Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses whether the FDA might involve itself in answering the lingering questions concerning the Biologics Price Competition and Innovation Act (BPCIA).
Do you foresee the FDA stepping in to clarify issues concerning the BPCIA?
Well, they have issued a number of guidance documents and draft guidance documents. I think they’re going to continue to finalize the draft guidance documents they’ve got out there. I don’t think there’s a lot more on the horizon.
The question about [whether they’re] going to do something in response to the court cases is another interesting question; I actually don’t think they are.
The 1 thing they could do, it would be easy, and this is to me the 1 thing they might do, is they could basically say that for biosimilars there is such a thing as tentative approval. That would address some of the issues that have been swirling around as to when you can give the notice that you’re going to start marketing.
That would be very consistent with what they do with [abbreviated new drug applications, aNDAs] and what they do with 505b2 applications, so I don’t think that would be much of a stretch for them. But they really do not want to get involved in any of this BPCIA litigation. I know the courts and some of the litigators are trying to pull them in; I think they’re going to push back and try not to get roped in. At least that’s my guess.