washington

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) intend to repair a “flaw” in the system under which gene therapy experiments are approved, NIH officials announced last week.

Last year, the authority of the NIH's Recombinant DNA Advisory Committee (RAC) to approve or disapprove gene therapy experiments was shifted to the FDA. But RAC was meant to advise the FDA on new proposals.

But RAC chair Claudia Mickelson says that protocols have been approved by the FDA before RAC, which meets only quarterly, has had a chance to comment.

Lana Skirboll, NIH's associate director for science policy, says the NIH now plans to guarantee “full public discussion of all novel gene therapy protocols before any patient is treated”.

She adds that FDA and NIH are “in full agreement” that RAC's lack of chances to provide input “is frankly a flaw in the system”. Details of the new procedure are expected to be announced in January.

The Senate Appropriations Committee last month adopted language attached to a 1999 spending bill, which “strongly” encourages NIH director Harol Varmus to restore RAC's power to approve or disapprove all human gene therapy experiments.