| Venue: | SCOTUS |
| Facts: | Commissioner of Food and Drugs issues a new regulation that brand-name drug labels must reference the generic name every time the brand name is mentioned. This would (obviously) impede marketing, but the drug companies are forced with choosing between that and not being compliant. |
| Posture: | District court grants plaintiff's summary judgment motion, court of appeals reverses without reaching the merits, based on a lack of ripeness (nobody has been penalized yet, so there's no case or controversy). |
| Issue: | Did Congress intend to forbid pre-enforcement review of this sort of regulation, when it promulgated the Federal Food, Drug, and Cosmetic Act? |
| Holding: | No. Reversed and remanded. |
| Rule: | There are two things to consider:
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| Reasoning: | Generally speaking, we want to avoid pre-judging things until they're
situated in a real fact patern. In this case, though, everybody
agrees this is a purely legal issue. Also, thre's a severe impact
on the petitioners if nothing is done.
Public confidence in drug products is important, so the companies are understandably nervous about this. And there's no question of standing, here, either: the regulation is squarely aimed at them. |
| Dicta: | |