Skip to Main Content

Did the Food and Drug Administration treat Amgen (AMGN) differently than Johnson & Johnson (JNJ) when reviewing applications for their drugs?

A federal judge ruled late last week that the agency, in fact, may have acted inconsistently when it denied pediatric exclusivity for a blockbuster Amgen drug and ordered the FDA to explain its reasoning. The ruling could mean that Amgen may eventually win six months of pediatric exclusivity, which would allow the company to forestall generic competition to a best-selling drug.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

  • Given the current battles over “abuse” of orphan drug and pediatric exclusivity to support exorbidant (ok, high) prices, I have some sympathy for the FDAs position.) We’ll see how the case plays out.

Comments are closed.