Innovation in Cell and Gene Therapies Could Be Stifled From Draft Guidance Requirements, Commentors Say

November 15, 2023

An FDA draft guidance on reporting manufacturing changes in cellular and genetic therapy (CGT) products puts too much emphasis on clinical trials and neglects the benefits and efficacy of bridging studies, according to comments filed by 16 manufacturers and industry.

The guidance, “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products,” proposes to require manufacturers of all investigational and approved CGTs to notify the agency of any changes in manufacturing that might alter the therapy’s safety or efficacy.

Because CGTs comprise living cells and complex, dynamic genetic actions, statistical or other nonclinical analytic studies might not be adequate to prove comparable safety and efficacy of post-change products, the draft says. In those cases, any changes would have to be followed by clinical studies to prove these points — a demand that could be hard to meet and could even stifle innovation, according to the Biotechnology Innovation Organization.

Read the comments here.

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