Generics Lobby Threatens Suit Over FDA Warning Labels Plan

Law360, New York (September 23, 2014, 6:39 PM EDT) -- The Generic Pharmaceutical Association on Tuesday promised to sue if the U.S. Food and Drug Administration finalizes a proposal that would expose generics makers to more personal injury litigation by letting them update their warning labels, urging regulators to instead adopt a compromise.

Ralph G. Neas, the association's CEO, made the vow during a call with reporters regarding efforts to dial back a proposed rule that would end a long-standing practice in which responsibility for revising warning labels falls to brand-name manufacturers.

“The regulatory branch would be changing the law by executive fiat,” Neas said. “We would be forced to go...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS