New drug approval reports seem to cast doubt on critics' charges that the FDA has raised the bar in obtaining drug approvals. NDA approvals are up 18% for the first half of the year compared with approvals during the same period in 2007, the agency said in July.
Through June 30, the FDA had approved 40 NDAs in 2008; at the same time last year only 34 had been approved. However, there was no change in new molecular entity (NME) approvals — for the first six month in 2007 and 2008 the agency approved seven NMEs in each period.
The FDA has been staunchly defending itself from industry complaints that, notwithstanding user-fee deadlines, it has found ways of exceeding them. The FDA suffers no penalty for failing to meet such deadlines.
Last year's FDA Amendments Act, passed with lobbying support from industry, added new approval-delaying burdens on the FDA's drug reviewers, especially with regard to safety concerns, says drugs director Janet Woodcock. She has given safety matters first priority as a result.
The 2008 first-half approval figures probably do not reflect the effects of the new law's demands. If so, the second half probably will—and based on Woodcock's statement, a reduction in approvals may be expected as the FDA gives even more attention to new-drug safety issues. This attention has resulted in the agency issuing more “non approvable” letters to sponsors, even in the face of unanimous advisory committee recommendations that a drug be approved.
“Why bother to have advisory committee meetings when the advice rendered is so often ignored?” asked analyst Ira Loss in a letter to clients.