Robert Cerwinski: Healthcare Reform and the BPCIA

Robert Cerwinski, JD, Partner at Goodwin, discusses what becomes of the BPCIA if the Affordable Care Act is repealed by Congress.


If the [Affordable Care Act, ACA] is repealed, what becomes of the [Biologics Price Competition and Innovation Act, BPCIA]?

So, the BPCIA is part of the ACA, and if Congress repeals it lock, stock, and barrel, without having some replacement ready to go, technically the BPCIA goes with it, right? I don’t think any of us expect that that’s going to happen, but I’ll tell you that with the current administration and with the current Congress, uncertainty seems to be the rule. The BPCIA so far, in all the debate that we have been hearing and monitoring in Congress and in the administration, seems to be flying completely under the radar. It does not appear to be one of the controversial aspects of Obamacare that the president and Congress are really focused on. From that standpoint, that’s good for biosimilar applicants, but again, because there is this uncertainty, we have at least been watching it. I think I can say that nobody really expects the BPCIA to go away, and we don’t think it is seriously at risk, but certainly we watch what Congress is doing in this respect.

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