FDA: Don't blame us for sparse approvals

Dow Jones has crunched the numbers on the FDA's approval record this year, calculating that the nine new medicines OK'd for marketing in the first half of the year puts the agency on track to match last year's dismal record of 18 approvals [1]. The agency approved 22 new drugs in 2006.

The FDA rejects the notion--put forward by a number of developers [2]--that the agency is getting tougher to deal with after a string of embarrassing drug safety fiascos. From their perspective, each year's record is a result of the quality of development work being done by biopharma companies. This year's crop of new approvals includes Wyeth's Pristiq, Cephalon's leukemia drug Treanda and UCB SA's Cimzia for Crohn's. But there's no annual target.

"It's not like we're trying to race through and get 20 done this year and 18 next year," said the FDA's Sandy Walsh. Applications "come in on a rolling basis and we approve them on a rolling basis."

- read the report [3] from Dow Jones

ALSO: It happens often in drug development: a drugmaker submits an NDA, an expert panel gives the okay, everyone expects an approval--and then the FDA delivers a not-approvable letter. However, only the drug developer ever sees the letter detailing why their drug has been rejected. That's because the FDA is still required by law to keep information on unapproved therapies secret, leading some to suggest that the agency needs to be more transparent. Report [4]

Related Articles:
Drought of approvals gets worse for developers [5]
FDA picking up the pace on '08 approvals [6]
2008 NME approvals no better than last year? [7]
Dry spell or parched desert for NME approvals? [8]
'07's drug approval record raises worries [1]