We see the FDA's revised system for granting exclusivity as consistent with the statute and with our Mova decision. It provides, as we said in Mova, that the 180-day exclusivity period for the first applicant begins running upon the occurrence of one of two events, whichever is earlier commercial marketing by the first applicant, or a court decision in favor of the applicant. The second condition obviously presupposes a lawsuit. The first does not. The regulation, as it now stands, is fully consistent with the statute.
Agencies occasionally promulgate a regulation merely du- plicating the underlying statute.
As matters stand after the FDA's revisions, its regulation is of that type. There is nothing irrational in the FDA's giving first applicants the 180-day exclusivity period even if they have not been sued. On its face, the statute does the same. Seen in this light, Purepac's real objection is to the words Congress used, not the FDA's revision of its regulation. Reg. at 50,353.