Supreme Court of the United States - BRIEF OF PHARMACEUTICAL COMPANIES,

The Fifth Circuit’s decision in this case radically alters the new drug application (“NDA”) process through which drug applicants (or “sponsors”) seek and maintain Food and Drug Administration approval of pharmaceutical products for sale and marketing, destabilizing the drug development and investment landscape and depriving patients of the benefits of scientific advancement. [...] In the United States, the process of evaluating those medications and changes made to them—and thus ensuring that they are (and remain) safe and effective—is the product of nearly a century of federal legislation delegating oversight of drug approvals to FDA. [...] FDA will approve the NDA only if it concludes that the drug is safe and effective under the conditions of use in the proposed labeling. [...] Instead of relying on FDA’s scientific expertise, and in lieu of following the approval standards established by Congress and implemented by FDA, the court invented its own novel standards for drug development and approval— standards that are wholly unworkable and would deprive industry of the critical stability that comes with FDA approval, including the FDA process for approval of labeling chang. [...] It therefore faulted FDA for “stud[ying] the amendments individually,” “fail[ing] to seek data on the cumulative effect,” and relying on studies “none of [which] examined the effect of implementing all of those changes together” (even though the court acknowledged that some of the studies FDA relied on “considered ‘multiple changes’”).