Manatt Health Partner Rachel Sher was quoted in National Journal and HBW Insight on how a recent Fifth Circuit decision surrounding the availability of a medication abortion drug may impact the Food and Drug Administration’s (FDA) ability to approve other drugs more generally.
There is concern that the decision may set a precedent to challenge FDA’s authority over drug approvals, despite its often intensive approval process. Sher commented on how certain drugs that are perceived as controversial may face additional challenges in the future. “It is the writing of a playbook I would say for private litigants to bring similar cases with respect to other drugs. There’s every reason to think that this kind of challenge and this kind of judicial activism will be replicated with respect to drugs that anyone has all kinds of concerns about,” Sher told National Journal.
National Journal subscribers can read the full article here.
HBW Insight subscribers can read the full article here.