BioCentury
ARTICLE | Politics & Policy

July 25 P&P Quick Takes: NIH releases more restrictive rules on fetal tissue use; plus SOX, China drug inspections and more

July 27, 2019 12:48 AM UTC

NIH raises bar for use of fetal tissue in research
NIH released details Friday on new rules for the use of fetal tissue in extramural research that require scientists to justify to an ethics advisory board their use of fetal tissue and why the research cannot be accomplished using an alternative, such as pluripotent cells or organoids. In an Editor's Commentary, BioCentury's Washington Editor wrote in June that the new measures would subject every experiment to a months-long review in a process which would effectively strangle applications in red tape. The extramural review requirements follow a ban from the Trump administration prohibiting intramural NIH researchers from using cells derived from fetal tissue. The new rules go into effect Sept. 25 (see "No More Crickets").

Extending SOX
Reps. Trey Hollingsworth (R-Ind.) and Ben McAdams (D-Utah) introduced the Fostering Innovation Act, which seeks to extend to 10 years from five an exemption from certain accounting provisions under Sarbanes-Oxley for prerevenue biotechs. Companion legislation was introduced in the Senate in February (see "Changing SOX? Senate Bill Would Extend Biotech Exemption")...