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

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

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Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.