McClellan defends breakthrough

Former FDA Commissioner Mark McClellan defended FDA's expedited approval programs, including breakthrough therapy designation, in a Harvard Medical School researchers. In response to the researchers' assertion that FDA is using breakthrough therapy designation to apply "increasingly flexible evidentiary standards" for approval, McClellan argued the pathway "does not confer a less rigorous path to approval." He also said all four approved drugs that received the designation are "clear advances in the treatment of life-threatening diseases that previously lacked effective therapies."

The four approved drugs include the cancer drugs Gazyva obinutuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY); Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and partner Johnson & Johnson (NYSE:JNJ); and Zykadia ceritinib from Novartis AG (NYSE:NVS; SIX:NOVN). The other approved drug is HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD). ...