changes in review staff and other “inconsistencies” that led to new requirements during review. Four out of 10 companies surveyed this time around agreed that products were denied because of FDA’s inadequate review resources, and 58 percent agreed that “politics has had too much influence with drug, device, and diagnostics approval.”
Some other findings:
—Sixty-four percent of companies said that meeting with FDA before submitting review materials improved the quality of their applications; 87 percent said it expedited their applications. But the companies said they did not always take advantage of the meetings, and only 53 percent said the FDA consistently encouraged such meetings.
—Of the companies that were familiar with the FDA’s Critical Path Initiative to quickly bring innovative, high-priority therapies to market, 56 percent said the FDA currently lacks the capability to implement the initiative.
—Eighty-eight percent of the participating companies agree that personalized medicine will change the industry’s business model, but only 8 percent of drug and device makers think the FDA is doing enough to advance personalized medicine.
—Forty-six percent of the companies agreed that industry user fees paid to FDA did not accelerate the product review process.
—Forty-eight percent of the companies said the FDA has not been forthright about the intended purpose of user fees or clear about the way they are applied.
—Thirty-percent of the companies agreed that FDA user fees are excessive compared with the time that FDA staff spends on reviews.
—Twenty-two percent of industry respondents agreed that FDA user fees create a potential conflict of interest, although 50 percent disagreed.
