Biotech Values

[DewDiligence]

Re: FDA disclosure policy on ANDA/351(k) trade secrets

I believe FDA's hands are tied here… Seems to me FDA is forced to require the same testing of all applicants and to inform them what that testing is.

I strongly disagree. There is no FDA requirement that all ANDA/351(k) applicants for a given branded drug use the same exact testing methods for ensuring sameness to the branded drug and batch-to-batch consistency. Nor is the FDA likely to spoon-feed a second or third applicant the testing methods used by the first successful applicant, as was done in the Lovenox case; indeed, doing so, might subject the FDA to a lawsuit by the successful applicant for illegal disclosure of proprietary technology (which is a separate legal issue from the H-W Safe Harbor per se).

The bottom line, IMO, is that the generic-Lovenox case was sui generis. From now on, the FDA will behave differently to avert destruction of the economic foundation of the generic-drug/FoB industry (#msg-84460897).