Monday, December 13, 1999
BETHESDA, Md. - Responding to public and political concerns raised by recent media attention to gene therapy safety, NIH and FDA have undertaken fundamental reviews of their oversight and regulatory activities that, at a minimum, will result in more stringent requirements to make public disclosures about adverse events that occur during gene therapy trials.
At a three-day meeting of the NIH's Recombinant DNA Advisory Committee (RAC) last week, senior officials from both agencies said they already have moved to more closely integrate their monitoring and regulatory activities, and are considering a wide range of additional steps. At the most extreme, these could restore the RAC's authority to regulate and approve gene therapy trials at institutions that receive federal funding, and prohibit companies from protecting proprietary information in reporting adverse events.