Menu

The NIH Loosens Grip on Gene Therapy Trials

The agency proposes ceding its scrutiny of these studies to the FDA.

Aug 16, 2018
Kerry Grens

ABOVE: FLICKR, US FOOD AND DRUG ADMINISTRATION

The directors of the National Institutes of Health and the US Food and Drug Administration propose limiting the role of the NIH in assessing proposals for gene therapy experiments, the two explain in a commentary in the New England Journal of Medicine published yesterday (August 15). The NIH’s Francis Collins and FDA’s Scott Gottleib say that the “oversight burden” for gene therapy trials is duplicated by having both agencies involved, and FDA can handle the task on its own.

“We have mechanisms in place to protect patients,” Jeffrey Kahn, director of the Bioethics Institute at Johns Hopkins University, tells the Associated Press. “It doesn’t need to be treated as a special case of clinical research any longer.”

The specific plan, which will be posted to the Federal Register for public comment tomorrow, is to redirect a special NIH panel called the Recombinant DNA Advisory Committee (RAC) away from scrutinizing gene therapy proposals to focus on newer biotechnologies. “In the view of the senior leaders of the FDA and the NIH, there is no longer sufficient evidence to claim that the risks of gene therapy are entirely unique and unpredictable—or that the field still requires special oversight that falls outside our existing framework for ensuring safety,” Collins and Gottlieb write.

RAC was established in 1974 and has evolved over time. In recent years, the panel began to ease its oversight of gene therapy experiments, in accordance with recommendations from the Institute of Medicine. In 2016, RAC decided to only review trials with “exceptional issues or concerns,” a number totaling just three out of 275 protocols, the directors say.

Not everyone is a fan of the proposed oversight shift. “This is not the right time to be making any moves based on the idea that we know what the risks are,” Stanford University bioethicist Mildred Cho, a RAC panel member, tells the Associated Press. She contends scientists don’t understand fully how these complex interventions work—and why they sometimes don’t.

February 2019

Big Storms Brewing

Can forests weather more major hurricanes?

Marketplace

Sponsored Product Updates

Bio-Rad Showcases New Automation Features of its ZE5 Cell Analyzer at SLAS 2019
Bio-Rad Showcases New Automation Features of its ZE5 Cell Analyzer at SLAS 2019
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) today showcases new automation features of its ZE5 Cell Analyzer during the Society for Laboratory Automation and Screening 2019 International Conference and Exhibition (SLAS) in Washington, D.C., February 2–6. These capabilities enable the ZE5 to be used for high-throughput flow cytometry in biomarker discovery and phenotypic screening.
Andrew Alliance and Sartorius Collaborate to Provide Software-Connected Pipettes for Life Science Research
Andrew Alliance and Sartorius Collaborate to Provide Software-Connected Pipettes for Life Science Research
Researchers to benefit from an innovative software-connected pipetting system, bringing improved reproducibility and traceability of experiments to life-science laboratories.
Corning Life Sciences to Feature 3D Cell Culture Technologies at SLAS 2019
Corning Life Sciences to Feature 3D Cell Culture Technologies at SLAS 2019
Corning Incorporated (NYSE: GLW) will showcase advanced 3D cell culture technologies and workflow solutions for spheroids, organoids, tissue models, and applications including ADME/toxicology at the Society for Laboratory Automation and Screening (SLAS) conference, Feb. 2-6 in Washington, D.C.
Corning Introduces New 1536-well Spheroid Microplate
Corning Introduces New 1536-well Spheroid Microplate
High-throughput spheroid microplate benefits cancer research, drug screening