May 14, 2021
Terry Mahn Quoted in Bloomberg BNA's "Generic Drugmaker Sues FDA to Get Its Exclusivity Back"
Terry Mahn (Principal) was quoted in Bloomberg BNA article, "Generic Drugmaker Sues FDA to Get Its Exclusivity Back."
Suit Presents Novel Issue.
"I am not aware of any other suits on this forfeiture requirement," Terry G. Mahn, of Fish & Richardson in Washington, told Bloomberg BNA Feb. 1. Mahn practices primarily before the FDA, helping clients with technically complex product authorizations.
Odds of Winning Slim.
"The dispute appears to be very fact-based and that favors the agency," Mahn said. "FDA determines what its review requirements are (and whether they were being reviewed for a change during the ANDA review period) and FDA determines whether its review of these requirements (to the extent there was a review) was a contributing factor in the approval delay."
Showing the FDA acted arbitrarily and capriciously "is a tall hurdle for any plaintiff," he said.
To view the full article, please click here.
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