Interchangeable Insulin: One Step Forward, Two Steps Back?

US FDA’s update on the process for converting insulin (and a dozen other complex molecules) from “drug” to “biologic” applications is an important milestone, but framing it as progress towards cheaper medicines for diabetics is a bet of stretch.

In his tenure as US FDA Commissioner, Scott Gottlieb has demonstrated an unsurpassed gift for conveying a sense of progress at the agency in the context of even the most complex or technical of regulatory actions.

But in announcing FDA’s final guidance on the so-called “deeming” process – under which about a dozen ingredients currently approved...

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