FDA Wants Preemptive Lupus Treatment Suit Nixed

Law360, New York (July 23, 2013, 5:44 PM EDT) -- The U.S. Food and Drug Administration on Monday pushed back against Health Science Funding LLC's novel bid for a declaration that labeling on its lupus treatment Prastera complies with FDA requirements for medical foods, arguing that a New Jersey federal court can’t step into the agency’s shoes and apply its regulations.

The FDA asked the court to dismiss Health Science’s suit, which the drug marketer launched in June after FDA officials allegedly warned at an informal meeting that its lupus treatment might not be considered a...
To view the full article, register now.