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# Biologics Approvals May Be at Risk: Attorneys
- URL: https://www.fdaweb.com/biologics-approvals-may-be-at-risk-attorneys/
- Published: 2020-07-16T12:00:00.000Z
- Updated: 2026-09-14T16:21:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147215

Four Hogan Lovells attorneys say the Department of Justice (DoJ) is now arguing to the Supreme Court that none of the provisions of the Patient Protection and Affordable Care Act may be severed from the unconstitutional provisions of the act. If the court agrees, they write in an online [post](https://www.jdsupra.com/legalnews/trump-administration-reversal-would-85388/?ref=fdaweb.com), there is a possibility that the Biologics Price Competition and Innovation Act (BPCIA) that was enacted as part of the Affordable Care Act could be declared inseverable and therefore invalid. If that happens, they say, FDA’s authority to approve and regulate products that are biosimilar to approved biological products could be taken away.

The attorneys say that despite the DoJ position, there remain strong arguments in favor of BPCIA severability. First, they say, Supreme Court precedent establishes a presumption in favor of severability unless the inseverable provisions are “so interwoven” with the intended operation of other provisions. The attorneys say that finding the BPCIA severable would be consistent with this precedent because it has little relationship to the health insurance context and is intended to operate independently from the individual mandate.

Also, the relief sought by the plaintiffs in the case against the ACA are the financial harms imposed by the health insurance reforms and thus have no connection to the BPCIA.

The attorneys write that if the Supreme Court were to hold the individual mandate unconstitutional and find the BPCIA inseverable, Congress could always reenact the BPCIA by itself. However, they say, several key provisions of the law are controversial and could impede a swift re-adoption of the act during a time when Congress is focused on other things such as Covid-19\. “For example,” the post says, “the drafting of a new BPCIA would reignite vigorous debates over the length of market exclusivity granted to pioneer biologic manufacturers, as well as other innovator benefits.”

The lawyers suggest that in a period without statutory authority, FDA would be expected to stop approving new biosimilars and application supplements, and would use enforcement discretion to allow the continued marketing of currently approved biosimilars during the interim until Congress provided a legislative solution.