By Lisa Seachrist
WASHINGTON ¿ Noting that the monitoring of several recent gene therapy trials has been less than adequate, the Food and Drug Administration and the National Institutes of Health announced two new initiatives to further strengthen the safeguards for gene therapy trial participants.
The first initiative is designed to buttress the rigor of FDA oversight of gene therapy trials by requiring that sponsors of those trials routinely submit their monitoring plans to the FDA. The agency will review the monitoring plans and seek modifications when warranted.
The agency will conduct surveillance and ¿for-cause¿ inspections of the clinical trials to ensure the plans are being followed and assess whether the monitoring is adequate to protect the rights and safety of the human subjects involved in gene therapy research.
¿Clinical trial monitoring and responsible reporting must be taken seriously by all parties involved in gene therapy trials,¿ FDA Commissioner Jane Henney said in a press statement. ¿Our plan will help restore the confidence in the trials¿ integrity that is essential if gene therapy studies are to fulfill their potential.¿
The second initiative is designed to enhance patient safety by providing critical forums for sharing and analyzing medical and scientific data from gene therapy research via a series of Gene Transfer Safety Symposia. The symposia will be co-sponsored by NIH and FDA and will take place about four times a year.
The first symposium will take place today at the Recombinant DNA Advisory Committee (RAC) meeting and will discuss the safety and future clinical applications of extensively altered adenoviral vectors. Subsequent symposia will be held at meetings of the RAC and FDA¿s Biological Response Modifier Advisory Committee as well as other venues.
¿We support the concepts of the initiatives,¿ said Michael Werner bioethics counsel and director of federal government relations for the Biotechnology Industry Organization (BIO). ¿It¿s important for the public to be kept informed about these trials in order for them to go forward.¿
Werner will be presenting BIO¿s view when the RAC takes up Jeremy Rifkin¿s proposal for a moratorium on gene therapy research on Friday. Rifkin, a critic of the biotechnology industry, serves as the president for the Foundation on Economic Trends based in Washington.