Tracking gene therapies

FDA's policies on long-term follow-up of participants in gene therapy trials involving retroviral vectors are unrealistic and should be replaced with a much less intensive set of requirements, members of the agency's Biological Response Modifiers Advisory Committee said on Friday.

The consensus of BRMAC members was that follow-up observation of gene therapy trial participants extending more than five years should be conducted or supported by government or a non-profit organization and should not be the responsibility of trial sponsors...