On March 27, 2019, Ha Kung Wong was quoted in The Center for Biosimilars regarding some uncertainty after DOJ signaled approval of the Affordable Care Act (ACA) reversal.
The ACA was signed into law nine years ago and created a biosimilars market in the United States. However, there are uncertainties if the Trump administration is successful in persuading the Fifth Circuit Court of Appeals to affirm a lower court ruling that the law is invalid.
"I think that not having a transition plan or alternative in place for healthcare would make a decision by the Fifth Circuit to affirm the District Court unlikely, at least from a practical impact position, particularly since the legal position supporting complete invalidation of the ACA is debatable,” Wong wrote. "If the Fifth Circuit does affirm the District Court though, I’d expect the Supreme Court to pick up the appeal since they’ve previously upheld the ACA, and they'd want to consider the legal issue more carefully before allowing for the inevitable practical impact on available healthcare."
But, he said, if the lower court's decision is reversed, he would expect the Supreme Court to stay out of the matter for now and let it continue to play out in the lower court.
Regarding the specific impact on the BPCIA and biosimilars litigation if the ACA is repealed, Wong said, "I think the BPCIA will be the subject of significant debate as it looks to be re-passed in Congress, particularly in light of how its applicability has been interpreted by the courts. Though since the [information exchange] process is still considered optional by the courts, [the ruling] might not have an immediate impact on biosimilars litigation."