REMS, FDAAA restrain annual drug-approval rate

The FDA's greater authority and the increased responsibilities bestowed by the FDA Amendments Act in 2007--including its ability to require REMS programs--have conspired to keep drug-approval rates depressed. Despite an increase in the number of drugs approved annually since the high mark of 73 percent in 2006, the 2009 effort yielded a 64-percent approval rate.

BioMedTracker FDA Approval Rates: 2006-2009
Decision Type 2009 2008 2007 2006
Approved 64% 67% 63% 73%
Not-Approved 36% 33% 37% 27%

The 64-percent figure is three points less than the 2008 rate, but one point higher than the 2007 rate, notes Michael Hay, senior analyst at Sagient Research Systems' BioMedTracker research service, in the 2010 FDA Approval Report.

FDAAA dynamics have extended drug approval timelines, he says. In the report, he examines 38 of the 113 drugs that have approved REMS programs. He finds that 18 of the 38 (47 percent) were approved on a first-cycle review. That compares with a traditional overall first-cycle drug approval rate of about 30 percent.

Hay also finds that for 10 of the 18 first-cycle-approved drugs, the FDA missed its time-to-action goal of the timeframe specified in the drug application--the FDA's goal is to review and act within that timeframe on 90 percent of all submissions, and the regulator typically performs in the high-90-percent range.

Drugmakers must "analyze and implement all the elements needed for approval early in the drug development process," he says. "We eagerly await what is again sure to be a thrilling and volatile year for companies navigating the FDA."

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