FDA Withdraws Rule Proposing Public Disclosure of IND Data from Gene Therapies

The FDA withdrew a rule proposed in 2001 that would have required the public disclosure of certain data related to unapproved human gene therapy or the transplantation of non-human tissues to humans from companies seeking approval of investigational new drugs.

The agency proposed the rule in part due to concerns over health risks related to modifications of the human genome and the possible effects on future offspring, and looked to boost public discussion. The agency said it reconsidered its position on the issue, and found the proposal outdated.

The FDA said that it will continue to assess rulemaking in this area, and will propose a new rule if it believes it is necessary.