Regulatory Litigation in the Innovator Pharmaceutical Industry. FDLI’s Conference on Hatch-Waxman: Past, Present & Future Washington, D.C. Kathleen M. Sanzo, Esq. Morgan, Lewis & Bockius LLP December 11, 2000. Paths to Litigation -- Parties. Innovator Companies Generic Companies FDA FTC
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FDLI’s Conference on Hatch-Waxman: Past, Present & Future
Kathleen M. Sanzo, Esq.
Morgan, Lewis & Bockius LLP
December 11, 2000
Informal (No Lawyers?)
Helps Clarify Scientific Issues
No Obligation for Agency to Meet or Respond
May Delay Overall Strategy
Is Usually Not A Successful StrategyPros and Cons of Informal Meetings/Submissions
Identifies Scientific/Policy Issues for FDA
May Present Significant Issues Delaying FDA Action
Can be disseminated
Provides “Exhaustion” Requirement
Requires Resources (Time and $)
May be Perceived as Anticompetitive
Usually UnsuccessfulPros and Cons of Citizen / Stay Petitions
Product-Specific Citizen Petitions may soon be a thing of the past -- 64 Fed. Reg. 66822 (November 30, 1999); Seealso Federal Trade Commission Comments, InreCitizen Petitions (March 2000)Citizen Petitions (cont’d)
Litigation Scorecard the Approval?
Extra InningsLitigation Batting Average