November 30, 2010
Obama's FDA more responsive but still s-l-o-w, says industry
Drug and device firms feel FDA has provided better guidance under Obama, but remain frustrated over the slow pace of approvals, a PricewaterhouseCoopers survey found.The survey of 50 life sciences firms found that more than a third (38%) felt that industry-FDA relations had actually improved over the past two years, and fully 80% said the agency is providing better guidance about its expectations. However, the survey revealed lingering doubts about the agency's ability to process new drugs and new indications, given the resources it has to work with, and more than half (56%) of those familiar with FDA's Critical Path Initiative, meant to speed approvals of high priority treatments, think it lacks the resources to make it work.
Six in ten companies complained that FDA had changed position during a review, and four in 10 said some products were denied because of agency understaffing or lack of funding. That said, many companies could strengthen their hand through pre-submission meetings with the agency. Sixty-four percent reported that meeting with FDA before submitting review materials improved the quality of their applications, and 87% said it expedited their applications, but industry did not always take advantage of the meetings and only about half (53 percent) said FDA consistently encouraged these meetings, PricewaterhouseCoopers said.
If industry feels FDA is under-resourced, it's sure not thrilled about paying user fees. Nearly half (46%) of respondents said user fees haven't accelerated the review process, and 48% feel FDA has not been clear about the intended purpose of user fees or transparent about the way they are applied, while 30% feel that user fees are excessive compared with the time that FDA staff spends on reviews. Surprisingly, 22% of industry respondents said user fees create a potential conflict of interest, though half said they don't.
Perhaps less surprisingly, those outside of the industry feel differently. In a separate survey of 1,000 Americans, PricewaterhouseCoopers found 70% opposed to the use of industry funding to accelerate the review process, though only 36% knew that FDA was currently funded, in part, by industry.