The life sciences industry says its working relationship with the U.S. Food and Drug Administration has improved, particularly for the early stages of the agency’s product review process. But a survey of 50 life science companies, primarily in California and Massachusetts, also pointed to rising concerns about the latter part of the product review process, as well as about the agency’s ability to keep up with the pace of scientific and technological innovation.
The Pricewaterhouse Coopers accounting firm conducted the survey, the fifth since 1995, with help from San Diego’s Biocom and the Massachusetts Biotechnology Council. While participants included companies developing small-molecule drugs, biologics, medical devices, and diagnostics, Biocom CEO Joe Panetta said, “We tend to focus on the smaller companies that actually had a product in review since the previous survey was done.”
The latest survey, which was completed a few months after Congress passed federal health care reform legislation, also highlighted industry concerns over a requirement for the FDA to establish a process for approving generic versions of biotech drugs (aka biosimilars or follow-on biologics). Participating companies also reacted unhappily to provisions of the Patient Protection and Affordable Care Act that provide funding that could add “comparative effectiveness” as a criterion in the approval process.
Industry concerns that were focused a decade ago primarily on the early stages of regulatory review have shifted now to the latter stages of the review process, Panetta said. The most-recent survey found that 78 percent of the participating companies agreed that FDA guidance documents have increased their understanding of FDA expectations during the drug development process. More than two-thirds (68 percent) said they have done a better job of incorporating regulators’ feedback
But more than 60 percent of the respondents said the FDA changed its position during at least one review, and 56 percent said the regulatory approval process lags scientific and technological advances.
“The last two surveys have shown us some performance issues that have led us to focus on the agency’s ability for timely review of products,” Panetta said. He cited 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.
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