Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether Congress might revisit the Biologics Price Competition and Innovation Act (BPCIA).
Might Congress revisit the Biologics Price Competition and Innovation Act (BPCIA)?
In the small-molecule pharmaceutical context, we saw Congress reform the Hatch-Waxman Act several times as procedural issues arose. For example, the Hatch-Waxman Act was amended in 2003 to address some patent listing and enforcement strategies issues. If we continue to see the same sorts of issues arise, or, for example, if we see a number of at-risk launches that end with biosimilar injunctions, Congress could well decide to amend the BPCIA. But one thing I don’t like to predict is what Congress will and won’t do. I think many have tried in the recent past and very few have been accurate.