In a 33-page opinion, Judge Emmet Sullivan of U.S. District Court in Washington, D.C., declined to issue a preliminary injunction blocking the sales of the generic Lovenox.
sanofi-aventis sued the FDA after the agency granted Sandoz approval to make enoxaparin (the generic form of the special heparin).
s-a contended that the FDA didn’t follow its own regulations in granting the approval. s-a, interestingly, didn’t claim that the Sandoz product was unsafe. Rather, they argued that the enoxaparin made by Sandoz is not exactly the same drug as Lovenox and therefore should not be approved or marketed as a copycat version of the blockbuster.
But has anyone ever argued that either traditional Hatch-Waxman generics or FOBS need to be 100% bioequivalent? Indeed, is that even possible? No and no. It is equivalence of functionality based on activity. The generic or the FOB has to work the same way and be designed in ways that produce such functional equivalence. But that doesn’t mean that interchangeability in prescribing is always appropriate. That, however, isn’t a legal matter. It’s a therapeutic one.
Judge Sullivan ruled that the FDA had not acted inappropriately in approving enoxaparin. "Just because the FDA … reached a conclusion at odds with the position advanced by Sanofi does not mean that the FDA's decision was arbitrary and capricious," he said, noting that it has been seven years since s-a filed a citizen's petition at the FDA objecting to generic versions of Lovenox.
He said, the FDA had presented "a satisfactory explanation for its decision." Judge Sullivan noted that none of the parties had challenged the safety of the generic enoxaparin.
And that’s the best victory for both the FDA and the public health.
