Senators Press US FDA For Faster Approval Of Generic Insulin
Bipartisan group wants more flexibility for pending applications during NDA-to-BLA transition; Lilly's authorized generic of Humalog suggests political pressure on insulin pricing is having an impact.
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Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.
In congressional testimony, outgoing Commissioner Scott Gottlieb says FDA already has "a lot of applications in-house" and robust interest when asked about the 2020 transition of insulin from regulation as a drug to a biologic.
Letters to Lilly, Novo Nordisk and Sanofi signal potential next avenue for Finance Committee's investigation after CEO hearing on Tuesday.