Just a brief follow-up on our post of October 3rd (here) regarding the FDA’s determination that the drug shortage for Tirzepatide is over and the Agency’s “reminder” that, because the shortage has been resolved, 503B compounders should no longer be making the product. Well, a story by Brendan Pierson published by Reuters today (here), titled “Compounding group sues FDA for removing Lilly’s weight loss drug from shortage list,” outlines the basis for the suit and now the battle is on. The FDA was reached by other outlets for comment but only said that the Agency does not comment on ongoing litigation.
This will be an interesting issue to watch as its results could have far-reaching consequences for the FDA’s efforts to regulate 503B compounders.
