Drugs

FDA Doubts May Move Trials Overseas: Report

Some biotech companies are considering moving drug trials overseas due to fears about instability in FDA staff and resources. Reuters reports from London that the companies worry that layoffs and policy changes at FDA may delay regulatory reviews.

The article says the news service talked with seven biotech executives, investors, and consultants who said that the FDA staff departures and policy changes had prompted some firms to consider launching trials in international markets such as the European Union and Australia and engage with regulators in those areas earlier in the drug development process.

“We know that across our companies, the discussions include whether to go ex-U.S. because of recent FDA uncertainty,” said RA Capital managing partner Peter Kelchinsky.

Reuters says FDA did not respond to its request for a comment. It reports that consultant Matthew Weinberg of ProPharma Group said his firm is receiving more inquiries from biotech companies about preparing filings with the European Medicines Agency and setting up clinical trials, a shift he attributes to growing concerns about FDA stability.

“Historically, companies went to the U.S. first,” he added. “That may be changing.”

The story says that a loss of confidence in FDA could reshape drug development, reduce U.S. leadership in innovation, and increase costs for the struggling biotech sector, according to five of the interviewees.

Executives said they still intend to run late-stage trials in the U.S. to launch products there. “Europe has been perceived as a little slower,” said 4BIO Capital partner Owen Smith. “But it has benefited, and is benefiting now, from being stable.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome