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ARTICLE · 14 DECEMBER 2010

Supreme Court Docket Report - December 13, 2010

Mayer Brown
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The Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. 301 "et seq.", sets out the process through which generic drug manufacturers receive approval to market their products.

United StatesLitigation, Mediation & Arbitration
Andrew Tauber
Andrew Tauber
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Originally published December 13, 2010

Keywords: Supreme Court, generic drugs, failure-to-warn claims, Telecommunications Act, local exchange carriers

Late Friday, the Supreme Court granted certiorari in two cases of interest to the business community:

  • Generic Drugs—Food, Drug, and Cosmetic Act—Preemption of Failure-To-Warn Claims
  • Telecommunications Act of 1996—Access to Incumbent Local Exchange Carriers' "Entrance Facilities"

Generic Drugs—Food, Drug, and Cosmetic Act—Preemption of Failure-To-Warn Claims

The Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. 301 et seq., sets out the process through which generic drug manufacturers receive approval to market their products. First, a name-brand manufacturer must have obtained FDA approval of the drug and the drug's proposed labeling. Then, manufacturers seeking to market generic forms of the previously approved drug may submit an abbreviated application, which must demonstrate, among other

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