Medical Marketing and Media - Court blocks FDA regulation, this time on generic drugs
Another FDA regulation was struck down by the U.S. district court in Washington, this time covering the approval process for generic drugs.
Under the law, the first manufacturer to seek approval of a generic drug from the FDA gets a 180-day period of exclusive rights to the market. If the generic drug company faces a patent suit, it can delay the start of the exclusivity period until the case is resolved.
That prevents any other company from marketing the drug, which Judge Richard Roberts said undermines the purpose of the law, to bring speedy approval of generic drugs. Protection should end after the trial judge makes a ruling in a patent case, he said.
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The case relates to Hytrin from Abbott Laboratories. Geneva Pharmaceuticals, a division of Novartis, was the first to file for FDA approval, but was involved in litigation with Abbott for six years. The U.S. Supreme Court in early January refused to consider the Abbott appeal of the Food and Drug Administration’s approval, giving Geneva permission to sell the generic version of Hytrin.
Mylan Laboratories also sought FDA approval to sell the drug, but the agency said it had to wait for Geneva’s exclusivity period to expire. It is this provision in the regulation, the judge ruled that prolongs the period in which generics remain off the market and prices remain inflated, he said.
Copyright CPS Communications Feb 2000
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