WASHINGTON -- The Supreme Court Tuesday left intact a ruling that allows the Food and Drug Administration to seize drugs being marketed without government approval.
The justices refused to hear an appeal by a drug manufacturer challenging the FDA's seizure of unapproved drug suppositories that allegedly treat nausea and vomiting.
The focus of the controversy is Alcon Laboratories, of Puerto Rico, which makes drug suppositories called WANS No. 1, WANS No. 2 and WANS Children Anti-Nausea Supprettes.
The company claims the drug is for use in the symptomatic treatment of nausea and vomiting. The drug's active ingredients are pyrilamine maleate, an antihistamine, and pentobarbital sodium, a barbiturate.
The FDA said it has never approved marketing of the ingredients or any similar combination drug for the treatment of nausea and vomiting.
In 1978, the FDA informed Alcon and other drug firms its Neurological Drugs Advisory Committee reported children treated for nausea with drugs containing pyrilamine maleate and pentobarbital experienced severe and sometimes fatal reactions.
The agency advised the firms the drug was unapproved and was being marketed in violation of federal law. All manufacturers except Alcon complied with the FDA's request to take it off the market.
The FDA then seized 454,000 suppositories from Alcon.
Alcon challenged the action in court and won a temporary victory from a federal district judge. But the 1st U.S. Circuit Court of Appeals reversed, ruling the FDA had not violated its enforcement guidelines seizing the suppositories before it held a formal administrative hearing on the dispute.
Alcon took its case to thePx9P9:VP6wP order to keep 'potentially dangerous or ineffective drugs out of the public's hands.'
The case, court file No. 80-1607, was titled Alcon Laboratories vs U.S.