Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), was a case heard before the United States Supreme Court. Abbott Laboratories held that drug companies were not prohibited by the ripeness doctrine from challenging a U.S. Food and Drug Administration (FDA) regulation requiring a prescription drug's generic name to appear on all related printed materials. The government argued that the case was not ripe because the regulation had yet to be enforced; however, that argument failed where prosecution was likely and there was substantial hardship to denying a pre-enforcement challenge to the statute.

Facts

The action was brought by individuals and associations accounting for more than 90 % of the prescription drugs industry. Specifically, the petitioners challenged the decision by the Commissioner of Food and Drug to promulgate the "established name" rule pursuant to a statute granted by Congress. After inviting and considering comments submitted by interested parties, the Commissioner established the following rule:

If the label or labeling of a prescription drug bears a proprietary name or designation for the drug or any ingredient thereof, the established name, if such there be, corresponding, to such proprietary name or designation, shall accompany each appearance of such proprietary name or designation.

External links

• Supreme Court favors reviewability of administrative actions Abbott Laboratories et al. v. Gardner, 87 S. Ct. 1507, 387 U.S. 136 (1967)
• Case brief: Quimbee