In the middle of July, FDA announced a public hearing on facilitating competition and innovation in the biologics marketplace. Following the hearing, September 4, comments were accepted in the docket (FDA-2018-N-2689) until last Friday, September 21.
The agency’s Federal Register notice listed a series of questions, but one of them struck me — at the time — as surprising. FDA asked for comment on the “potential application” of “umbrella exclusivity” for biologics. Why surprising? Because I would not have thought it controversial. More than five dozen comments have been filed, though, and at least one company (Mylan) has argued that the statute doesn’t permit the umbrella.
So it seems like it might be timely to back up and explain this.