The Supreme Court’s ruling in the Affordable Care Act (ACA) case appears to have saved the biosimilars approval pathway, but do the plaintiffs have other avenues by which to bring another challenge?
On June 17, 2021, the Supreme Court ruled that opponents to the Affordable Care Act (ACA) did not have standing to challenge the law based on the constitutionality of the individual mandate, which provides for a penalty (currently $0) for those who do not obtain health care coverage. Had the Supreme Court struck down the entire ACA, it would have brought an end to the approvals pathway for biosimilars that is contained within the ACA under the Biologics Price Competition and Innovation Act.
The Center for Biosimilars® spoke with Stacie Ropka, PhD, a patent litigator and partner at Axinn, Veltrop & Harkrider of New York, New York, about the significance of this ruling and the conclusions that can be drawn from it.
Ropka discusses the narrow terms upon which the Supreme Court rejected the petition to strike down the ACA. The court ruled on the issue of standing—whether the plaintiffs had suffered harm because of the law—which they had not, rather than the merits of the case. The plaintiffs contended the individual mandate (Section 5000A) is an integral part of the ACA and therefore, if unconstitutional, should be struck down along with the entire ACA. The court never got to that argument.
Ropka explains what course of action may be available at this point for the plaintiffs, a collection of GOP-governed states led by Texas. She discusses the dissenting opinion on the high court and weighs the significance of the ruling for Congress, which created the ACA and now has an opportunity to make it more watertight, or not.
For background reading on the ACA case, read about the June 2021 ruling here, and for background on the withdrawal of the Department of Justice from the plaintiffs’ side of the suit, click here.