It’s Complicated: Survey Reveals Rough Patches in FDA’s Working Relationship With Life Sciences Industry

Xconomy San Diego — 

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 … Next Page »

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