Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Re­pub­li­can rep­re­sen­ta­tives are call­ing on the FDA to take a clos­er look at the ap­pli­ca­tions in­clud­ing on­ly clin­i­cal da­ta from Chi­na.

The let­ter to FDA com­mis­sion­er Rob Califf late last week comes as the agency re­cent­ly re­ject­ed Eli Lil­ly’s an­ti-PD-1 an­ti­body, which at­tempt­ed to bring Chi­na-on­ly da­ta but ran in­to a bruis­ing ad­comm that may crush the hopes of any oth­er com­pa­nies look­ing to bring cheap­er fol­low-ons based on­ly on Chi­nese da­ta.

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