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Jim Czaban, co-chair of Loeb & Loeb’s Life Sciences industry group, is quoted in Citeline’s Pink Sheet discussing the U.S. Food & Drug Administration’s (FDA’s) decision to release complete response letters (CRLs) for unapproved products, a move that raises significant legal and regulatory implications for sponsors.
Jim notes that when viewed collectively by product category or therapeutic area, the detailed clinical comments could serve as de facto guidance for drug developers.
“It’s at least theoretical that as a whole, and as more of these letters get disclosed, it could actually be a database of FDA guidance without FDA having gone through the guidance process,” Jim told the publication.
Jim Czaban added that while companies might have legal grounds to challenge the FDA’s disclosures in court, the broader backlash could make such lawsuits risky.
“If it’s a company suing FDA saying don’t tell the public this information, they could be right legally but lose the battle, lose the war, because the pushback could be fairly significant,” he said.
To read the full article, visit Pink Sheet’s website (subscription required).
Jim notes that when viewed collectively by product category or therapeutic area, the detailed clinical comments could serve as de facto guidance for drug developers.
“It’s at least theoretical that as a whole, and as more of these letters get disclosed, it could actually be a database of FDA guidance without FDA having gone through the guidance process,” Jim told the publication.
Jim Czaban added that while companies might have legal grounds to challenge the FDA’s disclosures in court, the broader backlash could make such lawsuits risky.
“If it’s a company suing FDA saying don’t tell the public this information, they could be right legally but lose the battle, lose the war, because the pushback could be fairly significant,” he said.
To read the full article, visit Pink Sheet’s website (subscription required).
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Co-Chair, Life Sciences