Replies to post #101624 on Biotech Values

[zipjet]

it is still irreparable because plaintiffs cannot recover money damages against FDA

I made that argument to MPOWER (another of the attorneys following this) privately.

I do think there is irreparable harm and would find that element met.

ij

[zipjet]

though I don't think it is as clear cut as I had after I had only read the briefs from one side.

I agree.

It seems to me that the prohibition against requiring testing is intended to benefit the applicant (who cannot be required to provide study data) and NOT to promote monopoly pricing of the branded. If in that situation if the court were to find that there was a violation by the FDA, the purpose of the statute would not be promoted by forcing the generic off the market. Quite the opposite.