Did anyone here really doubt we would win NCE, especially after reading snippets posted by folks who had access to the court transcript? Judge *did* see through the FDA obfuscation just like we thought:
Moreover, although an administrative decision can rely on an agency’s prior
consideration of an issue, the FDA has never addressed why the phrase “active ingredient”
should be given different meanings in different provisions of the Act, let alone explained how the
regulatory focus on “active moiety” can apply where the “active ingredient” and “active moiety”
refer to different substances. The Agency makes no attempt to explain how its approach furthers
Congress’s purposes or is otherwise a reasonable policy choice, especially in light of the clear
interest in providing notice to potential innovators of the exclusivity to which they might
eventually be entitled. And the FDA’s regulations do not provide any further gloss on this point.
The decision to identify a mixture’s “active moiety” based on information available at the time
the FDA evaluates a subsequent drug’s request for exclusivity, rather than at the time drug was
“approved,” is similarly unexplained, and, as discussed above, runs counter to the exclusivity
provision’s purpose of incentivizing innovation.
The Agency’s ultimate conclusion that Vascepa, a drug “no active ingredient of which
. . . has been approved” in a previous NDA, was not entitled to exclusivity, is contrary to the
statute’s plain meaning. Rather than explaining this discrepancy, the administrative decision
only adds to the problem by emphasizing the divergence between the Agency’s regulatory
inquiry and the statutory requirement. Whether the problems with the FDA’s decision are
characterized as failures under Chevron step one, step two, or the APA’s requirement of
reasoned decision-making, the Agency’s decision must be set aside. 11
News 
Market Data 
Discover 
