordisk's liraglutide and Lilly/Amylin's new formulation of Byetta (exenatide) to 2010. Despite requests
for better label and manufacturing info, Roche/Chugai's Actemra, a novel IL-6 blocker for rheumatoid arthritis, is still on
track to hit the market this year.
The potential blockbusters-to-be in 2009 include two from Merck, telcagepant (MK0974), the first in a new class of migraine
drugs in nearly 20 years, and rolofylline (MK-7418) for acute heart failure. Amgen is pinning hopes on its novel osteoporosis
med, a fully human monoclonal antibody dubbed denosumab, while Schering-Plough/Centocor's new anti-TNF agent, golimumab, is
set to storm the rheumatoid arthritis market. Novartis' new vaccine Menveo will save infants worldwide from meningitis. It
remains to be seen whether a new Obama-appointed FDA chief will implement a kinder—or at least quicker—risk/benefit analysis
in deciding the fate of the 25 to 30 new chemical and molecular entities poised for launch in 2009.
No candidate is likely to be named until the Senate confirms Tom Daschle as head of Health and Human Services. Joshua Sharfstein,
MD, the Baltimore health department chief who heads Obama's FDA assessment team, has emerged as the likely front-runner. A
former Waxman policy advisor who spearheaded legislation for federal regulation of tobacco, Sharfstein has earned high marks
as an effective and innovative city health commissioner. Other top contenders are Steve Nissen, MD, the Cleveland Clinic's
chief of cardiology, who has tangled publicly with pharma over drug safety; and Susan Wood, the former head of women's health
at FDA who resigned in protest over the agency's refusal to approve Plan B due to Bush administration pressure. Pharma's unofficial
choice, Janet Woodcock, MD, the current head of CDER and agency veteran, is way back in the pack for that reason.
Critics in pharma view the agency as so paralyzed that almost anyone will be an improvement. "Just give us an end to the turnovers
and the void," says Wyeth's VP of clinical R&D, Evan Loh. In fact, Loh would like Obama to think big—and divide FDA into two
independent agencies. "Separating food and drugs could begin to make consumers feel more confident in the institution and
in drug safety," he says.
Despite their anti-industry rhetoric, Obama and the Democrats are likely to make progress on FDA's most serious problem: a
chronic lack of funding and staff. (For more on what to expect at the agency that everybody loves to hate, see "Coming Attractions
Coming Attractions at FDA