What the Potential Elimination of the Biologics Price Competition and Innovation Act Means for Pharmacy

Pharmacy Times^® interviewed Chad Landmon, JD, chair of intellectual property and FDA practice groups at Axinn, Veltrop & Harkrider, on the arguments presented to the Supreme Court on whether a legislative change to the Affordable Care Act (ACA) makes the law unconstitutional, which would, in turn, eliminate Title VII, the Biologics Price Competition and Innovation Act (BPCIA).

During the discussion, Landmon gave a brief overview on the arguments being presented to the Supreme Court regarding the legislative change to the ACA and the implications of a decision by the Supreme Court on the ACA. Additionally, Landmon outlined what the BPCIA is and how a ruling by the Supreme Court could affect the act.

Landmon explained that because of the BPCIA, biosimilar products have come to the market slowly. Some patent litigation has occurred around certain biosimilar products, which has delayed their release onto the market. However, a lot of agreements have been made regarding releasing these products at some point in the future, which would mean that down the line, more biosimilars will begin to come to market and drive down prices.

“It will create other options for pharmacies and pharmacists to dispense these biosimilar versions, which will certainly drive down cost for everybody in the distribution chain,” Landmon said. “If the Supreme Court decided that [the BPCIA] was not severable and it was basically thrown out with the Affordable Care Act, the big question mark gets raised as to what do with the products which have already been approved.”

If this occurred, Landmon explained, the elimination of the BPCIA would also take away the path to market for biosimilar products going forward.

“I think what we heard during the arguments, particularly from Chief Justice [John] Roberts and Justice [Brett] Kavanaugh, seem to be in favor of severability, so in other words, they might throw out the individual mandate, but they'd preserve the rest of it. So, it at least seems like that's where the court is heading,” Landmon said. “It is always so hard to read the tea leaves after listening to a Supreme Court argument. As they go back and put things together, it's always hard to tell where they're going to come out, but at least that's a kind of general sense you get from listening to the questions from the court.”

Landmon also discussed the argument for eliminating the BPCIA and the argument for maintaining it, as well as the potential short-term and long-term implications of the elimination of the BPCIA.