On October 26, 2020, Ha Kung Wong was quoted in the Center for Biosimilars on how Justice Amy Coney Barrett’s confirmation is likely to affect the Supreme Court’s pending deliberations on the Affordable Care Act (ACA) and whether the biosimilar approval pathway, which is part of that, survives.
According to the article, the Supreme Court will hear oral argument in November on whether the individual mandate portion of the ACA is severable from the entire statute or the whole of the ACA should be abolished, which would mean the end of the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA defines the biologics approval pathway.
Wong said that it’s not clear what Barrett’s opinion on ACA severability would be. In a 2017 article, Barrett discussed the challenge to the individual mandate, but does not appear to have specifically addressed the severability issue or whether she feels the parties to the case have legal standing to challenge the ACA, he noted.
“She’s most likely going to side with the conservatives on the court, but Justice Kavanaugh appears to prefer to sever provisions that are unconstitutional and not strike down whole laws, as he did in Barr v. American Assn. of Political Consultants, and Barrett comes from a similar conservative mold as Kavanaugh and Justices John Roberts and Neil Gorsuch. Also, Roberts previously upheld the individual mandate in 2012, based on Congress' taxing power, apparently due in part over concerns regarding the impact of voiding other parts of the ACA,” Wong said.
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