House committee wants bioethics review of cell, gene therapies

The U.S. House of Representatives Appropriations Committee released a (see BioCentury Extra, May 22).

The House Appropriations Committee also expressed concern about how FDA implements SPA agreements and in the report called for FDA to work closely with companies if it plans to rescind an SPA, noting that FDA can legally rescind an SPA "only if it demonstrates that 'a substantial scientific issue essential to determining the safety or efficacy of the product has been identified after the testing has begun.'" The report directs FDA to "revise and re-issue, after public comment, its existing guidance regarding SPA agreements to clarify the agency's interpretation of the statutory standard regarding SPA agreements and the rescission of such agreements." Amarin Corp. plc (NASDAQ:AMRN) is appealing an SPA that FDA rescinded last year for the Phase III ANCHOR trial of the company's Vascepa icosapent ethyl to treat high triglycerides. The company is appealing the rescission (see BioCentury Extra, Jan. 21). ...